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United States securities and exchange commission logo
July 16, 2021
Lara Sullivan, M.D.
Chief Executive Officer
Pyxis Oncology, Inc.
35 CambridgePark Drive
Cambridge, MA 02140
Re: Pyxis Oncology,
Inc.
Draft Registration
Statement on Form S-1
Submitted June 21,
2021
CIK No. 0001782223
Dear Dr. Sullivan:
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 June 21, 2021
Prospectus Summary
Overview, page 1
1. Please revise this
opening paragraph to clarify that your operations are preclinical.
Our Portfolio, page 2
2. We note your product
pipeline tables here and in your Business section include "Multiple
mAb Programs" that are
in the discovery phase. Because you have not identified a product
candidate for these
programs, it appears premature to include them in a product pipeline
table. Please revise or
advise.
Lara Sullivan, M.D.
Pyxis Oncology, Inc.
July 16, 2021
Page 2
3. Please balance the disclosure in this section by noting, as disclosed
on page 103, that
"[d]espite the initial success seen by currently marketed products,
licensed ADCs still
have limitations that impact dosing, and are associated with
significant adverse events."
4. We note your disclosure here and throughout the draft registration
statement that your
preclinical models for your "next-generation" ADCs have demonstrated
"immunogenic cell death," "a validated anti-tumor effect,"
"significant anti-tumor
activity," "potent in-vivo activity," "potent anti-tumor activity,"
and that your "next-
generation" ADCs have potential greater therapeutic index and more
potent payloads than
"conventional ADCs." Please revise your disclosure to eliminate any
suggestion that your
product candidates have been or will ultimately be determined to be
safe or effective or to
have demonstrated efficacy for purposes of granting marketing approval
by the FDA or
comparable agency, including comparisons to the current standard of
care. In your
revised disclosure, please replace all claims or conclusions related
to efficacy with a
description of the objective data resulting from the preclinical
models.
Our Team and History, page 4
5. We note that you identify certain entities as investors in your
company; however, they do
not appear to be among your principal stockholders as disclosed on
page 169. If material,
please expand your disclosure to describe the nature of each named
entity's investment in
you and explain to us why including this information is appropriate.
Please also explain in
your response your plans to update investors about any changes these
entities make with
respect to their investments in the company.
Use of Proceeds, page 76
6. We note your disclosure that you intend to use a portion of the net
proceeds to fund the
development and regulatory activities relating to your product
candidates and discovery
programs. Please revise your disclosure to allocate the amount of
proceeds you expect to
use for each of your programs and specify how far in the clinical
development of your
product candidates you expect to reach with the net proceeds. If any
material amounts of
other funds are necessary to accomplish the specified purposes for
which the proceeds are
to be obtained, state the amounts and sources of such other funds
needed for each such
specified purpose and the sources thereof. Refer to Instruction 3 of
Item 504 of Regulation
S-K.
7. We note your disclosure that a milestone payment of $9.6 million will be
made to
LegoChem upon the earliest to occur of certain events, including the
date of pricing or
FirstName LastNameLara Sullivan, M.D.
offer of the first public offering of your common stock. We also note
that such payments
Comapany NamePyxis
are not reflected Oncology, Inc.Proceeds section. Please revise to
disclose the anticipated
in the Use of
July 16,source of such
2021 Page 2 funds or otherwise advise.
FirstName LastName
Lara Sullivan, M.D.
FirstName LastNameLara Sullivan, M.D.
Pyxis Oncology, Inc.
Comapany
July NamePyxis Oncology, Inc.
16, 2021
July 16,
Page 3 2021 Page 3
FirstName LastName
Dilution, page 80
8. Your disclosure states that historical net tangible book value
excludes preferred stock
which is not included within stockholders' equity (deficit).
Therefore, it appears that the
historical net tangible book value should be a deficit rather than
$6.3 million. Please
revise the calculation or advise as to the appropriateness of your
calculation.
Business
FACT Platform, page 104
9. We note your disclosure here that, "[r]ecent research has demonstrated
that site-specific
conjugation techniques enable enhanced pharmacologic properties and
homogenous DAR
and improved therapeutic index." Please revise your disclosure to
provide your basis for
this claim and include additional disclosure on the material details
of the "recent
research," including, for example only, the sponsor, type of study,
and trial design.
Pfizer optimized sites for linker-payload conjugation through empirical
research, page 105
10. We note your statements here that one of the FACT platform's
advantages is "[v]alidated
antibody-linker-payload combinations with optimized conjugation
sites." Please expand
your disclosure here to provide your basis for your belief that the
FACT platform
is "validated" given your current, preclinical stage of development of
your product
candidates.
Figure 9, page 107
11. We note your statement on the bottom of page 105 that, "the
therapeutic index of our
highly stable ADCs mitigated toxicity while maximizing PK exposure in
vivo." Please
revise your Figure 9 to clearly label PYX-201 ADC or otherwise revise
and clarify your
narrative disclosure to further explain your basis for this claim. In
addition, we note other
figures, such as Figure 13 and 14, where your product candidates are
not clearly labeled.
Please clarify your figure labels throughout your registration
statement as applicable.
Commercialization Plan, page 127
12. We note your disclosure here that you "retain full commercialization
rights for all our
product candidates, including those obtained through exclusive
collaboration agreements."
However, we note your disclosure elsewhere that you do not have the
rights to PYX-202
in South Korea. Please correct for this inconsistency or otherwise
advise.
Lara Sullivan, M.D.
FirstName LastNameLara Sullivan, M.D.
Pyxis Oncology, Inc.
Comapany
July NamePyxis Oncology, Inc.
16, 2021
July 16,
Page 4 2021 Page 4
FirstName LastName
Management
Executive Officers, page 149
13. We note several of your executive and director biographies where the
principal occupation
and employment is unclear during the past five years. Please discuss
the principal
occupation and employment for the past five years, including the name,
and principal
business of any corporation or other organization. See Item 401(e) of
Regulation S-K.
Employment Agreements, Severance and Change in Control Agreements
Robert Crane, page 161
14. We note your disclosure that Mr. Crane is entitled to an option upon
the closing of an
equity offering, non-dilutive collaboration transaction, convertible
debt or debt offering
resulting in gross proceeds to the Company of at least $20 million
and/or a change of
control of the Company. Please clarify your disclosure to state
whether or not Mr. Crane is
entitled to an option to purchase shares in connection with your
proposed initial public
offering.
Exhibits
15. Please file the joint venture agreement with Alloy Therapeutics, Inc.
as an exhibit to your
registration statement, or tell us why you believe you are not
required to do so. See Item
601(b)(10) of Regulation S-K.
You may contact Kristin Lochhead at 202-551-3664 or Vanessa Robertson
at 202-551-
3649 if you have questions regarding comments on the financial statements and
related
matters. Please contact Jason Drory at 202-551-8342 or Jeffrey Gabor at
202-551-2544 with any
other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Asher M. Rubin, Esq.