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United States securities and exchange commission logo
September 18, 2021
Raju Mohan, PhD
Chief Executive Officer
Ventyx Biosciences, Inc.
662 Encinitas Blvd., Suite 250
Encinitas, CA 92024
Re: Ventyx Biosciences,
Inc.
Draft Registration
Statement on Form S-1
Filed August 20,
2021
CIK No. 0001851194
Dear Dr. Mohan:
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 August 20, 2021
Overview , page 1
1. Please remove the
references throughout your prospectus to potential "first-in-class" or
"best-in-class" product
candidates as these descriptions imply an expectation of regulatory
approval and are
inappropriate given the length of time and uncertainty with respect to
securing marketing
approval.
2. We note your statements
that VTX958 is a "potent" and "highly selective" tyrosine kinase
type 2 inhibitor; that
VTX958 has "leading selectivity profile and broad therapeutic
window;" that VTX002 is
a "potent" and "highly selective" sphingosine 1 phosphate
receptor 1 modulator
and "showed a robust, dose-dependent, steady-state reduction in
ALC..."; that VTX958
has demonstrated a "wide safety margin"; that you are pursuing a
Raju Mohan, PhD
FirstName LastNameRaju
Ventyx Biosciences, Inc. Mohan, PhD
Comapany 18,
September NameVentyx
2021 Biosciences, Inc.
September
Page 2 18, 2021 Page 2
FirstName LastName
"promising therapeutic approach;" that you have developed a "potent"
and "highly
selective" NLRP3 inhibitor; that VTX2735 has demonstrated "potent
NLRP3 inhibition;"
that VTX2735 has demonstrated "potent in vivo pharmacodynamic
activity," that
"VTX2735 has a broad therapeutic window," and that you have a
diversified pipeline of
"promising product candidates." Please revise these and similar
statements throughout
your prospectus to eliminate conclusions or predictions that your
product candidates are
safe and effective, as determinations of safety and efficacy are
solely within the authority
of the FDA. You may provide an objective summary of the data that you
used to draw
these conclusions, and such discussion is more appropriate in the
Business section where
full and proper context can be provided.
3. We refer to the last two rows in your pipeline table. Please expand
your disclosure in your
Business section to provide a more fulsome discussion of these
programs, including
identifying the target and program for each product candidate as well
as including a
description of preclinical studies or other development activities
conducted. Alternatively,
please explain to us why these programs are sufficiently material to
your business to
warrant inclusion in your pipeline table.
4. Please revise your Summary to provide a brief description of your
corporate organization
and structure, including a discussion of your recent acquisitions of
Oppilan Pharma Ltd.
and Zomagen Biosciences Ltd.
Our Competitive Strengths, page 2
5. We note your statements that you believe your deep internal drug
discovery and
development expertise and that you are able to "mitigate some of the
risks usually
associated with new product development." Please revise these and
similar statements
throughout your prospectus to remove any implication that you will be
successful in
advancing your product candidate in a rapid or accelerated manner
and/or mitigate risk of
unsuccessful clinical trials, as such statements are speculative and
suggest that investors
are afforded protection from loss.
6. Please provide the basis for your statements that all of your product
candidates target
multi-billion-dollar commercial markets, which you believe, to date,
are unsatisfied.
Our Management Team, Executive Chair, Advisors and Investors, page 3
7. Please limit the identification of investors in your summary and the
discussion of "Our
Management Team, Executive Chair, Advisors and Investors" beginning on
page 100 to
investors identified in your Principal Stockholders table on page 159.
You may identify
additional investors following the Principal Stockholders table with
accompanying
disclosure indicating any plans to update investors about any changes
these entities make
with respect to their investments in your company.
Prospectus Summary
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 5
Raju Mohan, PhD
FirstName LastNameRaju
Ventyx Biosciences, Inc. Mohan, PhD
Comapany 18,
September NameVentyx
2021 Biosciences, Inc.
September
Page 3 18, 2021 Page 3
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8. Here and in a risk factor at page 68, 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 disclosure on page 96
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 amended and restated bylaws provide that the Court of Chancery of the State
of Delaware
and the federal district courts, page 67
9. Please revise your risk factor to disclose that there is also a risk
that your exclusive forum
provision may result in increased costs for investors to bring a
claim.
Market, Industry and Other Data, page 75
10. Your statements that: (i) investors are cautioned not to give undue
weight to third party
estimates, (ii) you have not independently verified any third-party
information, and (ii)
such third party information is inherently imprecise may imply an
inappropriate
disclaimer of responsibility with respect to the third party
information. Please either delete
these statements or specifically state that you are liable for such
information.
Dilution, page 80
11. With reference to your historical financial statements, please address
the appropriateness
of your referenced $(87.3) historical net tangible book value
(deficit) as of June 30, 2021.
Research and Development Support Services with Bayside Pharma, LLC, page 87
12. Please file your agreement with Bayside Pharma LLC as an exhibit to
your registrations
statement or provide us with your analysis supporting your
determination that it is not
required to be filed.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development, page 89
13. Please disclose the costs incurred during each period presented for
each of your key
research and development projects. If you do not track your research
and
development costs by project, please disclose that fact and explain
why you do not
maintain and evaluate research and development costs by project.
Provide other
quantitative or qualitative disclosure that provides more transparency
as to the type
of research and development expenses incurred (i.e. by nature or type
of expense) which
should reconcile to total research and development expense on the
Consolidated
Statements of Operations.
Critical Accounting Policies and Significant Judgments and Estimates
Raju Mohan, PhD
FirstName LastNameRaju
Ventyx Biosciences, Inc. Mohan, PhD
Comapany 18,
September NameVentyx
2021 Biosciences, Inc.
September
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Stock-Based Compensation Expense, page 94
14. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances, including stock
compensation. Please
discuss with the staff how to submit your response.
Our Strategy, page 101
15. We note your disclosure that "all of [y]our pipeline candidates have
been internally
discovered and developed." Please revise to clarify that you purchased
all intellectual
property related to inhibition of TYK2 from Vimalan Biosciences, that
VTX002 was
discovered and partially developed by Oppilan and VTX2735 discovered
and partially
developed by Zomagen prior to your acquisition of these companies.
Figure 2: Potential indications for TYK2-targeted molecules, page 103
16. Please revise your disclosure to clarify the commercial opportunity
for your product
candidate related to the indication that you are currently pursuing.
Indicate that the
commercial opportunity with respect to the other indications will
require additional
clinical trials.
Rationale for Targeting TYK2, page 105
17. We note that Table 1 on page 107 compares PASI scores from various
clinical trials. To
the extent the data in Table 1 on page 107 was not compiled based on
head to head
studies, please revise your disclosure to eliminate the comparison.
Summary of VTX958 Preclinical Data, page 110
18. Please revise your statement on page 110 that "VTX958 can be dosed
safely across the
expected therapeutic range in humans" and your disclosure on page 120
that VTX2735
had an "attractive in vivo/in vitro safety profile" to avoid the
implication that your product
candidate is safe, as that determination is solely within the
authority of the FDA and
comparable regulatory bodies. We will not object to statements that
your product
candidate was well-tolerated in pre-clinical studies.
Overview of the IBD Market Opportunity, page 111
19. We note your disclosure that in 2020, the IBD market was approximately
$14 billion in
the U.S. and $20 billion globally, with the UC segment representing
approximately $7
billion in 2020 sales. Please revise to clarify if these figures
represent the market
opportunity associated with patients that have moderate-to-severe
disease, which appears
to be the target population for VTX002. Please also clarify if the UC
segment relates to to
Raju Mohan, PhD
FirstName LastNameRaju
Ventyx Biosciences, Inc. Mohan, PhD
Comapany 18,
September NameVentyx
2021 Biosciences, Inc.
September
Page 5 18, 2021 Page 5
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the U.S. or global market.
Intellectual Property, page 123
20. Please revise to specify the jurisdictions associated with your
foreign patent and patent
applications for each product candidate.
Management, page 136
21. We note your disclosure that in addition to Ventyx, your founder and
CEO, Raju Mohan,
is also the founder of multiple start-up biopharmaceutical companies.
Based on each
company's website, it appears that Mr. Mohan is also a Partner and
Senior Advisor at New
Science Ventures and that Messrs. Mohan, Krueger and Nuss serve as
officers of Escalier
Biosciences. Accordingly, please disclose these positions in the
applicable descriptions of
these individuals' business backgrounds as required by Item 401(e) of
Regulation S-K.
Additionally, clarify the amount of time that your executive officers
expect to devote to
Ventyx Biosciences andconsider including risk factor disclosure that
addresses limitations
on the time and attention each officer is able to devote to the
company and possible
conflicts of interest faced by your officers as a result of their
outside activities, in each
case to the extent they pose significant risks to the Company.
Certain Relationships and Related Party Transactions, page 155
22. Please revise your disclosure to provide the information required
under Item 404(a) of
Regulation S-K with respect to each of the Vimalan Asset Purchase
Agreement, Kalika
Employment Arrangement, Oppilan Share Acquisition Agreement and
Zomagen Share
Acquisition Agreement. For example, please disclose the the
approximate dollar value of
the amount involved in each transaction. Please also file the Oppilan
Pharma and
Zomagen Biosciences purchase agreements as exhibits to your
registration statement.
Alternatively, please explain to us why such disclosure is not
required.
Anti-Takeover Effects of Delaware Law and Our Certificate of Incorporation and
Bylaws, page
163
23. Please revise to clarify whether your exclusive forum provision
applies to actions arising
under the Exchange Act.
Consolidated Financial Statements of Ventyx Biosciences, Inc.
Note 5. Acquisitions, page F-20
24. Please break out the material components of the net assets
(liabilities) acquired. Also,
although we note that the Company is still finalizing the allocation
of the purchase price,
please expand your disclosures to address whether you may recognize
additional
identifiable assets acquired or liabilities assumed such as patents,
contracts that are not at
market, assembled workforce, etc.or any other incremental information
that would
enable users of your financial statements to evaluate the nature and
financial effect of your
Raju Mohan, PhD
Ventyx Biosciences, Inc.
September 18, 2021
Page 6
acquisitions as required by ASC 805-10-50-1, including your
determination to account
these acquisitions as asset acquisition.
25. Please disclose the fair value of your common stock, Series A-1
preferred stock and
options to purchase shares of Ventyx common stock. With reference to
the specific terms
of each security, explain why, as disclosed on page F-93, you have
valued both your
common stock and Series A-1 at $.32 per share.
Unaudited Pro Forma Condensed Combined Financial Information
Note 4. Transaction Accounting Adjustments, page F-94
26. We note that you identify pro forma adjustments C, D, G, H and I as
nonrecurring items.
Please explain to us why these adjustments are appropriate and meet
the requirements for
pro forma presentation under Article 11 of Regulation S-X, as amended
by SEC Release
No. 33-10786. In this regard, we note that these expenses are included
in your underlying
historical financial statements and do not appear to be directly
affected by the
Acquisition. Address this comment as it relates to adjustments E and
J. Please advise or
revise your pro forma financial information accordingly
General
27. Please 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 Li Xiao at 202-551-4391 or Jeanne Baker at 202-551-3691
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 LastNameRaju Mohan, PhD Sincerely,
Comapany NameVentyx Biosciences, Inc.
Division of
Corporation Finance
September 18, 2021 Page 6 Office of Life
Sciences
FirstName LastName