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United States securities and exchange commission logo
June 24, 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.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted June 12,
2020
CIK No. 0001810182
Dear Dr. Pons:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary, page 1
1. We note your revisions
in response to prior comment 1; however, you continue to make
reference throughout
your filing to "promising clinical data" and "promising levels of anti-
tumor activity." As
safety and efficacy determinations are solely within the FDA's
authority and they
continue to be evaluated throughout all phases of clinical trials, please
remove these
references. In the Business section, you may present objective data resulting
from your trials
without including conclusions related to efficacy.
Jaume Pons, Ph.D.
FirstName LastNameJaume Pons, Ph.D.
ALX Oncology Holdings Inc.
Comapany NameALX Oncology Holdings Inc.
June 24, 2020
Page 2
June 24, 2020 Page 2
FirstName LastName
Pipeline, page 2
2. We note your response to prior comment 3 that you have not shortened
the arrows
representing progress in Phase 1 trials for ALX148 in combination with
pembrolizumab
and trastuzumab for solid tumor indications. It appears from the
narrative description of
combination trials on pages 104-108 that Phase 1 trials are ongoing.
Please revise the
tabular or narrative description, as appropriate, to clarify the
precise status of the
combination trials, or explain why the arrows in this section of the
pipeline chart
appropriately reflect the status of combination Phase 1 trials as
completed.
Our Strategy, page 3
3. We note your revised disclosure in response to our prior comment 4.
Please revise to
make it clear here and in the Business section that there can be no
assurance that your
intended approach to leverage data from ALX148 trials in one
indication will be sufficient
for accelerated approval of ALX148 in other indications.
License and Collaboration Agreements, page 82
4. We note your response to our prior comment 7 regarding 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. Material information
must be
disclosed, even if that information could be considered commercially
sensitive.
Accordingly, please revise to provide the aggregate future milestone
payments for each
agreement.
Financial Statements
Consolidated Balance Sheets as of December 31, 2018 and 2019, page F-6
5. Please revise to remove your pro forma shareholders' equity as of
December 31, 2019.
Refer to Rule 11-02(c)(1) of Regulation S-X.
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,
Division of
Corporation Finance
Office of Life
Sciences
cc: Michael E. Coke, Esq.