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January 19, 2018
Tiziano Lazzaretti
Chief Financial Officer
Tiziana Life Sciences plc
3rd Floor, 11-12 St. James's Square
London SW1 4LB, United Kingdom
Re: Tiziana Life Sciences plc
Draft Registration Statement on Form 20-F
Submitted December 22, 2017
CIK No. 0001723069
Dear Mr. Lazzaretti:
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.
DRS Form 20-F submitted December 22, 2017
Item 4. Information on the Company
B. Business Overview
Overview, page 49
1. Please clarify the meaning of any scientific or technical terms the
first time they are used
in order to ensure that lay readers will understand the disclosure. For
example, please
briefly explain what you mean by "fully human monoclonal anti-CD3 mAB,"
"cyclin-
dependent kinases," "microRNAs," and "anti-IL6R mAB." Please also
explain briefly the
significance of Foralumab being a "fully human" monoclonal antibody, as
shown in the
Tiziano Lazzaretti
FirstName LastNameTiziano Lazzaretti
Tiziana Life Sciences plc
Comapany NameTiziana Life Sciences plc
January 19, 2018
June 16, 2017 Page 2
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graphic on page 52, the "Mayo Risk Score" referenced on page 54 and
the "Fc portion of
Foralumab" referenced on page 55.
2. Please revise your disclosure that states you acquired Milciclib from
Nerviano Medical
Sciences S.r.l. to clarify that you have in-licensed the intellectual
property relating to the
development of this product candidate.
3. The descriptions of our product candidates and the related clinical
trials include
numerous statements indicating that the candidates are safe and
effective. Please remove
all statements throughout your registration statement that present
your conclusions
regarding the safety or efficacy of your drug candidates as these
determinations are
within the authority of the U.S. Food and Drug Administration and
comparable
regulatory bodies. With respect to safety, we will not object to
statements that your drug
candidates were well-tolerated or that no serious adverse events were
reported. With
respect to statements that your clinical trials demonstrated efficacy,
you may present a
balanced summary of the data from the clinical trials but not your
conclusions that the
data demonstrates efficacy. Additionally, revise the descriptions of
your clinical trials to
describe the endpoints in terms of the objective data points you used
to draw your
conclusions.
Foralumab (TZLS-401 formerly known as NI-0401), page 51
4. Please revise your filing to disclose Professor Howard Weiner's and
Prof. Kevan Herold's
membership on your Scientific Advisory Board and any other material
relationships they
have with you.
Our Product Candidates, page 51
5. Please ensure that all graphs and charts are legible, including the
chart on page 65
summarizing your intellectual property portfolio. Additionally, please
provide us proofs
of all graphics, visual or photographic information you will provide
in the printed
prospectus prior to its use, for example in a preliminary prospectus.
Please note that we
may have comments regarding this material.
6. Please remove Crohn's disease from the pipeline development chart
since you have
determined not to pursue this indication. Additionally, it appears
from your disclosure
that you are not presently in the position to commence Phase 3
clinical development of
Micliclib for the treatment of thymic carcinoma/thymoma. Please revise
the arrow for
this indication so that it illustrates the current stage of
development.
Milciclib (TZLS-201) , page 56
7. Please expand your disclosure on page 57 to explain what you mean that
"a block in G1
Tiziano Lazzaretti
FirstName LastNameTiziano Lazzaretti
Tiziana Life Sciences plc
Comapany NameTiziana Life Sciences plc
January 19, 2018
June 16, 2017 Page 3
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FirstName LastName
phase of the cell cycle was observed" and the significance of
Milciclib being able to
"modulate the phosphorylation of the Retinoblastoma protein....as well
as to reduce
phosphorylation status of proteins of the TRKa signaling pathway in
cells expressing the
tyrosine kinase receptor." Explain how "significant" anti-tumor
activity and "consistent
tumor growth inhibition" were measured. Additionally, explain the
meaning of the
statement in the chart on page 60 that references "encouraging
clinical benefit in ~36%
patients" and tell us why you report the number of patients on page 61
as approximate.
Phase I Development, page 58
8. Please revise your table to describe the clinical trial observations
that you describe as
"disease stabilization," "partial response," and patient benefit.
Additionally, explain the
meaning of Cmax, daily AUC, CR and PR.
Phase II Data in Thymoma and Thymic Carcinoma , page 62
9. Please provide support for your estimated PFS survival rate at three
months of about 17%
and explain the meaning of "clinically interesting" in this context.
Anti-IL6R Fully Human mAb TZLS-501 (formerly known as NI-1201), page 63
10. Please explain how TZLS-501 demonstrated a decreased potential for
adverse events and
the potential for overcoming the limitations of other IL-6 pathway
drugs. Additionally,
describe the limitations of other IL-6 pathway drugs.
Intellectual Property , page 64
11. Please revise the table on page 65 to identify the licenses related to
your rights to each
patent family.
Collaborations and License Agreements, page 66
12. Please provide your analysis of the Nerviano Option to repurchase
shares. Include in this
analysis a description of the terms, your determination of accounting
treatment for the
option, and the specific accounting guidance on which you relied. In
addition,
specifically tell us why you paid Nerviano 2.1 million for the
subscription of 4.2 million
of your ordinary shares issued to Nerviano as indicated in the third
full paragraph on
page 67 and how this is consistent with your disclosure in Note 16 on
page F-18
regarding the issuance of these shares.
Item 5: Operating and Financial Review and Prospects
H. Critical Accounting Policies and Significant Judgments and Estimates
Income Taxes, page 90
Tiziano Lazzaretti
FirstName LastNameTiziano Lazzaretti
Tiziana Life Sciences plc
Comapany NameTiziana Life Sciences plc
January 19, 2018
June 16, 2017 Page 4
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FirstName LastName
13. Please tell us how your disclosed use of a valuation allowance against
deferred tax assets
and your two-step process to determine tax benefits to recognize for
uncertain income tax
positions complies with your stated policy in Note 2 on page F-8 and
the guidance in IAS
12.
Item 9: The Offer and Listing
A. Offering and Listing Details, page 102
14. You indicate that the reported closing prices of your ordinary shares
on the AIM is in
pounds Sterling; however, the amounts presented in the table appear to
be the amounts as
reported on the exchange in pence. Please revise your disclosure to
either move the
decimal point in your table to appropriately reflect your closing
prices in pounds Sterling
or indicate that the presented amounts are in pence. In addition,
please expand your
disclosure to include the annual high and low market prices of your
ordinary shares for
fiscal years ended December 31, 2015 and 2014, and update your
disclosure to provide
the closing prices for the most recent six months. Refer to Item 9.A.4
of Form 20-F.
Consolidated Statements of Operations and Comprehensive Loss, page F-4
15. Please address the following regarding your presentation of other
comprehensive loss and
comprehensive loss (referencing, where appropriate, the specific
accounting guidance on
which you relied):
Tell how your presentation complies with the guidance in paragraph
81A of IAS 1 to
present total other comprehensive income in a single statement of
profit or loss and
other comprehensive income or two separate statements. In this
regard, we note that:
o you present translation income/loss in your consolidated
statements of
shareholders' equity that is in addition to that presented in
this statement; and
o therefore, total comprehensive loss presented in this statement
differs from that
presented in your equity statement.
Tell us how your consolidated statements of cash flows complies with
the guidance in
paragraph 18 of IAS 7. In this regard, although you indicate that
those statements
begin with net loss, the amounts presented appear to include the
other comprehensive
loss that is reported in your consolidated statements of operations
and comprehensive
loss.
Notes to Consolidated Financial Statements
2. ACCOUNTING POLICIES
Basis of preparation, page F-7
16. Please revise your footnote disclosure to specifically indicate that
your financial
statements are prepared in accordance with IFRS as issued by the
International
Accounting Standards Board consistent with your disclosure on page 4
and in your
Tiziano Lazzaretti
Tiziana Life Sciences plc
January 19, 2018
Page 5
auditors' report. See Item 17(c) of Form 20-F.
Investments, page F-10
17. As your investments in subsidiary undertakings appear to be eliminated
in consolidation,
please tell us how your policy indicating that they are presented as
non-current assets
at cost less provision for any impairment is appropriate. Tell us the
specific accounting
guidance upon which you relied.
Share based payments, page F-11
18. Please tell us why it is appropriate to accelerate the vesting of share
options that are
cancelled. In this regard, tell us why vested share options on the
cancellation date were
not already recorded under paragraphs 15 and 20 of IFRS 2 and why
compensation
associated with unvested share options on the cancellation date is not
reversed under
paragraphs 19 and 20 of IFRS 2.
16. SHARE CAPITAL , page F-18
19. Please provide an analysis of the June 30, 2016 capital reduction
exercise, including a
description of the transaction, the amounts recorded as well as the
financial statement line
items impacted, and the accounting guidance on which you relied. In
addition, tell us
how you considered reporting the 41.3 million increase to retained
earnings in a
separate line item outside of retained earnings, given that this amount
does not represent
an accumulation of historical earnings.
You may contact Rolf Sundwall at (202) 551-3105 or Mark Brunhofer at
(202) 551-3638
if you have questions regarding comments on the financial statements and
related
matters. Please contact Christine Westbrook at (202) 551-5019 or Suzanne Hayes
at (202) 551-
3675 with any other questions.
FirstName LastNameTiziano Lazzaretti Division of
Corporation Finance
Comapany NameTiziana Life Sciences plc Office of
Healthcare & Insurance
June 16, 2017 Page 5
cc: Ed Lukins, Esq.
FirstName LastName