View:
United States securities and exchange commission logo
May 26, 2021
Mir Imran
President and Chief Executive Officer
Rani Therapeutics Holdings, Inc.
2051 Ringwood Avenue
San Jose, California 95131
Re: Rani Therapeutics
Holdings, Inc.
Draft Registration
Statement on Form S-1
Submitted April 27,
2021
CIK No. 0001856725
Dear Mr. Imran:
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, Submitted April 27, 2021
Cover Page
1. To facilitate an
understanding of your corporate structure and the use of proceeds, please
revise the prospectus
cover page to explain that you will be implementing an Up-C
structure in connection
with this offering and clearly identify both the holding and the
operating companies.
2. Please revise the
disclosure of your controlled company status on the prospectus cover
page to include the
amount of the voting power the controlling shareholder will own
following the
completion of the offering and, if true, that you do not intend to comply
with certain corporate
governance requirements.
Mir Imran
Rani Therapeutics Holdings, Inc.
May 26, 2021
Page 2
Prospectus Summary, page 1
3. We note your disclosure that RT-110 may be able to meet the need for a
more effective
treatment for hypoparathyroidism. As safety and efficacy
determinations are solely within
the authority of the FDA and comparable regulatory bodies, it is
inappropriate to state or
imply that your product candidates are safe or effective. Please
revise this statement and
similar statements throughout your prospectus that suggest the safety
and efficacy of your
candidates. Where you deem appropriate, you may present objective data
without
including your conclusions related to safety or efficacy. By way of
example only, we
note the following statements:
your trial results "validate the utility of the RaniPill capsule
to deliver octreotide
orally" and "validate the utility of the RaniPill capsule for
other biologics"
administration of adalimumab via the RaniPill capsule is "an
effective alternative to
painful SC injections"
the RaniPill capsule "can be safely consumed on a daily basis for
seven days" and "its
remnants can be safely excreted without any complications"
4. We note your disclosure that your plan to create a Master File for the
RaniPill capsule
"will serve to significantly de-risk the regulatory pathway for
biologic drugs delivered via
the RaniPill capsule." Please remove this statement and any other
statements that imply
that you will be successful in mitigating risk associated with drug
development.
Risks Associated with Our Business, page 10
5. Please revise your prospectus summary to discuss that your clinical
trials to date have
been conducted outside the U.S. Please also expand your disclosure in
the sixth bullet
point to highlight the risk that your clinical trials have been
conducted outside the U.S.
and that if the FDA or comparable regulators do not accept earlier
preclinical and clinical
data you may need to conduct additional clinical trials, as discussed
on page 39.
Market, Industry and Other Data, page 94
6. Your statements that (i) you have not separately verified the data from
third parties, (ii)
your internal research has not been verified by any third party, and
(iii) investors are
cautioned not to give undue weight to any such information, projections
and estimates,
FirstName LastNameMir Imran
may imply an inappropriate disclaimer of responsibility with respect to
such information.
Comapany NameRani
Please Therapeutics
either delete Holdings,
these statements Inc.
or specifically state that you are
liable for the
May 26,information
2021 Pagerelated
2 to the market and industry data and your internal
research.
FirstName LastName
Mir Imran
FirstName LastNameMir Imran
Rani Therapeutics Holdings, Inc.
Comapany
May NameRani Therapeutics Holdings, Inc.
26, 2021
May 26,
Page 3 2021 Page 3
FirstName LastName
Use of Proceeds, page 95
7. Please revise your use of proceeds disclosure as follows:
Revise to state the approximate amount of offering proceeds
intended to be used for
each of your intended uses of proceeds. In addition, provide an
estimate of how far
in the clinical development process for each of your product
candidates the allocated
proceeds of the offering will enable you to reach. Refer to Item
504 of Regulation S-
K.
It appears from your disclosure that the proceeds from the
offering will not be
sufficient to fund development of your product candidates through
regulatory
approval and commercialization. Please disclose the amounts and
the sources of
other funds needed to reach regulatory approval and
commercialization for each
product candidate. Refer to Instruction 3 to Item 504 of
Regulation S-K.
With respect to the repayment of your outstanding PPP Loan with
Comerica Bank,
revise to disclose the interest rate and maturity of such
indebtedness. If the debt
under the PPP Loan was incurred within one year, also describe the
use of the
proceeds of such indebtedness other than short-term borrowings
used for working
capital. Refer to Instruction 4 to Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development Expenses, page 126
8. We note the discussion on page 123 that you do not track research and
development costs
on a project-by-project basis. Please revise the filing to disclose
and discuss research and
development costs by the nature of expense for each period presented.
Liquidity and Capital Resources, page 127
9. Please revise your liquidity disclosures to address the fact that you
are a holding company
with no operations of your own and that you depend on your
subsidiaries for cash. Please
also disclose any restrictions or other factors that could inhibit
your subsidiaries' ability to
pay dividends or make other distributions to the parent company.
Please refer to Item
303(a)(1) of Regulation S-K.
10. Please revise your liquidity disclosures to address the Tax Receivable
Agreement,
disclosing your estimates of potential future payments. In this
regard, we note your
statements that you expect the future payments under the agreement
could be significant.
This information should also be disclosed in the Summary and in the
relevant risk factors.
Business
Core Programs, page 155
11. We note your disclosure that you commissioned a market research study
and your
references to your survey conducted by Frost & Sullivan. With respect
to the statements
in your prospectus that are based on such data, please revise to
clarify whether such
Mir Imran
Rani Therapeutics Holdings, Inc.
May 26, 2021
Page 4
statements are statements of the third party or statements of the
registrant. If your
disclosure attributes a statement to the third party, or if you
commissioned any
other market or industry data cited in the prospectus, please revise
your filing to identify
such third party and file a consent from such third party. Please see
Securities Act Rule
436 and Question 233.02 of the Securities Act Rules Compliance and
Disclosure
Interpretations.
Evaluation Agreements, page 160
12. For each of the Novartis Evaluation Agreement, Takeda Evaluation
Agreement and
CCHN Agreement, please revise to disclose the duration of the
agreement, the aggregate
potential future payments to be paid or received, and the termination
provisions. In
addition, please expand your disclosure to describe more clearly the
nature and scope of
the intellectual property transferred under these agreements and each
party's rights and
obligations. Please also file these agreements as exhibits or provide
your
analysis identifying how you determined that these agreements did not
need to be filed as
exhibits pursuant to Item 601(b)(10) of Regulation S-K.
13. We note your disclosure on page 201 regarding your Intellectual
Property Agreement and
Exclusive License Agreement with InCube Labs, LLC. Please disclose
here the material
terms and duration of each agreement, any aggregate amounts paid or
received to date,
and any aggregate future potential payments to be paid or received
under each agreement.
With respect to the Exclusive License Agreement, please also revise to
clarify when
the last-to-expire patent that is licensed to you is expected to
expire.
Intellectual Property, page 162
14. Please revise your intellectual property disclosure to disclose for
each material patent and
patent application the specific products or technologies to which such
patents or patent
applications relate. Also clearly describe on an individual basis the
type of patent
protection granted for each product or technology (composition of
matter, use, or process),
whether the patents are owned or licensed, the expiration of each
patent held, and the
jurisdiction, including any foreign jurisdiction, of each pending or
issued patent. In this
regard, it may be useful to provide this disclosure in tabular form to
support the narrative
already included.
Executive Compensation
New Employment
FirstName Agreements,
LastNameMir Imran page 190
Comapany
15. NameRani
Please Therapeutics
file a form of the new Holdings,
employmentInc.agreement(s) to be entered
into with each of the
named
May 26, 2021 executive
Page 4 officers, to be effective upon the closing of the offering.
FirstName LastName
Mir Imran
FirstName LastNameMir Imran
Rani Therapeutics Holdings, Inc.
Comapany
May NameRani Therapeutics Holdings, Inc.
26, 2021
May 26,
Page 5 2021 Page 5
FirstName LastName
General
16. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
17. Please revise your pipeline table and other graphics throughout your
filing to ensure that
the text in all graphics, including footnotes, is legible.
You may contact Tracey McKoy at 202-551-3772 or Kevin Kuhar at
202-551-3662 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Kasey Robinson at 202-551-5880 or Laura Crotty at 202-551-7614 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Josh Seidenfeld