United States securities and exchange commission logo
December 9, 2020
Geoff Green
Chief Executive Officer
LONGEVERON LLC
1951 NW 7th Avenue
Suite 520
Miami, FL 33136
Re: LONGEVERON LLC
Draft Registration
Statement on Form S-1
Submitted November
12, 2020
CIK No. 0001721484
Dear Mr. Green:
We have reviewed your draft 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 providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. 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 the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Draft Registration Statement on Form S-1 filed November 12, 2020
Business Overview, page 1
1. We note your references
on page 1 and elsewhere that "Lomecel-B has a high safety
profile." Please revise
your disclosure here and throughout your prospectus to remove
your characterization
of Lomecel-B as safe, as a determination of whether a product
candidate is safe is
solely within the authority of the U.S. Food and Drug Administration
and comparable
regulatory bodies. We will not object to statements that Lomecel-B
was well-tolerated or
information about the number of treatment related serious adverse
events, but you should
not state or imply that your product candidate is safe.
Geoff Green
FirstName LastNameGeoff Green
LONGEVERON LLC
Comapany9,
December NameLONGEVERON
2020 LLC
December
Page 2 9, 2020 Page 2
FirstName LastName
Clinical Development Pipeline, page 2
2. Please adjust the status bars in the pipeline graph, as appropriate,
to illustrate your product
candidate's current status for each indication. For example, with
respect to your Aging
Frailty indication, we note that your phase 2 trial is currently
on-going, however, the
pipeline graph appears to indicate that the phase 2 trial has been
completed.
3. With respect to the Bahamas Registry Trial, the table appears to
indicate that the product
candidate has been approved but it is still described as a trial.
Please revise your table to
remove the indication that the product has been approved or provide
additional
clarification.
About Our Indications, page 3
4. We note your disclosure that there are no approved medications that
can prevent, stop, or
reverse the progression of Alzheimer's disease. However, according to
the alzheimer's
association website there appear to be two types of medications
cholinesterase
inhibitors and memantine that have been approved by the FDA to
treat the cognitive
symptoms of Alzheimer's disease. Please revise to clarify your
statement or advise.
Financial Overview, page 4
5. Please balance your disclosure to also state that the Company has
experienced significant
losses since inception and expects to incur additional losses in the
future.
We have been funded in part by government and non-profit grant awards..., page
15
6. Please describe the material terms and provisions of grant, contracts
and regulations you
must comply with for continued receipt of government and non-profit
association
funding. Additionally, we note your Exhibit Index appears to indicate
your intention not
to file the referenced contracts or funding agreements. Please provide
us with an analysis
supporting your conclusion that your are not required to file them
pursuant to Item 601 of
Regulation S-K.
Risks Related to Intellectual Property, page 20
7. We note that you may be subject to federal regulations, such as
march-in rights. Please
provide additional disclosure regarding the technology or technologies
subject to march-
in rights; the portion of your business that would be affected by the
exercise of march-
in rights; and whether and how you may be compensated in the event
such rights are
exercised.
Holders of our Class B common stock will control the direction of our
business..., page 39
8. Please revise the discussion to identify the four holders you
reference.
Industry and Other Data, page 48
Geoff Green
FirstName LastNameGeoff Green
LONGEVERON LLC
Comapany9,
December NameLONGEVERON
2020 LLC
December
Page 3 9, 2020 Page 3
FirstName LastName
9. Your statement that your internal company research as well as third
party information
regarding market and industry data has not been independently verified
and that the
accuracy and completeness of such information is not guaranteed
implies a disclaimer of
responsibility with respect to such information. Please either delete
the statement or
specifically state that you are liable for the information related to
the market and industry
data and your internal company research.
Use of Proceeds, page 48
10. We note your disclosure that you intend to allocate a portion of the
proceeds from the
offering to fund research, including clinical trials and product
development for our
existing pipeline. Please revise your disclosure identify each of the
indications you intend
to advance with the funds from the offering and how far in the
development process for
each indication you estimate that the allocated proceeds from the
offering will enable you
to reach.
Impact of COVID-19, page 54
11. We note your disclosure related to disruption in executing follow up
visits and mitigation
efforts. To the extent you had participants drop out of clinical
trials, were not able to
conduct follow up visits or need to increase the number of
participants for any other
reason related to pandemic related disruptions, please expand your
disclosure to discuss
these impacts and consider applicable risk factor disclosure.
Management s Discussion and Analysis of Financial Conditions and Results of
Operations
Results of Operations
Research and Development Expenses, page 57
12. Given the importance of your research and development expenses to your
operations,
please consider including disaggregated disclosure of the nature of
expenses incurred for
each period.
Emerging Growth Company Status, page 63
13. Here and on page 7 you state you have elected to take advantage of the
extended transition
period for complying with new or revised accounting standards under
Section 107(b) of
the JOBS Act. However, your risk factor disclosure on page 41 states
that you have
irrevocably elected not to avail yourselves of this exemption from new
or revised
accounting standards. Please correct these apparent inconsistencies.
If you elect to opt
out of these provisions, please indicate as such on the cover page.
Our Strategy, page 64
14. Please remove statements that your grant funding awards "demonstrate
the acceptance and
support by the scientific community, giving high credibility to our
programs," as many
Geoff Green
FirstName LastNameGeoff Green
LONGEVERON LLC
Comapany9,
December NameLONGEVERON
2020 LLC
December
Page 4 9, 2020 Page 4
FirstName LastName
research programs supported by the scientific community fail to
achieve FDA approval.
Clinical Development Pipeline, page 66
15. With respect to Aging Frailty and Metabolic Syndrome, please also
include in your
discussion that according to the FDA, neither of such indications
presently have
definitions that are acceptable for characterizing the conditions for
regulatory purposes
and that the FDA and the Japanese PMDA have both indicated that the
concept of
Frailty or the Metabolic Syndrome as an indication will require
additional clinical data
and discussion before future pivotal trials and marketing
authorization.
License Agreements and Strategic Collaborations, page 68
16. With respect to the License Agreement with the University of Miami,
describe the nature
of the use granted. For example, were you granted a worldwide
exclusive license to
develop and commercialize the intellectual property. Please also
disclose the royalty term
and the termination provisions under the agreement and quantify
amounts paid to date, if
any
17. With respect to the License Agreement with JMHMD Holdings, describe
the nature of the
use granted. Please also disclosure the royalty term and termination
provisions. We also
note your disclosure that there were no license fees due during the
nine months ended
September 30, 2020 and 2019 pertaining to this agreement. Please
revise your disclosure
to disclose the aggregate amounts paid under the agreement and
potential milestone
payments, if any.
U.S. Phase 2b Multicenter, Randomized, Double-Blinded, Placebo-Controlled
Trial, page 72
18. We note your discussion of the Phase 2b clinical trial for your Aging
Frailty
Program. Please clarify whether there was a Phase Phase 2a trial and
whether it has been
completed.
Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS), page 81
19. We note your disclosure that HLHS is an ultra-rate indication and
would therefore qualify
for an orphan drug designation and potentially for orphan drug
exclusivity if FDA
approved and that you may have the opportunity to pursue one of the
FDA s expedited
review programs for this use. Please revise your disclosure to
clarify, if true, that the FDA
has not given any indication as to whether your product candidate will
receive
an orphan drug designation or exclusivity or be permitted to use
expedited regulatory
pathways.
Experts, page 131
20. Your expert language here only refers to the financial statements at
December 31, 2019
and for the year then ended. Please revise to cover the same periods
as the auditor s
report on page F-2.
Geoff Green
LONGEVERON LLC
December 9, 2020
Page 5
Financial Statements
Note 2. Summary of Significant Accounting Policies
Inventory, page F-7
21. Here you refer to a biological segment of your operations. Please
clarify for us, and revise
if necessary, whether you have reporting segments as defined under ASC
280. If so,
please provide the required disclosures under ASC 280-10-50.
Intangible Assets, page F-8
22. Here you disclose that intangible assets include legal costs incurred
related to patents and
trademarks. You also disclose on page 55 that general and
administrative expenses
include legal fees relating to intellectual property. Please reconcile
the two statements for
us including clarifications for the nature of costs, and timing for
asset recognition. Revise
your disclosures if necessary. Please cite the relevant accounting
references in your
response.
Note 8. Commitments and Contingencies
Exclusive Licensing Agreements , page F-16
23. Please explain to us, and revise if necessary, how these licensing
agreements contributed
to your intangible assets disclosed on page F-8. Also, revise to
disclose where you have
included the annual fees paid under the UM agreement and the legal
fees paid under the
CD271+ agreement in the financial statements.
Exhibits
24. Please file the promissory note evidencing the Company's PPP loan as
an exhibit to the
registration statement, pursuant to Item 601(b)(10) of Regulation S-K.
Alternatively,
please explain to us why such disclosure is not required.
You may contact Li Xiao at 202-5514391 or Lynn Dicker at 202-551-3616 if
you have
questions regarding comments on the financial statements and related matters.
Please contact
Deanna Virginio at 202-551-4530 or Suzanne Hayes at 202-551-3675 with any other
questions.
FirstName LastNameGeoff Green Sincerely,
Comapany NameLONGEVERON LLC
Division of
Corporation Finance
December 9, 2020 Page 5 Office of Life
Sciences
FirstName LastName