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United States securities and exchange commission logo
June 13, 2022
Natalie Holles
Chief Executive Officer
Third Harmonic Bio, Inc.
300 Technology Square, 8th Floor
Cambridge, Massachusetts 02139
Re: Third Harmonic Bio,
Inc.
Draft Registration
Statement on Form S-1
Submitted May 16,
2022
CIK No. 0001923840
Dear Ms. Holles:
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 May 16, 2022
Cover Page
1. We note that you intend
to apply to list your common stock on the Nasdaq Global Market.
Please revise to state
whether such listing is a condition of the offering. If such listing is
not a condition of the
offering, discuss the liquidity implications for participants in the
offering.
Prospectus Summary, page 1
2. We note your statement
that you intend to initiate certain trials following "anticipated
regulatory clearance."
Please revise your disclosure to remove any implications that your
product candidate will
receive regulatory approval. Please also balance your disclosure
Natalie Holles
FirstName LastNameNatalie Holles
Third Harmonic Bio, Inc.
Comapany
June NameThird Harmonic Bio, Inc.
13, 2022
June 13,
Page 2 2022 Page 2
FirstName LastName
here to state when you anticipate submitting your clinical trial
applications, that there is no
guarantee that your application will be approved, and that even if it
is, there is no
guarantee that your trials will begin within your anticipated
timeframe.
3. We note that you plan to plan to seek regulatory approval to
commercialize THB001 or
any future product candidates in the United States. However, it is
unclear from the
disclosure whether you have applied to the FDA for an IND for this
drug. Please advise. If
you do not have an IND for this drug, please specifically state so in
your disclosure, and
provide an estimated timeline for your IND application.
4. You make several statements throughout your prospectus that imply the
efficacy of your
product candidates. Efficacy determinations are solely within the
authority of the FDA (or
applicable foreign regulator) and are assessed throughout all clinical
trial phases. You may
present clinical trial end points and objective data resulting from
trials without concluding
efficacy. Please revise or remove these and similar
statements/inferences throughout your
prospectus:
Any statements implying that your products improved or may
potentially improve
symptoms or outcomes, such as "TBH001 was able to produce notable
airway improvements in a rat model of allergic asthma" or "the
administration of
THB001 demonstrated statistically significant mast cell
suppression";
Any statements referencing "promising", "favorable", or
"strong" results from your
studies; and
Any statements referencing your product's "potential" to affect
symptoms or
outcomes, such as " THB001 has the potential to minimize these
off-target effects
and enable us..."or its "ability to potentially treat a range of
mast cell mediated skin,
respiratory and gastrointestinal conditions..."
5. Please revise your pipeline to include, in distinct columns, all the
phases yet to be
completed. Clarify, by product and indication, to which stage each has
been developed.
Use of Proceeds, page 70
6. We note that the use of proceeds may vary significantly from your
current intentions
depending on a number of factors and management will have broad
discretion in the
application of the net proceeds. Please revise your disclosure to
comply with Instruction
7 to Item 504 of Regulation S-K, or delete the reservation regarding
the use of proceeds
from this section and from the risk factor on page 61.
7. We note your statement that the net proceeds of this offering will not
be sufficient for you
to fund any of your products through regulatory approval and that you
will need to raise
substantial additional capital to complete the development of your
product
candidates. Please revise your use of proceeds disclosure to indicate
how far you expect
the proceeds to progress each of the listed uses. If you will not be
able to complete the
related trials and address the related development costs with the
proceeds of the offer,
please disclose that these goals will not be achievable without
additional funding and state
Natalie Holles
Third Harmonic Bio, Inc.
June 13, 2022
Page 3
the amounts and sources of other funds needed for each specified purpose
and the sources.
For guidance, please refer to Item 504 of Regulation S-K.
Certain Relationships and Related Party Transactions, page 115
8. We note your consulting agreements with Mark Iwicki and Martin Seidel.
Please disclose
the nature of the consulting services provided by Mr. Iwicki and Mr.
Seidel in each of
these agreements.
Government Regulation, page 117
9. We note your disclosure throughout your prospectus that you intend to
market THB001 in
the United States and the European Union, that you have an existing
"CTA," and intend to
submit a clinical trial application for your Phase 1b trial. Please
briefly describe how the
drug approval process works in the European Union, including the
significance of a
clinical trial application within this jurisdiction, the steps required
to receive approval, and
the steps you have taken to date to receive approval. Please also
disclose in the related
portion of the Business Section what "CTA" stands for, when you received
approval for
your existing CTA and when you intend to submit your clinical trial
application.
General
10. 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.
You may contact Franklin Wyman at 202-551-3660 or Lynn Dicker at
202-551-3616 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jordan Nimitz at 202-551-5831 or Celeste Murphy at 202-551-3257 with
any other
questions.
Sincerely,
FirstName LastNameNatalie Holles
Division of
Corporation Finance
Comapany NameThird Harmonic Bio, Inc.
Office of Life
Sciences
June 13, 2022 Page 3
cc: Rob Freedman, Esq.
FirstName LastName