United States securities and exchange commission logo
April 8, 2021
Keeren Shah
Finance Director
AccuStem Sciences Ltd
107 Cheapside
9th Floor
London EC2V 6DN United Kingdom
Re: AccuStem Sciences
Ltd
Registration
Statement on Form 20-F
Filed March 12,
2021
File No. 000-56257
Dear Ms. Shah:
We have reviewed your filing 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 these comments within ten business days by
providing the requested
information or advise us as soon as possible when you will respond. If
you do not believe our
comments apply to your facts and circumstances, please tell us why in
your response.
After reviewing your response and any amendment you may file in
response to these
comments, we may have additional comments.
Registration Statement on Form 20-F
Introduction, page 1
1. We note that Tiziana
Life Sciences conducted a demerger and spin off on October 30,
2020. Please tell us
the exemption relied upon for the distribution of Accustem shares and
provide an analysis
relating to the availability of such exemption.
Item 3. Key Information
D. Risk Factors
There are risks associated with the process of establishing a U.S.
Clinical Laboratory
Improvement Amendment of 1988..., page 11
2. We not your statements
that your products do not as yet have status as LDTs and you do
Keeren Shah
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not yet have a CLIA-certified laboratory. Please revise to remove the
implication that you
will obtain these require FDA clearance and certification,
respectively, and obtaining such
is not guaranteed.
Item 4. Information on the Company, page 30
3. We note certain statements implying efficacy in the History and
Development of the
Company and Business Overview sections, such as "Stem PrintER showed
superiority to
Oncotype DX in predicting recurrence in ER+/HER2- postmenopausal
breast cancer
patients" and "favorable results showed superior performance of
StemPrimerER over
Oncotype DX." Efficacy determinations are the exclusive authority of
the FDA or
comparable foreign regulators. Please replace all claims or
conclusions related to efficacy
with a description of the objective data resulting from the trials.
With respect to the head
to head trials with Oncotype DX, you may compare the objective results
of the two trials
without concluding the trials demonstrated your candidate is
"superior."
Business Overview, page 31
4. We note your disclosure in the risk factors on pages 12 and 13
regarding your owned
patents, your licensed patents from the University of Milan and your
licensed patent
applications. With respect to your material patents and patent
applications, please revise
this section to disclose the specific products, product groups and
technologies to which
such patents or patent applications relate, whether they are owned or
licensed, the type of
patent protection that you have (composition of matter, use or
process), the expiration
dates, the applicable jurisdictions and whether there are any
contested proceedings or
third-party claims. Refer to Item 4.B.6 of Form 20-F.
Operating and Financial Review and Prospects, page 41
5. Revise to separately quantify the research and development expenses
recorded by the
registrant during the period presented for each major product
candidate or program area of
research. Separately revise this section or your Business section as
applicable to discuss
the general historic trends in research and development costs
experienced under the
predecessor's oversight, and discuss the extent to which you expect
those trends to
continue or to diverge after the demerger. For example, the table on
page 70 of Tiziana's
Form 20-F for the year ended December 31, 2019 appears to show
research expense for
StemPrintER declining significantly for the last three years
presented.
License, page 43
6. Please revise discussion of the license agreement(s) to disclose the
duration of agreement,
the royalty term, the termination provisions, and the following
payment provisions:
Aggregate future potential milestone payments;
Royalty rates;
Royalty term; and
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Comapany
April NameAccuStem Sciences Ltd
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Remaining diligence milestones to the extent that the failure
to meet them may allow
IEO/University of Milan to terminate the agreement.
B. Compensation
Consultancy Agreement, page 49
7. Please file your agreement with Keeren Shah as an exhibit to the
registration statement.
Major Shareholders and Related Party Transactions, page 52
8. Please revise your disclosure to identify the natural person or
persons who have voting
and investment control of the shares held by Planwise Group Limited.
Financial Statements, page F-1
9. Given that you are an emerging growth company, Item 8 of the Form 20-F
indicates that
you are required to two complete years of financial statements.
Instruction 1 to Item 8
also indicates that in some cases you may have to provide financial
statements for a
predecessor and refers to the definition of a predecessor in
Exchange Act Rule 12b-
2 and Securities Act Rule 405. Although we note that the registrant in
its new legal
form, Accusystem Sciences Limited, did not exist until it was
incorporated on June 5,
2020, please tell us what consideration you gave to providing
predecessor financial
statements related to the operating business transferred, including
for the year ended
December 31, 2019 and for the period prior to the demerger transaction
in 2020. Further,
you disclose that the acquisition has been treated as a common control
combination.
Clearly address how you considered your use of the common control
methodology in
determining whether and how to present the financial statements of the
historical
operating business.
10. Please provide robust disclosure regarding how the financial
statements of the underlying
business were prepared, including the accounting policy used to
prepare these financial
statements and how you determined this accounting policy to be
reliable pursuant to IAS
8.10.b. Please specifically address the following:
Please better clarify in your disclosures how it was determined
which assets,
liabilities, and operations should be included in the financial
statements;
Please clearly disclose, if true, that the financial statements
provided reflect all of the
costs of doing business related to StemPrintER and SPARE
operations, including
expenses incurred by other entities on your behalf. Please
disclose management s
estimates of what the expenses would have been on a stand-alone
basis, if
practicable. We note your risk factor disclosure on page 17 which
indicates that
Tiziana Life Sciences plc performed various corporate functions
for you and that
your historical financial results reflect corporate expenses for
such functions that are
likely to be less than the expenses you would have incurred had
you operated as a
separate company;
Keeren Shah
FirstName LastNameKeeren Shah
AccuStem Sciences Ltd
Comapany
April NameAccuStem Sciences Ltd
8, 2021
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Please specifically disclose the allocation method used for
each material type of
expense allocated in the financial statements provided; and
Please expand your disclosures to provide an analysis of the
intercompany accounts
with Tiziana Life Sciences plc.
Notes to Consolidated Financial Statements, page F-7
11. In regards to the license agreement with IEO/University of Milan,
which has been
assigned to you as discussed on page 43, please disclose all material
terms of the license
agreement, including aggregate potential milestone payments, royalty
term, term of the
agreement and termination provisions.
Note 4. Acquisition of a Subsidiary, page F-10
12. Please provide robust disclosure regarding the accounting policy used
to account for this
common control transaction with Tiziana Life Sciences plc. As part of
your response,
please address the following:
Disclose briefly and tell us in detail how you determined this
accounting policy to be
relevant and reliable pursuant to IAS 8.
Revise to specifically address the conclusion to record the
initial distribution at fair
value.
Provide transparent disclosure of what your equity line item title
"merger reserve"
represents and how it was calculated as part of this transaction.
Your disclosure here on F-8 as well as on page F-10 states that
the business asset did
not exist until the statutory demerger and did not exist in prior
years. Please revise to
address the apparent inconsistencies between these statements and
the disclosure that
Tiziana acquired the license for the underlying technology in
2014, as well as the
disclosures elsewhere in your filing and Tiziana's filings about
the prior activities of
this business.
Note 5. Intangible Assets, page F-11
13. We note that you recorded an indefinite lived IPR&D intangible asset
in connection with
the transaction with Tiziana Life Sciences plc. Pursuant to IAS 38,
please address the
following:
How you determined it was appropriate to record an intangible
asset, specifically
given your determination to account for the transaction as a
transfer under common
control;
How the intangible asset is defined, including descriptions of the
underlying licenses
and technology;
How you determined the appropriate value of the intangible asset;
and
How you determined the intangible asset should have an indefinite
life.
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
Keeren Shah
AccuStem Sciences Ltd
April 8, 2021
Page 5
action by the staff.
You may contact Nudrat Salik at 202-551-3692 or Kevin Vaughn at
202-551-3494 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jordan Metoyer at 202-551-6001 or Suzanne Hayes at 202-551-3675 with
any other
questions.
Sincerely,
FirstName LastNameKeeren Shah
Division of Corporation
Finance
Comapany NameAccuStem Sciences Ltd
Office of Life Sciences
April 8, 2021 Page 5
cc: Jeffrey Fessler, Esq.
FirstName LastName