View:
United States securities and exchange commission logo
June 1, 2020
Jaume Pons, Ph.D.
Chief Executive Officer
ALX Oncology Holdings Inc.
866 Malcolm Road, Suite 100
Burlingame, California 94010
Re: ALX Oncology
Holdings Inc.
Draft Registration
Statement on Form S-1
Submitted May 5,
2020
CIK No. 0001810182
Dear Dr. Pons:
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, page 1
1. We note statements in
this section and in the Business section regarding the efficacy
and safety of your
product candidates. We further note statements that your product
candidates have
"demonstrated promising clinical activity" and "promising levels of
activity and safety."
Efficacy and safety are determinations that are solely within the
authority of the FDA or
similar foreign regulators. You may present clinical trial end
points and objective
data resulting from trials without concluding efficacy, and you may
state that your product
candidates are well tolerated if true. Please revise these statements
accordingly.
Jaume Pons, Ph.D.
FirstName LastNameJaume Pons, Ph.D.
ALX Oncology Holdings Inc.
Comapany NameALX Oncology Holdings Inc.
June 1, 2020
June 1, 2020 Page 2
Page 2
FirstName LastName
2. Please revise your statements here and elsewhere in the prospectus
that ALX148 has the
potential to become a "cornerstone" or "backbone" of future
combination treatments in
oncology. Please also revise your statements in the Business section
that ALX is a "first-
in-class" fusion protein and could become the cornerstone of a
"best-in-class" treatment
option. These statements imply an expectation of regulatory approval
and are
inappropriate given the length of time and uncertainty with respect to
securing marketing
approval.
Pipeline, page 2
3. It appears from your disclosure that the Phase 1 trials of ALX148 in
combination with
pembrolizumab, trastuzumab and rituximab are ongoing and have not been
completed.
Accordingly, please shorten the arrows in your pipeline table to
reflect the current stage of
development. Also, please clarify what you mean by "IND" in the first
column header.
For example, does this column reflect the completion of IND-enabling
studies, or the
submission of an IND?
Our Strategy, page 3
4. We note your disclosure that your strategy is to pursue "fast to
market trials" for ALX148.
Please revise this statement and any similar disclosure to remove any
implication that you
will be successful in commercializing your product candidates in a
rapid or accelerated
manner as such statements are speculative.
Risks Associated with Our Business, page 4
5. We note your disclosure that you will require substantial additional
capital to finance your
operations. Please revise to disclose that your current loan agreement
restricts your ability
to incur additional indebtedness without the consent of the lenders as
discussed on page
12.
Implications of Being an Emerging Growth Company, page 5
6. 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.
License and Collaboration Agreements, page 79
7. Please revise to disclose the aggregate future potential milestone
payments to be made for
the agreements with The Board of Trustees of the Leland Stanford
Junior University and
Selexis SA and when the royalty term is currently expected to expire
for all three of the
agreements in this section.
Jaume Pons, Ph.D.
FirstName LastNameJaume Pons, Ph.D.
ALX Oncology Holdings Inc.
Comapany NameALX Oncology Holdings Inc.
June 1, 2020
Page 3
June 1, 2020 Page 3
FirstName LastName
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock Based Compensation
Determination of the Fair Value of Common Stock, page 83
8. 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 most 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 and
beneficial conversion features.
CD47 Scientific Background, page 89
9. Please revise to indicate what NK-AML stands for in the chart on page
90.
Clinical Development of ALX148 in Hematologic Malignancies, page 97
10. We note the references to "response evaluable" subjects in this
section. Please disclose
the number of subjects in the trial where the response was not
evaluable and the reasons it
was not evaluable.
Licensing and Intellectual Property, page 104
11. With respect to your owned patents and patent applications, please
revise to specify the
product candidates or technologies to which such patents relate, the
type of patent
protection that you have, the expiration dates and the material
non-U.S. jurisdictions.
Please also specify the type of patent protection for the licensed
patents from Leland
Stanford Junior University.
12. We note your disclosure regarding a revoked European patent owned by
University
Health Network and The Hospital for Sick Children that may encompass
certain therapies
for the treatment of cancer using polypeptides comprising soluble
human SIRPa, or a
CD47-binding fragment thereof. Please revise to disclose what effect,
if any, you expect
this revoked European patent to have on your patent portfolio and your
business.
Non-Employee Directors, page 119
13. Please revise to ensure that you have disclosed the principal
occupations and employment
for Director Walmsley over the last five years. Refer to Item 401(e)
of Regulation S-K for
guidance.
Certain Relationships and Related-Party Transactions, page 132
14. Please file the agreements with venBio and Tollnine described in this
section as exhibits
to the registration statement, or tell us why you do not believe it is
required.
Jaume Pons, Ph.D.
ALX Oncology Holdings Inc.
June 1, 2020
Page 4
You may contact Christine Torney at 202-551-3652 or Lynn Dicker at
202-551-3616 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-3625
with any other
questions.
Sincerely,
FirstName LastNameJaume Pons, Ph.D.
Division of
Corporation Finance
Comapany NameALX Oncology Holdings Inc.
Office of Life
Sciences
June 1, 2020 Page 4
cc: Michael E. Coke, Esq.
FirstName LastName