United States securities and exchange commission logo
September 20, 2021
Steve R. Carchedi
Chief Executive Officer
Allarity Therapeutics, Inc.
210 Broadway, Suite 201
Cambridge, MA 02139
Re: Allarity
Therapeutics, Inc.
Registration
Statement on Form S-4
Filed August 20,
2021
File No. 333-258968
Dear Mr. Carchedi:
We have reviewed your 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.
Registration Statement on Form S-4 filed August 20, 2021
Cautionary Note Regarding Forward-Looking Statements; Market, Ranking
and Other Industry
Data, page 3
1. We note your statement
here that "investors are cautioned not to unduly rely upon [your]
statements" reflecting
your beliefs and opinions on the relevant subject that are based on
information available
to you as of the date of the information statement. We also note
your disclosure in a
risk factor on page 62 that while you believe you have obtained
statistical data,
market data and other industry data and forecasts used throughout the
information statement
from market research, publicly available information and industry
publications believed
to be reliable, no third-party has verified such research. These
statements appear to
imply a disclaimer of responsibility for this information in the
prospectus. Please
either delete these statements or specifically state that you are liable for
Steve R. Carchedi
FirstName LastNameSteve
Allarity Therapeutics, Inc. R. Carchedi
Comapany 20,
September NameAllarity
2021 Therapeutics, Inc.
September
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the information related to the market and industry data.
Summary of Information Statement/Prospectus, page 12
2. The disclosure in the summary should be a balanced presentation of
your business. Please
balance the description of your strengths with equally prominent
disclosure of the
challenges you face and the risks and limitations that could harm your
business or inhibit
your strategic plans. For example, but without limitation, balance
your discussion of
your plans for the clinical development of your product candidates
along with your
companion DRP diagnostics with a discussion of the failures of those
product candidates
in previous clinical trials and the challenges you may face in
obtaining regulatory
approval to market a companion diagnostic.
3. We note that on pages 26 and 218 you state there is an indication that
substantial doubt
exists related to your ability to continue as a going concern. Please
expand your disclosure
in the Summary to include this information and disclose your history
of net losses and
provide your accumulated deficit as of the most recent balance sheet
date.
4. You state on page 12 and elsewhere throughout the prospectus that you
are "pursu[ing]
oncology therapeutic candidates that have been "de-risked through
substantiated prior
clinical trials by other pharmaceutical companies." However, in a risk
factor on page 34,
you state that these candidates have failed therapeutic clinical trial
endpoints in Phase 2 or
later clinical trials and that "[p]otential out-licensees, alliance
partners and collaborators
may view a therapeutic candidate identified with our proprietary DRP
companion
diagnostics platform with more skepticism because of its history of
failed clinical trials
[...]." Given the uncertainty of developing product candidates through
clinical trials and
commercialization, it is inappropriate to state or imply that you have
mitigated or will
mitigate development risk. Accordingly, please remove the references
to your product
candidates as "de-risked" throughout your registration statement.
5. We note your disclosure that you believe you "will be able to realize
the promise of
personalized medicine by selecting the patients most likely to benefit
from each of our
therapeutic candidates, thereby increasing the likelihood of clinical
success." Please
revise disclosure here and elsewhere in the prospectus as appropriate
to remove references
to "realizing the promise of personalized medicine" and to "increasing
the likelihood of
clinical success" as these statements are speculative in light of the
regulatory status of the
product candidates you are currently pursuing. As an example only, we
note your
disclosure on page 14 that your DRP may substantially improve the
overall treatment
response in your clinical trials and increase the likelihood for
regulatory approval to
market your therapeutic candidates while potentially reducing the
time, cost and risk of
clinical development.
6. We note your statement here that "[you] may additionally conduct a
near-term clinical
trial for stenoparib to test the anti-viral activity of this
therapeutic candidate as a potential
treatment for SARS-CoV-2 (COVID-19) applications." We also not your
statement on
Steve R. Carchedi
FirstName LastNameSteve
Allarity Therapeutics, Inc. R. Carchedi
Comapany 20,
September NameAllarity
2021 Therapeutics, Inc.
September
Page 3 20, 2021 Page 3
FirstName LastName
page 14 that you believe that your DRP-guided clinical programs "may
potentially be
considered for the FDA's accelerated approval process." Please revise
your disclosure on
page 12 as well as similar disclosure on page 102 to clarify that
while you have submitted
a phase 2/3 protocol through the BARDA portal to be an arm in the NIH
clinical trials,
you have not yet submitted an IND to the FDA and there is no guarantee
that you will
become a participant in the NIH clinical trials or that the FDA will
grant you an IND to
commence a clinical trial to test the anti-viral activity of
stenoparib as a potential
treatment for COVID-19 applications. Please also revise your
disclosure on page 14 to
clarify that you have not submitted an application for the FDA's
accelerated approval
process and that there is no guarantee that the FDA will grant you
approval. Please also
revise to affirmatively state that the FDA's accelerated approval
pathways do not
guarantee an accelerated review by the FDA.
7. We note your statement on page 13 and throughout the prospectus that
the DRP platform
has been "retrospectively validated in 35 clinical trials." Please
revise your disclosure
here to explain what you mean by "retrospectively validated" and also
to clarify that you
have not yet received approval from the FDA or other regulatory agency
to market a
companion diagnostic and you will need this approval in order to
market any of your
therapeutic candidates. Please also explain whether you expect to be
able to rely on your
"retrospective" analyses in support of your application for pre-market
approval of your
companion diagnostics.
8. We note your statement that your product candidates have shown
"promising signs of
anti-tumor activity." Please revise this disclosure and similar
references to "encouraging
signs of anti-cancer effects" and "encouraging anti-tumor activity"
throughout your
prospectus that imply that your product candidates are effective as
such determinations are
made solely by the FDA and comparable foreign regulators.
9. We note your press release dated June 14, 2021 announcing that you
entered into binding
terms sheets for agreements under which Oncoheroes Biosciences, Inc.
will acquire
certain rights to dovitinib and stenoparib. Please revise your
disclosure to provide the
materials terms of the term sheets or tell us why you believe such
information is not
material.
Our Pipeline of Therapeutic Candidates, page 14
10. We note that you have included Irofulven in your pipeline table here
and on page 101.
Given that you suspended your study of Irofulven in 2019, that you
then sold Irofulven to
Lantern Pharma, Inc. in July 2021 and that you will no longer devote
any of your
development resources to this program, please remove this product
candidate from your
pipeline table or explain why the program is sufficiently material to
your business to
warrant its inclusion. Additionally, please revise the column heading
"Phase 1/2" to reflect
"Phase 1."
Steve R. Carchedi
FirstName LastNameSteve
Allarity Therapeutics, Inc. R. Carchedi
Comapany 20,
September NameAllarity
2021 Therapeutics, Inc.
September
Page 4 20, 2021 Page 4
FirstName LastName
Interests of Certain Persons in the Recapitalization Share Exchange, page 16
11. We note your disclosure here that "[c]ertain of Allarity A/S's
executive officers and
directors may have interests in the recapitalization share exchange
that may be different
from, or in addition to, the interests of Allarity A/S's shareholders"
and that "[t]he
members of the Allarity A/S board of directors were aware of and
considered these
interests, among other matters, when they approved the Reorganization
Agreement and
recommended that Allarity A/S shareholders approve the proposals
required to effect the
reorganization." Please revise to discuss how the board considered
those interests in
approving and recommending the reorganization.
Summary Historical Financial Information, page 22
12. Pursuant to Item 5 of the Form S-4, please provide pro forma financial
information which
gives effect to the Recapitalization Share Exchange Transactions as
well as the PIPE
Investment. Refer to Rule 8-05 of Regulation S-X.
Comparative Per Share Data, page 23
13. Please provide us with your calculations for the historical book value
per share for the six
months ended June 30, 2021 and June 30, 2021. It appears as though
these amounts would
not be negative since you had positive total equity.
Risk Factors, page 25
14. Please revise this section to relocate any generic risk factors you
present to the end of the
section under the caption "General Risk Factors." Refer to Item 105(a)
of Regulation S-K.
Our Certificate of Incorporation designates the Court of Chancery of the State
of Delaware, page
78
15. We note that your forum selection provision identifies a state court
located within the
State of Delaware (or, if the Court of Chancery does not have
jurisdiction, the federal
district court for the District of Delaware) as the exclusive forum
for certain litigation,
including any derivative action. We also note your disclosure on
page 244 that your
exclusive forum provision does not apply to claims under the federal
securities laws or
any other claim for which the federal courts have exclusive
jurisdiction. Please clarify in
this risk factor whether this provision applies to actions arising
under the Securities Act or
Exchange Act. If this provision does not apply to actions arising
under the Securities Act
or Exchange Act, please also ensure that the exclusive forum provision
in the governing
documents states this clearly.
Steve R. Carchedi
FirstName LastNameSteve
Allarity Therapeutics, Inc. R. Carchedi
Comapany 20,
September NameAllarity
2021 Therapeutics, Inc.
September
Page 5 20, 2021 Page 5
FirstName LastName
Material U.S. Federal Income Tax Consequences of the Recapitalization Share
Exchange as a
Tax-Free Reorganization, page 86
16. We note your disclosure on page 232 that it is intended that the
Reorganization Share
Exchange qualify as a reorganization within the meaning of
Section 368(a) of the Code.
Please revise your disclosure in this section to state that it is the
opinion of counsel, to
clearly identify and articulate the opinion being rendered and to
remove the language
stating that this section is a summary. Please ensure that you provide
a firm opinion for
each material tax consequence or explain why such an opinion cannot be
given. If the
opinion is subject to uncertainty, please provide an opinion that
reflects the degree of
uncertainty (ex: "should" or "more likely than not"). For guidance,
refer to Staff Legal
Bulletin No. 19, Sections III.C.1 and 4.
Information about Allarity A/S
Strategy, page 104
17. We note your reference to rapidly advancing the U.S. approval of
dovitinib. Please
revise this statement here and throughout your prospectus to remove
any implication that
you will be successful in commercializing your product candidates in a
rapid or
accelerated manner.
18. We note your statement on page 105 that "[t]he change of the U.S.
Presidential
administration in early 2021 may adversely impact [y]our participation
in Operation Warp
Speed." Please expand your disclosure to explain what you mean and the
basis for your
belief.
Companion Diagnostics, page 111
19. Your statement that your Dovitinib-DRP companion diagnostic is
"first-in-class" implies
the likelihood of regulatory approval and comparisons to other
companion diagnostics.
Please remove the "first-in-class" reference as the statement is
speculative in light of the
regulatory status of the companion diagnostic.
Priority Therapeutic Programs, page 111
20. 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.
21. To the extent not disclosed, please revise your discussion of the
preclinical and clinical
trials for each of your product candidates conducted to date to
specify the primary and
secondary endpoints of the different trials, the results as they
relate to the endpoints and
any statistical analysis that was done. Also add an explanation of how
statistical
significance relates to the approval process of the FDA and other
regulators. Additionally,
please ensure you disclose all serious adverse events (SAEs) and the
number of patients
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FirstName LastNameSteve
Allarity Therapeutics, Inc. R. Carchedi
Comapany 20,
September NameAllarity
2021 Therapeutics, Inc.
September
Page 6 20, 2021 Page 6
FirstName LastName
who experienced them for SAEs that were determined to be
treatment-related or that the
investigator could not determine were not treatment related.
Anticipated NDA Filing for RCC, page 121
22. We note your disclosure here that you anticipate submitted an NDA
filing for dovitinib for
the treatment of advanced RCC and that the NDA will be supported
primarily by data
from one randomized Phase 3 trial (A2302) and from one Phase 1/2 trial
(A2107). Please
expand your descriptions of these trials starting on page 115 to
clearly identify and
explain the data from each trial that will be used to support your NDA
filing. In
particular, we note your statement regarding the Phase 3 trial (A2303)
that "[t]he trial
failed its primary anti-cancer activity endpoint [...]." Please
clarify whether other trial
endpoints were met and explain the impact of the trial's failure to
meet this endpoint.
Intellectual Property, page 172
23. Please revise to disclose for each material patent and patent
application the specific
products or diagnostics to which such patents or patent applications
relate, whether the
patents are owned or licensed, the type of patent protection, the
expiration dates, and
applicable material jurisdictions, including any foreign jurisdiction.
Consider disclosure in
tabular format by patent family or otherwise in addition to the
narrative provided.
24. We note your disclosure that certain patents covering your portfolio
assets and that certain
patents that may issue in the future from your pending patent
applications have or are
projected to have expiration dates in 2021. Please revise to disclose
what effect you
expect the expiration of these patents to have on your patent
portfolio and your business
and if you intend to take any action to mitigate such effect.
License Agreement with Novartis Pharma for Dovitinib, page 174
25. We note your disclosure on pages 174 through 178 outlining your
various license and
development agreements. For each agreement, please expand your
disclosure to describe
all material terms of the agreement including:
any upfront or execution payments received or paid;
quantification of all milestone payments received or paid to date;
and
quantification of the royalty rate, or a range no greater than 10
percentage points per
tier.
Please also expand your description of the out-license agreement with
SMERUD to
specify, in addition to the above terms, the duration of the agreement
and the royalty term
as well as the termination provision.
Please also add disclosure in the Summary and under an appropriate
heading in the Risk
Factors section discussing your dependence on these agreements in
order to develop
dovitinib and stenoparib.
Steve R. Carchedi
FirstName LastNameSteve
Allarity Therapeutics, Inc. R. Carchedi
Comapany 20,
September NameAllarity
2021 Therapeutics, Inc.
September
Page 7 20, 2021 Page 7
FirstName LastName
Research and Development Expenses, page 215
26. Please disclose your research and development expenses by product
candidate for each
period presented. To the extent that you do not track expenses by
product candidate,
please disclose as such, and provide a breakdown by nature of type of
expense.
Accounting Treatment of the Recapitalization Share Exchange, page 229
27. Please also address your planned accounting of the PIPE Investment
Agreement,
specifically how you intend to account for the shares of preferred
shares that will be
issued.
The Reorganization Agreement
Conditions to Closing, page 236
28. Please clarify which conditions are subject to waiver.
2. Summary of Significant Accounting Policies
(m) Acquired In-Process Research and Development (IPR&D), page F-12
29. Your disclosures on page F-30 indicate that you in-licensed the
exclusive worldwide
rights to both Stenoparib and Dovitinib rather than acquiring as part
of a business
combination. In this regard please address the following:
Given that these two amounts represent your entire IPR&D assets
recorded at
December 31, 2020, please expand your accounting policy
disclosures to also address
IPR&D assets not acquired in a business combination; and
Please help us understand how you determined these should be
recorded as
indefinite-lived intangible assets pursuant to ASC 350. Please
include your
consideration of ASC 730-10-25-2(c) and how you determined there
is alternative
future use.
Condensed Consolidated Balance Sheets (Unaudited), page F-40
30. Please disclose what the obligation to issue shares represents on your
balance sheet as of
June 30, 2021.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited), page
F-41
31. Please provide us with the calculation for the basic and diluted net
loss per common share
of $ (0.01) as it appears the amount should be $ (0.02) as disclosed
on pages 23 and F-55.
General
32. We note that you refer to your document throughout as an "information
statement" and
further note your disclosure on page 84 that Allarity A/S is
soliciting votes for the
approval of the proposals in accordance with Danish law. Please tell
us why you refer to
Steve R. Carchedi
Allarity Therapeutics, Inc.
September 20, 2021
Page 8
your document as an "information statement" given that you are
soliciting proxies for the
extraordinary general meeting.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
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
September 20, 2021 Page 8
cc: Scott E. Bartel, Esq.
FirstName LastName