United States securities and exchange commission logo
October 14, 2021
Steve R. Carchedi
Chief Executive Officer
Allarity Therapeutics, Inc.
210 Broadway, Suite 201
Cambridge, MA 02139
Re: Allarity
Therapeutics, Inc.
Amendment No. 1 to
Registration Statement on Form S-4
Filed September 29,
2021
File No. 333-259484
Dear Mr. Carchedi:
We have reviewed your amended 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 amending your registration
statement and providing the
requested information. 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 any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Unless we note
otherwise, our references to prior comments are to comments in our
September 20, 2021 letter.
Amendment No. 1 to Registration Statement on Form S-4
Summary of Information Statement/Prospectus
The pursuit of clinical stage assets, page 13
1. We note your response
to prior comment 8. You continue to state that you strive to
identify and pursue
novel oncology therapeutic candidates that have advanced beyond
Phase 1 clinical trials
that demonstrated the candidate is well tolerated by the tested
patient population, and
are preferably Phase 2 or Phase 3 clinical stage, having previously
shown signs of
anti-cancer activity in patients. You may explain your strategy but may
not imply that any of
your product candidates have been demonstrated to be effective.
Please revise your
disclosure accordingly. Please revise similar disclosure throughout your
registration statement
that presents your conclusions regarding efficacy, e.g., your
Steve R. Carchedi
FirstName LastNameSteve
Allarity Therapeutics, Inc. R. Carchedi
Comapany
October 14,NameAllarity
2021 Therapeutics, Inc.
October
Page 2 14, 2021 Page 2
FirstName LastName
statement on page 116 that dovitinib has shown promising anti-tumor
activity
Our Pipeline of Therapeutic Candidates, page 14
2. We note your response to our prior comment 10 and reissue the comment
in part. Please
revise the column heading "Phase 1/2" to reflect "Phase 1."
Risk Factors
General Risk Factors Related to Owning our Common Stock and this Offering, page
74
3. We note your response to our prior comment 14 and reissue the comment.
Please revise
this section to relocate any generic risk factors you present to the
end of the section under
the caption "General Risk Factors." For example, but without
limitation, risks related to
business interruptions or to your internal computer systems could
apply to nearly any
issuer in your industry and even in other industries. Refer to Item
105(a) of Regulation S-
K.
Our Certificate of Incorporation designates the Court of Chancery of the State
of Delaware, page
80
4. We note your response to our prior comment 15 and reissue the comment
in part. Your
current bylaws, filed as exhibit 3.2, state on page 26 that the
exclusive forum provision
does not apply to actions arising under the Securities Act of 1933,
but is silent as to
whether it applies to actions arising under the Exchange Act. If this
provision does not
apply to actions arising under the Exchange Act, please also ensure
that the exclusive
forum provision in the governing document states this clearly.
Material U.S. Federal Income Tax Consequences of the Recapitalization Share
Exchange as a
Tax-Free Reorganization, page 87
5. We note your response to prior comment 16. Please revise Exhibit 8.1
to state clearly that
the disclosure in the tax consequences section is the opinion of
counsel. It is not sufficient
to opine on the manner in which the material tax consequences are
described in the
prospectus. Refer to Sections III.B. 2 and C.2 of Staff Legal Bulletin
No. 19.
Allarity's Business
Priority Therapeutic Programs, page 112
6. We note your response to our prior comment 20 and we reissue our
comment. For each of
your priority assets that are former drug candidates of large
pharmaceutical companies,
please include in your description of the pre-clinical and clinical
trials for those candidates
a discussion of any failures in past clinical studies and why those
studies may have been
stopped or abandoned. For example, please revise the descriptions of
prior clinical studies
related to dovitinib, specifically for A2107 and A2302 on pages 116
and 117, that do not
appear to include a clear indication of why these studies were
abandoned by Novartis.
Similarly, please revise your disclosure on page 135 with respect to
prior clinical trials of
Steve R. Carchedi
FirstName LastNameSteve
Allarity Therapeutics, Inc. R. Carchedi
Comapany
October 14,NameAllarity
2021 Therapeutics, Inc.
October
Page 3 14, 2021 Page 3
FirstName LastName
stenoparib that currently states that "[f]urther clinical evaluation
was stopped, as it was
decided to stop the clinical development" to clarify why any prior
clinical trials had failed
and why the clinical evaluation was abandoned.
Intellectual Property, page 179
7. We note your response to our prior comment 23 and reissue the comment
in part. Please
revise this section to segregate patents that are owned and patents
that are in-licensed.
Additionally, please add disclosure for patents related to LiPlaCis
and 2X-111, as you
have done for your other material assets. Please also disclose the
specific key foreign
jurisdictions in which you are pursing patent applications for your
ixabepilone patent
portfolio.
License Agreement with Novartis Pharma for Dovitinib, page 180
8. We note your response to prior comment 25 and we reissue in part. We
note your
references to a very low double digit percentage, slightly
higher double digit
percentage and slightly lower mid-level double digit percentage.
Please revise this
section to disclose the applicable royalty rate or range not to exceed
ten percentage points
per tier. Please make similar revisions to the description of your
royalty obligations under
your license agreement with Eisai and under your development, option
and license
agreement with R-Pharm.
Please also add disclosure in the Summary and under an appropriate
heading in the Risk
Factors section discussing the extent to which you in-license the
intellectual property
related to assets dovitinib and stenoparib.
9. Please expand your disclosure to describe all material terms of your
license agreements
with LiPlasome and 2-BBB Medicines BV, which are filed as exhibits
10.3 and 10.4,
including:
description and quantification of the benefits and obligations
under the agreement,
quantification of all payments made to date,
disclosure of the aggregate amount of all potential development,
regulatory and
commercial milestone payments,
quantification of the royalty rate, or a range no greater than 10
percentage points per
tier, and
term and termination provisions.
Research and Development Expenses, page 222
10. Please tell us how patent costs meet the definition of research and
development expenses
in ASC 730-10 as these costs appear to be the same or similar to
activities described
in ASC 730-10-55-2i, which are not generally considered research and
development.
Steve R. Carchedi
Allarity Therapeutics, Inc.
October 14, 2021
Page 4
Item 21. Exhibits and Financial Statement Schedules, page II-2
11. We note that the exhibits for your first and second amendments to your
license agreement
with Eisai appear to be switched such that the file corresponding to
exhibit 10.11 is the
second amendment rather than the first amendment as listed here. Please
refile these
exhibits to correspond with the exhibit numbers provided in the list of
exhibits.
You may contact Nudrat Salik at (202) 551-3692 or Vanessa Robertson at
(202) 551-
3649 if you have questions regarding comments on the financial statements and
related
matters. Please contact Jessica Ansart at (202) 551-4511 or Christine Westbrook
at (202) 551-
5019 with any other questions.
Sincerely,
FirstName LastNameSteve R. Carchedi
Division of
Corporation Finance
Comapany NameAllarity Therapeutics, Inc.
Office of Life
Sciences
October 14, 2021 Page 4
cc: Scott E. Bartel, Esq.
FirstName LastName