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United States securities and exchange commission logo
June 2, 2021
Timothy Noyes
Chief Executive Officer
Aerovate Therapeutics, Inc.
200 Berkeley Street, Floor 18
Boston, MA 02116
Re: Aerovate
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted May 6,
2021
CIK No. 0001798749
Dear Mr. Noyes:
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
Prospectus Summary
Overview, page 1
1. We note your statement
that "oral imatinib also demonstrated statistically significant and
clinically meaningful
benefit in PAH patients in an international Phase 3 trial conducted
by Novartis" and
similar statements throughout the registration statement. Since findings
of safety or efficacy
are solely within the authority of the FDA or similar foreign
regulators, and oral
imatinib has not been approved for the treatment of PAH, please
revise to remove any
statements that suggest the safety and efficacy of this product
candidate. Where you
deem appropriate, you may present objective data without
including your
conclusions related to safety or efficacy.
Timothy Noyes
FirstName LastNameTimothy
Aerovate Therapeutics, Inc. Noyes
Comapany
June 2, 2021NameAerovate Therapeutics, Inc.
June 2,
Page 2 2021 Page 2
FirstName LastName
2. We note your comparison of the results of your Phase 1 trial of AV-101
to the results
observed in the Phase 3 IMPRES clinical trial of oral imatinib. Given
that it appears you
have not conducted head-to-head trials, and the significant variables
across clinical
trials, please tell us why you believe it is appropriate to include
this comparison. Include
in your response whether you expect to be able to rely on this data to
support an
application for marketing approval from the FDA or comparable
regulatory body for
commercialization of AV-101.
3. Please describe the systemic" adverse events that were observed
during the Phase 3 trial
conducted by Novartis and whether these were categorized as serious
adverse events.
4. We note your use of the term high unmet medical need here and
elsewhere in the
document. Such a term might imply that your products are eligible for
fast track
designation or priority review granted by the FDA for products that
treat certain serious
unmet medical needs. Please remove your use of this term throughout or
otherwise please
explain why you believe use of this term is appropriate.
5. We note your statement that you have received regulatory guidance from
the FDA that
your clinical program could support a NDA submission. Please revise to
provide context
for such statement and balance your disclosure by stating that the
process of clinical
development is inherently uncertain and there can be no guarantee that
you will obtain
marketing approval. We also note your statements that your "focus on
developing AV-
101 is driven by promising historical results from the Phase 3 IMPRES
clinical trial of
oral imatinib," that you are "pursuing an efficient clinical
development program utilizing
established endpoints for development and approval of previous PAH
drugs" and similar
statements throughout the registration statement. These statements
could imply that the
FDA has approved, or will more easily approve, your product candidate.
As your drug is
distinct from prior drugs that have been approved by the FDA, please
revise your
disclosure to remove any implication that your product candidate is
more likely to receive
FDA approval than others. Additionally, revise your statements on page
79 that you
intend to pursue a "rapid development path" that "employs a seamless
adaptive design to
streamline the development timeline to a potential NDA filing" and
similar disclosure
throughout the prospectus to remove any implication that you will be
successful in
obtaining regulatory approval or commercializing your product
candidate in a rapid or
accelerated manner as such statements are speculative.
Risks Associated with Our Business, page 3
6. Please revise this section as follows:
Add a bullet point highlighting that your patent portfolio is
pending and that you do
not own any issued patents with respect to AV-101. In this
regard, we note your
disclosure on page 30.
Add a bullet point highlighting the risks related to the
concentration of ownership of
your common stock, as discussed on page 49. Please include in
this bullet and in the
Timothy Noyes
FirstName LastNameTimothy
Aerovate Therapeutics, Inc. Noyes
Comapany
June 2, 2021NameAerovate Therapeutics, Inc.
June 2,
Page 3 2021 Page 3
FirstName LastName
corresponding risk factor on page 49 a discussion of the number
of your executive
officers and directors who are affiliated with your principal
stockholders.
Expand your disclosure in the ninth bullet point or add a new
bullet point to highlight
that you plan to conduct clinical trials for AV-101 outside the
United States and that
if the FDA, EMA, or any applicable foreign regulatory authority
does not accept such
data, it would result in the need for additional trials, as
discussed on page 38. Please
also revise the disclosure in your prospectus summary to discuss
that you plan to
conduct your clinical trials outside the United States and
clarify where you conducted
your Phase 1 trial.
Use of Proceeds, page 60
7. Please revise your disclosure that you expect to use net proceeds from
this offering to fund
further development of AV101, including the global Phase 2b/3 clinical
trial, to provide
an estimate of how far in the clinical development process for AV101
the allocated
proceeds of the offering will enable you to reach. For example, if you
will not complete
the Phase 2b or Phase 3 portion of the trial, please revise to so
state. If any material
amounts of other funds are necessary to complete your clinical trials
for this candidate,
please revise your disclosure to state the amounts and the sources of
such other funds.
Refer to Instruction 3 of Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Common Stock Valuations, page 74
8. Please disclose the fair value of your common stock for each grant
date of stock-based
awards, as determined by your board of directors, as well as the
significant actual factors
considered by them in their determination of fair value. As part of
the revised disclosure,
identify the reasons for grant date-over-grant date changes in fair
value.
Business
Intellectual Property, page 93
9. Please revise your intellectual property disclosure to disclose for
each material patent
application the specific products or technologies to which such patent
applications relate.
Also clearly describe on an individual basis the type of patent
protection sought for each
product or technology (composition of matter, use, or process), the
expected expiration of
each patent, and the jurisdiction, including any foreign jurisdiction,
of each pending
patent. In this regard, it may be useful to provide this disclosure in
tabular form to support
the narrative already included.
Competition, page 95
10. We note your statement that AV-101 is a "potentially first-in-class
inhaled medication"
targeting certain PAH patients. Given the stage of development, and
your
Timothy Noyes
Aerovate Therapeutics, Inc.
June 2, 2021
Page 4
acknowledgement that obtaining FDA approval is inherently uncertain, this
statement
would appear to be premature. Please revise this statement as
appropriate.
Employment Arrangements with Our Named Executive Officers, page 122
11. We note your disclosure on page 122 that you have entered into offer
letter agreements
with certain of your named executive officers. We also note your
disclosure on page 126
regarding the Senior Executive Cash Incentive Bonus Plan. Please file
such
offer letter agreements and the Senior Executive Cash Incentive Bonus
Plan as exhibits
pursuant to Item 601(b)(10) of Regulation S-K.
General
12. Please confirm that you will update your disclosure for any shares you
become obligated
to issue under the Stock Purchase Agreement prior to the completion of
the initial public
offering.
13. 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 Michael Fay at 202-551-3812 or Al Pavot at 202-551-3738
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Kasey Robinson at 202-551-5880 or Christopher Edwards at 202-551-6761 with any
other
questions.
Sincerely,
FirstName LastNameTimothy Noyes
Division of
Corporation Finance
Comapany NameAerovate Therapeutics, Inc.
Office of Life
Sciences
June 2, 2021 Page 4
cc: Edwin O Connor, Esq.
FirstName LastName