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Tiziana Life Sciences Ltd
Response Received
1 company response(s)
High - file number match
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Tiziana Life Sciences Ltd
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-02-01
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2021-02-01
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Company responded
2022-03-01
Tiziana Life Sciences Ltd
Summary
CORRESP · 2022-03-01
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Tiziana Life Sciences Ltd
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-01-28
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2020-01-28
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Company responded
2020-02-04
Tiziana Life Sciences Ltd
Summary
CORRESP · 2020-02-04
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Tiziana Life Sciences Ltd
Response Received
18 company response(s)
High - file number match
SEC wrote to company
2018-08-16
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2018-08-16
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Company responded
2018-08-31
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-08-31
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Company responded
2018-09-24
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-09-24
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Company responded
2018-10-18
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-10-18
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Company responded
2018-10-23
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-10-23
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Company responded
2018-10-30
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-10-30
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Company responded
2018-10-30
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-10-30
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Company responded
2018-11-02
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-02
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Company responded
2018-11-02
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-02
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Company responded
2018-11-05
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-05
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Company responded
2018-11-05
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-05
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Company responded
2018-11-07
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-07
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Company responded
2018-11-07
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-07
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Company responded
2018-11-07
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-07
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Company responded
2018-11-07
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-07
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Company responded
2018-11-09
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-09
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Company responded
2018-11-09
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-09
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Company responded
2018-11-19
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-19
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Company responded
2018-11-19
Tiziana Life Sciences Ltd
Summary
CORRESP · 2018-11-19
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Tiziana Life Sciences Ltd
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-10-23
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2018-10-23
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Tiziana Life Sciences Ltd
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-10-04
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2018-10-04
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Tiziana Life Sciences Ltd
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-09-24
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2018-09-24
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Tiziana Life Sciences Ltd
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-05-24
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2018-05-24
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Tiziana Life Sciences Ltd
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-03-13
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2018-03-13
Generating summary...
Tiziana Life Sciences Ltd
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-02-22
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2018-02-22
Generating summary...
Tiziana Life Sciences Ltd
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-01-22
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2018-01-22
Generating summary...
Tiziana Life Sciences Ltd
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-12-06
Tiziana Life Sciences Ltd
Summary
UPLOAD · 2017-12-06
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-27 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2025-03-27 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | 333-286064 | Read Filing View |
| 2022-03-01 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2021-02-01 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2020-02-04 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2020-01-28 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-19 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-19 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-09 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-09 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-07 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-07 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-07 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-07 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-05 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-05 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-02 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-02 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-30 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-30 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-23 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-23 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-18 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-04 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-09-24 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-09-24 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-08-31 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-08-16 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-05-24 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-03-13 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-02-22 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-01-22 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2017-12-06 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-27 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | 333-286064 | Read Filing View |
| 2021-02-01 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2020-01-28 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-23 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-04 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-09-24 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-08-16 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-05-24 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-03-13 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-02-22 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-01-22 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2017-12-06 | SEC Comment Letter | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-27 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2022-03-01 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2020-02-04 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-19 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-19 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-09 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-09 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-07 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-07 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-07 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-07 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-05 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-05 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-02 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-11-02 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-30 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-30 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-23 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-10-18 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-09-24 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
| 2018-08-31 | Company Response | Tiziana Life Sciences Ltd | Bermuda | N/A | Read Filing View |
2025-03-27 - CORRESP - Tiziana Life Sciences Ltd
CORRESP 1 filename1.htm Tiziana Life Sciences Ltd. Clarendon House, 2 Church Street, Hamilton HM 11, Bermuda March 27, 2025 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Tim Buchmiller Re: Tiziana Life Sciences Ltd. Form F-3 Registration Statement Filed March 24, 2025 File No. 333-286064 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Tiziana Life Sciences Ltd. (the "Company") respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5:00 p.m., Eastern Daylight Time, on Thursday, March 27, 2025, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. TIZIANA LIFE SCIENCES LTD. By: /s/ Keeren Shah Name: Keeren Shah Title: Chief Financial Officer
2025-03-27 - UPLOAD - Tiziana Life Sciences Ltd File: 333-286064
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 26, 2025 Ivor Elrifi Chief Executive Officer Tiziana Life Sciences Ltd 420 Lexington Avenue, Suite 2525 New York, NY 10170 Re: Tiziana Life Sciences Ltd Registration Statement on Form F-3 Filed March 24, 2025 File No. 333-286064 Dear Ivor Elrifi: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. 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. Please contact Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jeffrey J. Fessler, Esq. </TEXT> </DOCUMENT>
2022-03-01 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
Tiziana Life Sciences Ltd.
55 Park Lane
London
W1k 1NA
March 1, 2022
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Alan Campbell
Re:
Tiziana Life Sciences Ltd.
Amendment No. 1 to Form F-3 Registration Statement
Filed February 25, 2022
File No. 333-252441
Ladies and Gentlemen:
Pursuant to Rule 461 of the
General Rules and Regulations under the Securities Act of 1933, as amended, Tiziana Life Sciences Ltd. (the “Company”)
respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective
at 4:00 p.m., Eastern Standard Time, on Thursday, March 3, 2022, or as soon thereafter as possible.
Please notify Jeffrey Fessler
of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration
Statement has been declared effective pursuant to this acceleration request.
TIZIANA LIFE SCIENCES LTD.
By:
/s/ Kunwar Shailubhai
Name:
Kunwar Shailubhai
Title:
Chief Executive Officer
2021-02-01 - UPLOAD - Tiziana Life Sciences Ltd
United States securities and exchange commission logo
February 1, 2021
Kunwar Shailubhai
Chief Executive Officer
Tiziana Life Sciences plc
3rd Floor,
11-12 St James’s Square
London SW1Y 4LB
United Kingdom
Re:Tiziana Life Sciences plc
Registration Statement on Form F-3
Filed January 26, 2021
File No. 333-252441
Dear Mr. Shailubhai:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Deanna Virginio at 202-551-4530 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2020-02-04 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
Tiziana
Life Sciences plc
3rd Floor
11-12 St. James’s Square
London SW1Y 4LB
United Kingdom
February
4, 2020
VIA EDGAR
United States Securities
and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Jeffrey Gabor
Re:
Tiziana Life Sciences plc
Registration Statement on Form S-3, as amended
File No. 333-236013
Ladies and Gentlemen:
Pursuant to
Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Tiziana
Life Sciences Plc (the “Company”) respectfully requests that the effective date of the registration statement
referred to above be accelerated so that it will become effective at 9:00 a.m., Eastern Standard Time, on Thursday, February
6, 2020, or as soon thereafter as possible.
Please notify Jeffrey
Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to
the time the Registration Statement has been declared effective pursuant to this acceleration request.
Thank you,
TIZIANA LIFE SCIENCES PLC
By:
/s/ Kunwar Shailubhai
Name:
Kunwar Shailubhai
Title:
Chief Executive Officer
2020-01-28 - UPLOAD - Tiziana Life Sciences Ltd
January 27, 2020
Kunwar Shailubhai, Ph.D., M.B.A
Chief Executive Officer
Tiziana Life Sciences plc
20 Lexington Avenue, Suite 2525
New York, NY 10170
Re:Tiziana Life Sciences plc
Registration Statement on Form F-3
Filed January 22, 2020
File No. 333-236013
Dear Dr. Shailubhai:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Jeffrey Gabor at 202-551-2544 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey J. Fessler, Esq.
2018-11-19 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
LAIDLAW& COMPANY (UK) LTD.
521 Fifth Avenue, 12th Floor
New York, New York 10175
November 19, 2018
Via
EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Tiziana Life Sciences plc Post-Effective Amendment No. 1 to Registration Statement on Form F-1
(SEC File No. 333-226368)
Ladies and Gentleman:
In connection with
the above referenced Post-Effective Amendment No. 1 to Registration Statement on Form F-1, and pursuant to Rule 461 of the General
Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), the undersigned, the representative
of the several underwriters (the “Representative”), hereby joins in the request of Tiziana Life Sciences plc that the
effective date of the above-referenced Post-Effective Amendment No. 1 to Registration Statement on Form F-1 be accelerated so that
the Post-Effective Amendment No. 1 to Registration Statement on Form F-1 may become effective on 4:00 p.m. Eastern Standard Time
on Monday, November 19, 2018, or as soon as practicable thereafter.
Pursuant to Rule
460 under the Act, please be advised that during the period from September 25, 2018 through the date of this letter, the preliminary
prospectus, dated September 25, 2018 (the “Preliminary Prospectus”), in connection with the Registration Statement
of Form F-1, which was declared effective on Friday, November 9, 2018, were distributed (either in print or electronic form) approximately
as follows:
Copies to underwriters:
5
Copies to prospective dealers:
0
Copies to prospective institutional investors:
45
Copies to prospective retail investors:
100
Total
150
Copies of the Preliminary
Prospectus were available to anyone requesting the same at the offices of the underwriters.
The Representative
confirms on behalf of itself and the several underwriters that they have complied with and will continue to comply with Rule 15c2-8
promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Sincerely,
LAIDLAW & COMPANY (UK) LTD.
As Representative of the several underwriters
/s/ Hugh Regan
By:
Hugh Regan
Title:
Executive Director
2018-11-19 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
Tiziana
Life Sciences plc
3rd Floor, 11-12 St James’s Square
London SW1Y 4LB
United Kingdom
November
19, 2018
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Rolf
Sundwall
Mark
Brunhofer
Christine
Westbrook
Suzanne
Hayes
Re:
Tiziana
Life Sciences plc
Acceleration
Request for Post-Effective Amendment No. 1 to Registration Statement on Form F-1
File
No. 333-226368
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Tiziana Life Sciences plc (the “Company”)
hereby requests that the effective date of the above-referenced post-effective amendment No. 1 to the registration statement on
Form F-1 (the “Post-Effective Amendment No. 1 to Registration Statement on Form F-1”) be accelerated to Monday,
November 19, 2018, at 4:00 p.m., Eastern Standard Time, or as soon thereafter as practicable, unless we or our outside counsel,
Cooley (UK) LLP, request by telephone that such Post-Effective Amendment No. 1 to Registration Statement on Form F-1 be
declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities
under the Act.
Once
the Post-Effective Amendment No. 1 to Registration Statement on Form F-1 is effective, please orally confirm the event with our
counsel, Cooley (UK) LLP, by calling Edward Lukins at +44 (0) 20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230.
If
you have any questions regarding this request, please contact our counsel, Cooley (UK) LLP, by calling Edward Lukins at +44 (0)
20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230. Thank you for your assistance with this matter.
Sincerely,
TIZIANA
LIFE SCIENCES PLC
/s/
Kunwar Shailubhai
Kunwar
Shailubhai
Chief
Executive Officer
2018-11-09 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
LAIDLAW
& COMPANY (UK) LTD.
521 Fifth Avenue, 12th Floor
New York, New York 10175
November
9, 2018
Via
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Tiziana Life Sciences
plc Registration Statement on Form F-1
(SEC File No. 333-226368)
Ladies
and Gentleman:
In
connection with the above referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations under
the Securities Act of 1933, as amended (the “Act”), the undersigned, the representative of the several underwriters
(the “Representative”), hereby joins in the request of Tiziana Life Sciences plc that the effective date of the above-referenced
Registration Statement be accelerated so that the Registration Statement may become effective on 4:00 p.m. Eastern Standard Time
on Friday, November 9, 2018, or as soon as practicable thereafter.
Pursuant
to Rule 460 under the Act, please be advised that during the period from September 25, 2018 through the date of this letter, the
preliminary prospectus, dated September 25, 2018 (the “Preliminary Prospectus”), in connection with the Registration
Statement were distributed (either in print or electronic form) approximately as follows:
Copies to underwriters:
5
Copies to prospective dealers:
0
Copies to prospective institutional investors:
45
Copies to prospective retail investors:
100
Total
150
Copies
of the Preliminary Prospectus were available to anyone requesting the same at the offices of the underwriters.
The
Representative confirms on behalf of itself and the several underwriters that they have complied with and will continue to comply
with Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Sincerely,
LAIDLAW
& COMPANY (UK) LTD.
As Representative of the several
underwriters
/s/
Hugh Regan
By:
Hugh Regan
Title:
Executive Director
2018-11-09 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
Tiziana Life Sciences plc
3rd Floor, 11-12 St James’s Square
London SW1Y 4LB
United Kingdom
November 9, 2018
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Rolf Sundwall
Mark Brunhofer
Christine Westbrook
Suzanne Hayes
Re:
Tiziana Life Sciences plc
Acceleration Request for Registration Statement on Form F-1
File No. 333-226368
Ladies and Gentlemen:
Pursuant to Rule 461
under the Securities Act of 1933, as amended (the “Act”), Tiziana Life Sciences plc (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”)
be accelerated to Friday, November 9, 2018, at 4:00 p.m., Eastern Standard Time, or as soon thereafter as practicable, unless we
or our outside counsel, Cooley (UK) LLP, request by telephone that such Registration Statement be declared effective at some other
time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act.
Once the Registration
Statement is effective, please orally confirm the event with our counsel, Cooley (UK) LLP, by calling Edward Lukins at +44 (0)
20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230.
If you have any questions
regarding this request, please contact our counsel, Cooley (UK) LLP, by calling Edward Lukins at +44 (0) 20 7556 4261 or Edward
Dyson at +44(0) 20 7556 4230. Thank you for your assistance with this matter.
Sincerely,
TIZIANA LIFE SCIENCES PLC
/s/ Kunwar Shailubhai
Kunwar Shailubhai
Chief Executive Officer
2018-11-07 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
LAIDLAW & COMPANY (UK) LTD.
521 Fifth Avenue, 12th Floor
New York, New York 10175
November 7, 2018
Via
EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Tiziana Life Sciences plc Registration Statement on Form F-1
(SEC File No. 333-226368)
Ladies and Gentleman:
In connection with the
above referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations under the Securities Act
of 1933, as amended (the “Act”), the undersigned, the representative of the several underwriters (the “Representative”),
hereby joins in the request of Tiziana Life Sciences plc that the effective date of the above-referenced Registration Statement
be accelerated so that the Registration Statement may become effective on 4:00 p.m. Eastern Standard Time on Thursday, November
7, 2018, or as soon as practicable thereafter.
Pursuant to Rule 460
under the Act, please be advised that during the period from September 25, 2018 through the date of this letter, the preliminary
prospectus, dated September 25, 2018 (the “Preliminary Prospectus”), in connection with the Registration Statement
were distributed (either in print or electronic form) approximately as follows:
Copies to underwriters:
5
Copies to prospective dealers:
0
Copies to prospective institutional investors:
45
Copies to prospective retail investors:
100
Total
150
Copies of the Preliminary
Prospectus were available to anyone requesting the same at the offices of the underwriters.
The Representative confirms
on behalf of itself and the several underwriters that they have complied with and will continue to comply with Rule 15c2-8 promulgated
under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Sincerely,
LAIDLAW & COMPANY (UK) LTD.
As Representative of the several underwriters
/s/ Hugh Regan
By:
Hugh Regan
Title:
Executive Director
2018-11-07 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
Tiziana Life Sciences plc
3rd Floor, 11-12 St James’s Square
London SW1Y 4LB
United Kingdom
November 7, 2018
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Rolf Sundwall
Mark Brunhofer
Christine Westbrook
Suzanne Hayes
Re:
Tiziana Life Sciences plc
Acceleration Request for Registration Statement
on Form F-1
File
No. 333-226368
Ladies and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933, as amended (the “Act”), Tiziana Life Sciences plc (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”)
be accelerated to Thursday, November 8, 2018, at 4:00 p.m., Eastern Standard Time, or as soon thereafter as practicable, unless
we or our outside counsel, Cooley (UK) LLP, request by telephone that such Registration Statement be declared effective at some
other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act.
Once the Registration
Statement is effective, please orally confirm the event with our counsel, Cooley (UK) LLP, by calling Edward Lukins at +44 (0)
20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230.
If you have any
questions regarding this request, please contact our counsel, Cooley (UK) LLP, by calling Edward Lukins at +44 (0) 20 7556 4261
or Edward Dyson at +44(0) 20 7556 4230. Thank you for your assistance with this matter.
Sincerely,
TIZIANA LIFE SCIENCES PLC
/s/ Kunwar Shailubhai
Kunwar Shailubhai
Chief Executive Officer
2018-11-07 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
LAIDLAW & COMPANY (UK) LTD.
521 Fifth Avenue, 12th Floor
New York, New York 10175
November 7, 2018
Via
EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Tiziana Life Sciences plc Registration Statement on Form F-1
(SEC File No. 333-226368)
Ladies and Gentleman:
In connection with
the above referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations under the Securities
Act of 1933, as amended (the “Act”), the undersigned, the representative of the several underwriters (the “Representative”),
hereby joins in the request of Tiziana Life Sciences plc that the effective date of the above-referenced Registration Statement
be accelerated so that the Registration Statement may become effective on 4:00 p.m. Eastern Standard Time on Thursday, November
8, 2018, or as soon as practicable thereafter.
Pursuant to Rule
460 under the Act, please be advised that during the period from September 25, 2018 through the date of this letter, the preliminary
prospectus, dated September 25, 2018 (the “Preliminary Prospectus”), in connection with the Registration Statement
were distributed (either in print or electronic form) approximately as follows:
Copies to underwriters:
5
Copies to prospective dealers:
0
Copies to prospective institutional investors:
45
Copies to prospective retail investors:
100
Total
150
Copies of the
Preliminary Prospectus were available to anyone requesting the same at the offices of the underwriters.
The Representative
confirms on behalf of itself and the several underwriters that they have complied with and will continue to comply with Rule 15c2-8
promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Sincerely,
LAIDLAW & COMPANY (UK) LTD.
As Representative of the several underwriters
/s/ Hugh Regan
By:
Hugh Regan
Title:
Executive Director
2018-11-07 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
Tiziana
Life Sciences plc
3rd Floor, 11-12 St James’s Square
London SW1Y 4LB
United Kingdom
November
7, 2018
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Rolf
Sundwall
Mark
Brunhofer
Christine
Westbrook
Suzanne
Hayes
Re:
Tiziana
Life Sciences plc
Acceleration
Request for Registration Statement on Form F-1
File
No. 333-226368
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Tiziana Life Sciences plc (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”)
be accelerated to Thursday, November 7, 2018, at 4:00 p.m., Eastern Standard Time, or as soon thereafter as practicable, unless
we or our outside counsel, Cooley (UK) LLP, request by telephone that such Registration Statement be declared effective at some
other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act.
Once
the Registration Statement is effective, please orally confirm the event with our counsel, Cooley (UK) LLP, by calling Edward
Lukins at +44 (0) 20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230.
If
you have any questions regarding this request, please contact our counsel, Cooley (UK) LLP, by calling Edward Lukins at +44 (0)
20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230. Thank you for your assistance with this matter.
Sincerely,
TIZIANA
LIFE SCIENCES PLC
/s/
Kunwar Shailubhai
Kunwar
Shailubhai
Chief
Executive Officer
2018-11-05 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
LAIDLAW & COMPANY (UK) LTD.
521 Fifth Avenue, 12th Floor
New York, New York 10175
November 5, 2018
Via
EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Tiziana Life Sciences plc Registration Statement on Form F-1
(SEC File No. 333-226368)
Ladies and Gentleman:
In connection with the
above referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations under the Securities Act
of 1933, as amended (the “Act”), the undersigned, the representative of the several underwriters (the “Representative”),
hereby joins in the request of Tiziana Life Sciences plc that the effective date of the above-referenced Registration Statement
be accelerated so that the Registration Statement may become effective on 4:00 p.m. Eastern Standard Time on Tuesday, November 6, 2018, or as soon as practicable thereafter.
Pursuant to Rule
460 under the Act, please be advised that during the period from September 25, 2018 through the date of this letter, the preliminary
prospectus, dated September 25, 2018 (the “Preliminary Prospectus”), in connection with the Registration Statement
were distributed (either in print or electronic form) approximately as follows:
Copies to underwriters:
5
Copies to prospective dealers:
0
Copies to prospective institutional investors:
45
Copies to prospective retail investors:
100
Total
150
Copies of the Preliminary
Prospectus were available to anyone requesting the same at the offices of the underwriters.
The Representative confirms
on behalf of itself and the several underwriters that they have complied with and will continue to comply with Rule 15c2-8 promulgated
under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Sincerely,
LAIDLAW & COMPANY (UK) LTD.
As Representative of the several underwriters
/s/ Hugh Regan
By:
Hugh Regan
Title:
Executive Director
2018-11-05 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
Tiziana Life Sciences plc
3rd Floor, 11-12 St James’s Square
London SW1Y 4LB
United Kingdom
November
5, 2018
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention: Rolf
Sundwall
Mark
Brunhofer
Christine Westbrook
Suzanne
Hayes
Re: Tiziana
Life Sciences plc
Acceleration
Request for Registration Statement on Form F-1
File No. 333-226368
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Tiziana Life Sciences plc (the
“Company”) hereby requests that the effective date of the above-referenced registration statement (the
“Registration Statement”) be accelerated to Tuesday, November 6, 2018, at 4:00 p.m., Eastern Standard
Time, or as soon thereafter as practicable, unless we or our outside counsel, Cooley (UK) LLP, request by telephone that such
Registration Statement be declared effective at some other time. In making this acceleration request, the Company
acknowledges that it is aware of its responsibilities under the Act.
Once
the Registration Statement is effective, please orally confirm the event with our counsel, Cooley (UK) LLP, by calling Edward
Lukins at +44 (0) 20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230.
If
you have any questions regarding this request, please contact our counsel, Cooley (UK) LLP, by calling Edward Lukins at +44 (0)
20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230. Thank you for your assistance with this matter.
Sincerely,
TIZIANA
LIFE SCIENCES PLC
/s/ Kunwar
Shailubhai
Kunwar
Shailubhai
Chief
Executive Officer
2018-11-02 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
Tiziana Life Sciences plc
3rd Floor, 11-12 St James’s Square
London SW1Y 4LB
United Kingdom
November
2, 2018
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention: Rolf
Sundwall
Mark
Brunhofer
Christine Westbrook
Suzanne
Hayes
Re: Tiziana
Life Sciences plc
Acceleration
Request for Registration Statement on Form F-1
File No. 333-226368
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Tiziana Life Sciences plc (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”)
be accelerated to Monday, November 5, 2018, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our
outside counsel, Cooley (UK) LLP, request by telephone that such Registration Statement be declared effective at some other time.
In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act.
Once
the Registration Statement is effective, please orally confirm the event with our counsel, Cooley (UK) LLP, by calling Edward
Lukins at +44 (0) 20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230.
If
you have any questions regarding this request, please contact our counsel, Cooley (UK) LLP, by calling Edward Lukins at +44 (0)
20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230. Thank you for your assistance with this matter.
Sincerely,
TIZIANA
LIFE SCIENCES PLC
/s/ Kunwar
Shailubhai
Kunwar
Shailubhai
Chief
Executive Officer
2018-11-02 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
LAIDLAW & COMPANY (UK) LTD.
521 Fifth Avenue, 12th Floor
New York, New York 10175
November 2, 2018
Via
EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Tiziana Life Sciences plc Registration Statement on Form F-1
(SEC File No. 333-226368)
Ladies and Gentleman:
In connection with the
above referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations under the Securities Act
of 1933, as amended (the “Act”), the undersigned, the representative of the several underwriters (the “Representative”),
hereby joins in the request of Tiziana Life Sciences plc that the effective date of the above-referenced Registration Statement
be accelerated so that the Registration Statement may become effective on 4:00 p.m. Eastern Time on Monday, November 5, 2018, or
as soon as practicable thereafter.
Pursuant to Rule
460 under the Act, please be advised that during the period from September 25, 2018 through the date of this letter, the preliminary
prospectus, dated September 25, 2018 (the “Preliminary Prospectus”), in connection with the Registration Statement
were distributed (either in print or electronic form) approximately as follows:
Copies to underwriters:
5
Copies to prospective dealers:
0
Copies to prospective institutional investors:
45
Copies to prospective retail investors:
100
Total
150
Copies of the Preliminary
Prospectus were available to anyone requesting the same at the offices of the underwriters.
The Representative confirms
on behalf of itself and the several underwriters that they have complied with and will continue to comply with Rule 15c2-8 promulgated
under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Sincerely,
LAIDLAW & COMPANY (UK) LTD.
As Representative of the several underwriters
/s/ Hugh Regan
By:
Hugh Regan
Title:
Executive Director
2018-10-30 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
Tiziana
Life Sciences plc
3rd
Floor, 11-12 St James’s Square
London
SW1Y 4LB
United Kingdom
VIA
EDGAR
October
30, 2018
United
States Securities and Exchange Commission
Division of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Rolf Sundwall
Mark Brunhofer
Christine Westbrook
Suzanne Hayes
Re:
Tiziana
Life Sciences plc
Acceleration Request for Registration Statement on Form F-1
File No. 333-226368
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Tiziana Life Sciences plc (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”)
be accelerated to Thursday, November 1, 2018, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our
outside counsel, Cooley (UK) LLP, request by telephone that such Registration Statement be declared effective at some other time.
In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act.
Once
the Registration Statement is effective, please orally confirm the event with our counsel, Cooley (UK) LLP, by calling Edward
Lukins at +44 (0) 20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230.
If
you have any questions regarding this request, please contact our counsel, Cooley (UK) LLP, by calling Edward Lukins at +44 (0)
20 7556 4261 or Edward Dyson at +44(0) 20 7556 4230. Thank you for your assistance with this matter.
Sincerely,
TIZIANA LIFE SCIENCES
PLC
/s/
Kunwar Shailubhai
Kunwar
Shailubhai
Chief
Executive Officer
2018-10-30 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
LAIDLAW
& COMPANY (UK) LTD.
521 Fifth Avenue, 12th Floor
New York, New York 10175
October
30, 2018
Via
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re: Tiziana
Life Sciences plc Registration Statement on Form F-1
(SEC File No. 333-226368)
Ladies
and Gentleman:
In
connection with the above referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations under
the Securities Act of 1933, as amended (the “Act”), the undersigned, the representative of the several underwriters
(the “Representative”), hereby joins in the request of Tiziana Life Sciences plc that the effective date of the above-referenced
Registration Statement be accelerated so that the Registration Statement may become effective on 4:00 p.m. Eastern Time on Thursday,
November 1, 2018, or as soon as practicable thereafter.
Pursuant
to Rule 460 under the Act, please be advised that during the period from September 25, 2018 through the date of this letter, the
preliminary prospectus, dated September 25, 2018 (the “Preliminary Prospectus”), in connection with the Registration
Statement were distributed (either in print or electronic form) approximately as follows:
Copies to underwriters:
5
Copies to prospective dealers:
0
Copies to prospective institutional investors:
45
Copies to prospective retail investors:
100
Total
150
Copies
of the Preliminary Prospectus were available to anyone requesting the same at the offices of the underwriters.
The
Representative confirms on behalf of itself and the several underwriters that they have complied with and will continue to comply
with Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Sincerely,
LAIDLAW & COMPANY (UK) LTD.
As Representative of the several underwriters
/s/ Hugh Regan
By:
Hugh
Regan
Title:
Executive
Director
2018-10-23 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
October
23, 2018
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attn: Rolf
Sundwall
Mark
Brunhofer
Christine
Westbrook
Suzanne
Hayes
Re: Tiziana
Life Sciences plc
Amendment
No. 3 to Registration Statement on Form F-1
Filed
October 18, 2018
File
No. 333-226368
Ladies
and Gentlemen:
On
behalf of Tiziana Life Sciences plc (the “Company”), we are submitting this letter and the following
information in response to a letter, dated October 3, 2018, from the staff (the “Staff”) of the U.S.
Securities and Exchange Commission (the “Commission”) with respect to the Company’s registration
statement on Form F-1 (Amendment 3) submitted on October 18, 2018 (the “Registration Statement”). We
are also electronically transmitting an amended version of the Registration Statement (“Amendment 4”)
and sending the Staff a hard copy of this letter, Amendment 4 and a blackline between Amendment 4 and Amendment 3.
The
numbering of the paragraphs below corresponds to the numbering of the comments in the letter. For the Staff’s convenience,
we have incorporated your comments into this response letter in italics. Capitalized terms used in this letter but otherwise not
defined herein shall have the meanings ascribed to such terms in Amendment 4.
Registration
Statement on Form F-1
Prospectus Summary
Selected
Risks Affecting Our Business, page 4
1. We
note your response to comment 1, which we reissue. Please also amend your disclosure in the Summary section to highlight the risk
that certain existing shareholders will exert significant influence over matters that require shareholder approval.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has amended the relevant
disclosure accordingly on page 5.
Cooley
(UK) LLP Dashwood 69 Old Broad Street London EC2M 1QS, UK
t: +44 (0) 20 7583 4055 f: +44 (0) 20 7785 9355 cooley.com
Cooley
(UK) LLP is a limited liability partnership and is registered in England and Wales with registered number OC395270. Our registered
office is at the address above. Cooley (UK) LLP is authorised and regulated by the Solicitors Regulation Authority (SRA number
617791). A list of the members of Cooley (UK) LLP and their professional qualifications is open to inspection at its registered
office. The word ‘partner,’ used in relation to Cooley (UK) LLP, refers to a member of Cooley (UK) LLP or an employee or consultant
of Cooley (UK) LLP (or any affiliated firm) of equivalent standing.
U.S.
Securities and Exchange Commission
October 23, 2018
Page
2
Capitalization,
page 51
2. Please
revise your presentation so that the balance of your cash and short-term deposits and short-term investments is not included in
the total capitalization amount.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has revised the presentation
accordingly on page 51.
3. Refer
to our prior comment 3. Please explain to us how the increase in cash and short term deposits and short-term investments between
the Actual and Pro Forma columns of your disclosure reflects the $1,163,550 of gross proceeds from the issuance of unsecured loans.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has reflected the use
of the $1,163,550 gross proceeds in the pro forma column on page 51. The majority of the gross proceeds were used to clear existing
liabilities and the cash position on the pro forma reflects the Company’s cash balance at the pro forma date.
Cooley
(UK) LLP Dashwood 69 Old Broad Street London EC2M 1QS, UK
t: +44 (0) 20 7583 4055 f: +44 (0) 20 7785 9355 cooley.com
Cooley
(UK) LLP is a limited liability partnership and is registered in England and Wales with registered number OC395270. Our registered
office is at the address above. Cooley (UK) LLP is authorised and regulated by the Solicitors Regulation Authority (SRA number
617791). A list of the members of Cooley (UK) LLP and their professional qualifications is open to inspection at its registered
office. The word ‘partner,’ used in relation to Cooley (UK) LLP, refers to a member of Cooley (UK) LLP or an employee or consultant
of Cooley (UK) LLP (or any affiliated firm) of equivalent standing.
U.S.
Securities and Exchange Commission
October 23, 2018
Page
3
Please
contact me at +44 (0) 20 7556 4230 with any questions or further comments regarding the Company’s responses to the Staff’s
comments.
Yours
sincerely,
/s/
Edward Dyson
Edward
Dyson
cc: Tiziano
Lazzaretti, Tiziana Life Sciences plc
Cooley
(UK) LLP Dashwood 69 Old Broad Street London EC2M 1QS, UK
t: +44 (0) 20 7583 4055 f: +44 (0) 20 7785 9355 cooley.com
Cooley
(UK) LLP is a limited liability partnership and is registered in England and Wales with registered number OC395270. Our registered
office is at the address above. Cooley (UK) LLP is authorised and regulated by the Solicitors Regulation Authority (SRA number
617791). A list of the members of Cooley (UK) LLP and their professional qualifications is open to inspection at its registered
office. The word ‘partner,’ used in relation to Cooley (UK) LLP, refers to a member of Cooley (UK) LLP or an employee or consultant
of Cooley (UK) LLP (or any affiliated firm) of equivalent standing.
2018-10-23 - UPLOAD - Tiziana Life Sciences Ltd
October 22, 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
Amendment No. 3 to Registration Statement on Form F-1
Filed October 18, 2018
File No. 333-226368
Dear Mr. Lazzaretti:
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 October 3, 2018 letter.
Amendment No. 3 to Registration Statement on Form F-1 filed October 18, 2018
Prospectus Summary
Selected Risks Affecting Our Business, page 4
1.We note your response to comment 1, which we reissue. Please also amend your
disclosure in the Summary section to highlight the risk that certain existing shareholders
will exert significant influence over matters that require shareholder approval.
FirstName LastNameTiziano Lazzaretti
Comapany NameTiziana Life Sciences plc
October 22, 2018 Page 2
FirstName LastName
Tiziano Lazzaretti
Tiziana Life Sciences plc
October 22, 2018
Page 2
Capitalization, page 51
2.Please revise your presentation so that the balance of your cash and short-term deposits
and short-term investments is not included in the total capitalization amount.
3.Refer to our prior comment 3. Please explain to us how the increase in cash and short-
term deposits and short-term investments between the Actual and Pro Forma columns of
your disclosure reflects the $1,163,550 of gross proceeds from the issuance of unsecured
loans.
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.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ed Lukins, Esq.
2018-10-18 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
October 17, 2018
U.S. Securities and Exchange
Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Rolf Sundwall
Mark Brunhofer
Christine Westbrook
Suzanne Hayes
Re: Tiziana Life Sciences plc
Amendment No.3 to Registration Statement
on Form F-1
Filed October 8, 2018
File No. 333-226368
Ladies and Gentlemen:
On behalf
of Tiziana Life Sciences plc (the “Company”), we are submitting this letter and the following information
in response to a letter, dated October 3, 2018, from the staff (the “Staff”) of the U.S. Securities and
Exchange Commission (the “Commission”) with respect to the Company’s registration statement on
Form F-1 (Amendment 2) submitted on September 25, 2018 (the “Registration Statement”). We are also electronically
transmitting an amended version of the Registration Statement (“Amendment 3”) and sending the Staff a
hard copy of this letter, Amendment 3 and a blackline between Amendment 3 and Amendment 2.
The numbering
of the paragraphs below corresponds to the numbering of the comments in the letter. For the Staff’s convenience, we have
incorporated your comments into this response letter in italics. Capitalized terms used in this letter but otherwise not defined
herein shall have the meanings ascribed to such terms in Amendment 3.
Registration Statement on Form F-1
Prospectus
Summary
Selected Risks Affecting Our Business, page 4
1. We note your comment to expand your disclosure to highlight that risk that concentration of
ownership of your ordinary shares will result in directors, officers and 10% shareholders exerting significant influence over matters
that require shareholder vote, as discussed on page 41.
Response: The Company
respectfully acknowledges the Staff’s comment and advises the Staff that the Company has expanded disclosure to set out in
greater details the implications for investors at the same time noting the constraints on Mr Cerrone in further consolidating control.
Cooley (UK) LLP Dashwood 69 Old Broad Street
London EC2M 1QS, UK
t: +44 (0) 20 7583 4055 f: +44 (0) 20 7785 9355 cooley.com
Cooley (UK) LLP is a limited liability partnership
and is registered in England and Wales with registered number OC395270. Our registered office is at the address above. Cooley (UK)
LLP is authorised and regulated by the Solicitors Regulation Authority (SRA number 617791). A list of the members of Cooley (UK)
LLP and their professional qualifications is open to inspection at its registered office. The word ‘partner,’ used in relation
to Cooley (UK) LLP, refers to a member of Cooley (UK) LLP or an employee or consultant of Cooley (UK) LLP (or any affiliated firm)
of equivalent standing.
U.S. Securities and Exchange Commission
October 17, 2018
Page 2
Capitalization, page 51
2. We note your comment requesting revision of the presentation to include the balance of interest
bearing loans and borrowings in the total capitalization amounts.
Response: The Company
respectfully acknowledges the Staff’s comment and advises the Staff that the Company has revised the presentation accordingly.
3. We note your comment with respect to disclosure surrounding the pro forma presentation gives
effect to loans with gross proceeds of $1,163,550 and the request explain to us the change in cash and short-term deposits and
short- term investments between the Actual and Pro Forma columns of your disclosure. We also note the request for clarification,
in the Dilution section on page 52 and in the offering summary beginning on page 7 that the loans are convertible, as per the disclosures
on page F-24, and whether the conversions are excluded from your pro forma as adjusted disclosures. We also note the request to
advice whether the loans become convertible at the option of the holder or of the company following the requisite fundraising event.
Response: The Company
respectfully acknowledges the Staff’s comment and advises the Staff that the Company has approached the providers of the
loans and agreed that they will all convert at the offering price (with the lenders receiving AIM traded ordinary shares, not ADSs).
This is now reflected in the Pro Forma disclosure and relevant notes and in the Dilution and Summary sections.
Exhibits
4. We note the request to amend the disclaimer in Section 23 of the Deposit Agreement so that it
reflects amended Section 14(q) of the form of American Depositary Receipt.
Response: The Company
respectfully acknowledges the Staff’s comment and advises the Staff that the Company has been advised by Depositary Counsel
that no amendment is required to Section 23 of the Depositary Agreement, as that section merely waives jury trial when a trial
is being held, and that, in any event the entire form of American Depositary Receipt is incorporated by reference into the front
portion of the Deposit Agreement.
Cooley (UK) LLP Dashwood 69 Old Broad Street
London EC2M 1QS, UK
t: +44 (0) 20 7583 4055 f: +44 (0) 20 7785 9355 cooley.com
Cooley (UK) LLP is a limited liability partnership
and is registered in England and Wales with registered number OC395270. Our registered office is at the address above. Cooley (UK)
LLP is authorised and regulated by the Solicitors Regulation Authority (SRA number 617791). A list of the members of Cooley (UK)
LLP and their professional qualifications is open to inspection at its registered office. The word ‘partner,’ used in relation
to Cooley (UK) LLP, refers to a member of Cooley (UK) LLP or an employee or consultant of Cooley (UK) LLP (or any affiliated firm)
of equivalent standing.
U.S. Securities and Exchange Commission
October 17, 2018
Page 3
Please contact me at +44 (0) 20 7556 4230
with any questions or further comments regarding the Company’s responses to the Staff’s comments.
Yours sincerely,
/s/ Edward Dyson
Edward Dyson
cc: Tiziano Lazzaretti, Tiziana Life Sciences plc
Cooley (UK) LLP Dashwood 69 Old Broad Street
London EC2M 1QS, UK
t: +44 (0) 20 7583 4055 f: +44 (0) 20 7785 9355 cooley.com
Cooley (UK) LLP is a limited liability partnership
and is registered in England and Wales with registered number OC395270. Our registered office is at the address above. Cooley (UK)
LLP is authorised and regulated by the Solicitors Regulation Authority (SRA number 617791). A list of the members of Cooley (UK)
LLP and their professional qualifications is open to inspection at its registered office. The word ‘partner,’ used in relation
to Cooley (UK) LLP, refers to a member of Cooley (UK) LLP or an employee or consultant of Cooley (UK) LLP (or any affiliated firm)
of equivalent standing.
2018-10-04 - UPLOAD - Tiziana Life Sciences Ltd
October 3, 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
Amendment No. 2 to Registration Statement on Form F-1
Filed September 25, 2018
File No. 333-226368
Dear Mr. Lazzaretti:
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 August 31, 2018 letter.
Registration Statement on Form F-1
Prospectus Summary
Selected Risks Affecting Our Business, page 4
1.Please expand your disclosure to highlight that risk that concentration of ownership of
your ordinary shares will result in directors, officers and 10% shareholders exerting
significant influence over matters that require shareholder vote, as discussed on page 41.
FirstName LastNameTiziano Lazzaretti
Comapany NameTiziana Life Sciences plc
October 3, 2018 Page 2
FirstName LastName
Tiziano Lazzaretti
Tiziana Life Sciences plc
October 3, 2018
Page 2
Capitalization, page 51
2.Please revise your presentation to include the balance of interest bearing loans and
borrowings in the total capitalization amounts.
3.You disclose that the pro forma presentation gives effect to loans with gross proceeds of
$1,163,550. Please explain to us the change in cash and short-term deposits and short-
term investments between the Actual and Pro Forma columns of your disclosure. Also,
please clarify here, in the Dilution section on page 52 and in the offering summary
beginning on page 7 that the loans are convertible, as per your disclosures on page F-24,
and whether the conversions are excluded from your pro forma as adjusted disclosures.
Tell us whether the loans become convertible at the option of the holder or of the
company following the requisite fundraising event.
Exhibits
4.We acknowledge your response to comment 1. Please also amend the disclaimer in
Section 23 of the Deposit Agreement so that it reflects amended Section 14(q) of the form
of American Depositary Receipt.
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.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ed Lukins, Esq.
2018-09-24 - CORRESP - Tiziana Life Sciences Ltd
CORRESP
1
filename1.htm
Ed Lukins
+44
(0) 20 7556 4261
elukins@cooley.com
September 24, 2018
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Rolf Sundwall
Mark
Brunhofer
Christine
Westbrook
Suzanne
Hayes
Re:
Tiziana Life Sciences plc
Registration
Statement on Form F-1/A No. 1
Filed
August 23, 2018
File
No. 333-226368
Ladies
and Gentlemen:
On
behalf of Tiziana Life Sciences plc (the “Company”), we are submitting this letter and the following
information in response to a letter, dated August 31, 2018, from the staff (the “Staff”) of the U.S.
Securities and Exchange Commission (the “Commission”) with respect to the Company’s registration
statement on Form F-1 (Amendment 1) submitted on August 23, 2018 (the “Registration Statement”). We
are also electronically transmitting an amended version of the Registration Statement (“Amendment 2”)
and sending the Staff a hard copy of this letter, Amendment 2 and a blackline between Amendment 2 and Amendment 1. The Staff should
also be aware that Amendment 2 contains information extracted Company’s unaudited interim financial information for the
six month period ended June 30, 2018, which was released via regulatory information service in the United Kingdom on the date
of this letter.
The
numbering of the paragraphs below corresponds to the numbering of the comments in the letter. For the Staff’s convenience,
we have incorporated your comments into this response letter in italics. Capitalized terms used in this letter but otherwise not
defined herein shall have the meanings ascribed to such terms in Amendment 2.
Exhibits
1. We
note that the form of American Depositary Receipt included in the form of Deposit Agreement
filed as Exhibit 4.1 provides in relevant part that “No disclaimer of liability
under the Securities Act of 1933 is intended by any provision hereof.” Please amend
this section 14(q) so that it specifically provides that no disclaimer of liability under
the US federal securities laws or the rules and regulations thereunder is intended by
any provision thereof. Please make the corresponding revision to the form of Deposit
Agreement.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has amended the relevant
text on page 131 of Amendment 2, and in section 14(q) of the revised Exhibit 4.1.
***
[Signature
Page Follows]
U.S.
Securities and Exchange Commission
September 24, 2018
Page
2
Please
contact me at +44 (0) 20 7556 4261 with any questions or further comments regarding the Company’s responses to the Staff’s
comments.
Yours
sincerely,
/s/ Ed Lukins
Ed Lukins
cc:
Tiziano Lazzaretti, Tiziana Life Sciences plc
Cooley
(UK) LLP Dashwood 69 Old Broad Street London EC2M 1QS, UK
t: +44 (0) 20 7583 4055 f: +44 (0) 20 7785 9355 cooley.com
Cooley
(UK) LLP is a limited liability partnership and is registered in England and Wales with registered number OC395270. Our registered
office is at the address above. Cooley (UK) LLP is authorised and regulated by the Solicitors Regulation Authority (SRA number
617791). A list of the members of Cooley (UK) LLP and their professional qualifications is open to inspection at its registered
office. The word ‘partner,’ used in relation to Cooley (UK) LLP, refers to a member of Cooley (UK) LLP or an employee
or consultant of Cooley (UK) LLP (or any affiliated firm) of equivalent standing.
2018-09-24 - UPLOAD - Tiziana Life Sciences Ltd
August 31, 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
Amendment No. 1 to Registration Statement on Form F-1
Filed August 23, 2018
File No. 333-226368
Dear Mr. Lazzaretti:
We have reviewed your amended registration statement and have the following
comment. In our comment, 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 comment applies 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 the comment, we may have additional comments.
Amendment No. 1 to Registration Statement on Form F-1 filed August 23, 2018
Exhibits
1.We note that the form of American Depositary Receipt included in the form of Deposit
Agreement filed as Exhibit 4.1 provides in relevant part that "No disclaimer of liability
under the Securities Act of 1933 is intended by any provision hereof." Please amend this
section 14(q) so that it specifically provides that no disclaimer of liability under the US
federal securities laws or the rules and regulations thereunder is intended by any provision
thereof. Please make the corresponding revision to the form of Deposit Agreement.
FirstName LastNameTiziano Lazzaretti
Comapany NameTiziana Life Sciences plc
August 31, 2018 Page 2
FirstName LastName
Tiziano Lazzaretti
Tiziana Life Sciences plc
August 31, 2018
Page 2
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.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ed Lukins, Esq.
2018-08-31 - CORRESP - Tiziana Life Sciences Ltd
CORRESP 1 filename1.htm Ed Lukins +44 (0) 20 7556 4261 elukins@cooley.com August 23, 2018 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Rolf Sundwall Mark Brunhofer Christine Westbrook Suzanne Hayes Re: Tiziana Life Sciences plc Registration Statement on Form F-1 Filed July 26, 2018 File No. 333-226368 Ladies and Gentlemen: On behalf of Tiziana Life Sciences plc (the “Company”), we are submitting this letter and the following information in response to a letter, dated August 16, 2018, from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s registration statement on Form F-1 submitted on July 26, 2018 (the “Registration Statement”). We are also electronically transmitting an amended version of the Registration Statement (“Amendment 1”) and sending the Staff a hard copy of this letter, Amendment 1 and a blackline between Amendment 1 and the Registration Statement. The numbering of the paragraphs below corresponds to the numbering of the comments in the letter. For the Staff’s convenience, we have incorporated your comments into this response letter in italics. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings ascribed to such terms in Amendment 1. Cover page 1. We note your statement that no assurance can be given that your application to list your American Depositary Shares on the Nasdaq Capital Market will be approved. If your offering is not contingent on listing approval, please revise your cover page disclosure to clarify this fact. Additionally, please include a risk factor describing the consequences of not securing Nasdaq listing approval. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has removed the relevant statement on the cover page. U.S. Securities and Exchange Commission August 23, 2018 Page 2 2. We note your disclosure that the last reported sale price of your ordinary shares on AIM was £ ___ per ordinary share, equivalent to $ ___ per ADS. You may use the most recent home market trading price, converted to U.S. dollars at the most recent exchange rate, assuming the U.S. IPO price will be substantially similar to the home market trading price. If you expect that the U.S. IPO price will not be substantially similar to the home market trading price, please disclose on the prospectus cover page a bona fide price range of the offered securities. If you intend to price the securities based on the AIM market price, you may disclose a percentage range based on that price (for example, 10% of the home market price) within which you intend to price the securities. See Item 501(b)(3) of Regulation S-K. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company will opt to disclose the most recent home market trading price, converted to U.S. dollars at the most recent exchange rate, on the basis that the U.S. IPO price will be substantially similar to the home market trading price. Prospectus Summary Our Strategy, page 3 3. We note your statement that your goal is to deliver best-in-class and potentially life-altering therapies. Given the development stage of your product candidates and length of the drug approval process, it is premature and inappropriate for you to imply that any of your product candidates will ultimately be approved or become best-in-class or life-altering. Please remove this statement here and on page 65. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has removed the relevant statement on pages 3 and 65. Our Product Candidates Clinical Development Pipeline, page 4 4. We note your disclosure on page 1 that you plan to initially investigate Foralumab for safety and its immunomodulatory activity in healthy volunteers in two Phase 1 trials. Please revise your pipeline development chart to remove the studies conducted by Novimmune for the intravenous formulation and ensure that it accurately reflects the development status for your stated strategy. Additionally, with respect to references to the studies conducted by Novimmune, please revise your disclosure to remove your conclusions, i.e., “encouraging clinical response,” to reference objective data points from which your conclusions were drawn. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has included an updated product candidate pipeline chart on pages 4 and 66, and revised the relevant disclosure on page 70. U.S. Securities and Exchange Commission August 23, 2018 Page 3 Implications of Being an Emerging Growth Company, page 5 5. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that no materials have been furnished to any potential investors nor will any contact be made with potential investors or such materials delivered until the registrations statement is free of unresolved comments with the Staff. Use of Proceeds, page 48 6. Please revise the Use of Proceeds discussion to quantify the amounts you expect to allocate to Miliciclib and Foralumab separately. It appears from your disclosure that the proceeds from the offering will not be sufficient to fund development of your product candidates through regulatory approval and commercialization. Please indicate how far the proceeds from the offering will allow you to proceed with the continued development of Milciclib and Foralumab. Also disclose the sources of other funds needed to reach regulatory approval and commercialization for each product candidate. Refer to Item 3.C of Form 20-F required by Item 4 of Form F-1. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company had revised the relevant use of proceeds disclosure on pages 7 and 48. The Company is not in a position to populate the U.S. dollar amounts in the Use of Proceeds section, given it has not yet undertaken roadshow meetings. The Company also respectfully advises the Staff that given the inherent uncertainty regarding the timing of results and outcome of research and development into each of its product candidates, it is unable to make a definitive statement as to the sources of other funds needed to reach regulatory approval and commercialization for each such product candidate, and would refer the Staff to the risk factor on page 14 entitled: “We need substantial additional funding to complete the development of our product candidates, which may not be available on acceptable terms, if at all.” Business Our Product Candidates Crohn’s Disease, page 67 7. Please define scientific terms such as “anti-CD4 and TNF binding mABs” and tell us what you mean by “induction of apoptosis of activated T-lymphocytes rather than neutralization of soluble TNF.” Please also cite the referenced previously reported studies and provide support for your conclusion regarding TNF targeting mAbs in Crohn’s disease Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has added the requested definitions in-line on pages 67 and 68, and provided the requested explanation and cited the relevant studies and support on page 68. U.S. Securities and Exchange Commission August 23, 2018 Page 4 Proposed Phase 1 Clinical Trial for Foralumab for the Treatment of Multiple Sclerosis, page 70 8. In the second paragraph you indicate that Intravenous Foralumab was studied in three Phase 1 and Phase 2 clinical trials in 68 patients. In the third paragraph you indicate that 68 of the participants in the trials had Crohn’s disease and 11 had acute cellular allograft rejection. Please clarify the discrepancy. Additionally, for each trial, expand your disclosure to include the duration of the trial, primary and secondary endpoints and whether these endpoints were met, as well as all serious adverse events. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has revised the relevant disclosure on page 70. Milciclib (TZLS-201) Phase 1 Development, page 70 9. For each of your trials CDKO-125a-003 and CDKO 125a-004, please revise your disclosure to explain what you mean by “clinically significant” disease stabilization in terms of objective data points. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has removed references to clinical significance on page 75, and amended the disclosure accordingly. Research and Development, page 84 10. We note your references to Milciclib as having a “good safety profile” and demonstrated to be “efficacious.” Please revise your disclosure to remove these statements as determinations of safety and efficacy are solely within the authority of the U.S. Food and Drug Administration and comparable regulatory bodies. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has revised the relevant disclosure on page 84. Consolidated Statements of Shareholders’ Equity, page F-5 11. It is apparent that your 2016 and 2017 equity statements do not foot and cross-foot appropriately. Please revise these statements to correct the following footing and cross-footing discrepancies: ● 2017 Share Capital total transactions with owners subtotal does not foot; ● 2016 and 2017 Share Premium total transactions with owners subtotal does not foot; ● 2017 Convertible Loan Note Reserve total transactions with owners subtotal does not foot; ● Retained Earnings balance at December 31, 2016 does not foot; ● Translation Reserve balance at December 31, 2017 does not foot; ● 2017 Capital Reduction Reserve total transactions with owners subtotal does not foot; ● Capital Reduction Reserve at December 31, 2017 does not foot; ● 2016 and 2017 Total Equity for the transactions with owners subtotal does not foot; ● Total Equity balance at December 31, 2016 does not foot; and ● Total transactions with owners subtotal for both 2016 and 2017 does not cross-foot. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has corrected footing discrepancies on page F-5. U.S. Securities and Exchange Commission August 23, 2018 Page 5 Consolidated Statements of Cash Flows, page F-6 12. Please revise to label the beginning item in your presentation of cash flows from operating activities as Loss from operations before income taxes or revise to use the amount of the net loss for the periods presented. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has revised the Consolidated Statements of Cash Flows on page F-6. 11. Loss Per Share, page F-14 13. Please address the following comments regarding your loss per share computations: ● Explain to us why you appear to use your comprehensive loss in the numerator of your 2017 loss per share computation instead of your loss for the year. Otherwise, revise your computation and disclosure accordingly. ● As you classify the Convertible Loan Notes disclosed in Note 18 as equity, explain to us why the interest accrued on these notes is not treated similar to preferred dividends in the numerator of your loss per share computation consistent with the guidance in paragraphs 12 through 18 of IAS 33. Otherwise, revise your loss per share computations in 2016 and 2017 to reflect the interest accrued on these notes as a deduction in the numerator tantamount to a dividend on the underlying equity instruments. To the extent that you revise your loss per share computations, provide the error correction disclosure required by paragraph 49 of IAS 8. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has amended the numerator of the 2017 loss per share computation to be the loss for the year. Paragraphs 12 to 18 of IAS 33 require entities to make adjustments to earnings in respect of preference shares classified as equity in the calculation of basic earnings per share. Whilst it is noted that the Convertible Loan Notes have been classified as equity, these financial instruments are not preference shares and were not considered to be instruments similar in nature to preference shares. A preference share is, under UK company law a share, however the Convertible Loan Notes are not shares in law (until such time as these are exercised). Given the very specific reference to “preference shares” in IAS 33, it had not been considered appropriate to apply the requirements of paragraphs 12 to 18 by analogy to financial instruments which are not preference shares. However, in recognition of the Staff’s preference to apply the principle of paragraphs 12 to 18 to Convertible Loan Notes the Company has agreed with its auditors that the adjustment to the numerator of the loss per share calculation to include the interest accrued on Convertible Loan Notes can be made. Accordingly a note 2 includes an explanation of the prior period adjustment U.S. Securities and Exchange Commission August 23, 2018 Page 6 Notes to Consolidated Financial Statements 10. Taxation, page F-14 14. Please address the following comments regarding the income tax benefit reflected in your financial statements: ● Tell us why it is appropriate to reflect the benefits recorded and how they are realizable given your historical losses. ● Revise your disclosure to describe the basis for the Research and development claim provided in your reconciliation of your tax credit to the statutory rate. In addition, separately tell us how this claim is based on taxable profits to be recorded as an income tax benefit as stipulated in paragraph 2 of IAS 12 and why it is not reflected as a reduction of research and development expenses as indicated in the second paragraph on page 57. ● Revise your disclosure to describe the nature of the Adjustments due to prior periods included in your reconciliation of the tax credit to the statutory rate for 2017. Separately tell us why these adjustments are not the correction of errors that should be reflected in earlier periods under IAS 8. ● Revise your disclosure to include a discussion of the tax impact for the year in the Management’s Discussion and Analysis of Financial Condition and Results of Operations narrative on page 59. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has followed UK tax legislation and under the Small and Medium Sized Enterprises (SME) R&D relief it is able to claim a tax cash credit worth up to 14.5% of its surrenderable loss. The receipt of the cash tax credit is not linked to the future profitability of the business. The Company’s research and development claim is not based on taxable profits, but is based on qualifying expenditure incurred, as defined by UK tax legislation and has been recorded as an income tax benefit in accordance with IAS 12. The Company has amended the narrative on page 57 to reflect this position. The Company has revised its disclosure to describe the basis for the Research and development claim provided in the reconciliation of the tax credit to the statutory rate. In addition, the Company has revised its disclosure to describe the basis for the Adjustments due to prior periods claim provided in the reconciliation of the tax credit to the statutory rate. Un
2018-08-16 - UPLOAD - Tiziana Life Sciences Ltd
August 16, 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
Registration Statement on Form F-1
Filed July 26, 2018
File No. 333-226368
Dear Mr. Lazzaretti:
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 F-1
Cover page
1.We note your statement that no assurance can be given that your application to list your
American Depositary Shares on the Nasdaq Capital Market will be approved. If your
offering is not contingent on listing approval, please revise your cover page disclosure to
clarify this fact. Additionally, please include a risk factor describing the consequences of
not securing Nasdaq listing approval.
2.We note your disclosure that the last reported sale price of your ordinary shares on AIM
was £ ___ per ordinary share, equivalent to $ ___ per ADS. You may use the most recent
home market trading price, converted to U.S. dollars at the most recent exchange rate,
FirstName LastNameTiziano Lazzaretti
Comapany NameTiziana Life Sciences plc
August 16, 2018 Page 2
FirstName LastNameTiziano Lazzaretti
Tiziana Life Sciences plc
August 16, 2018
Page 2
assuming the U.S. IPO price will be substantially similar to the home market trading price.
If you expect that the U.S. IPO price will not be substantially similar to the home market
trading price, please disclose on the prospectus cover page a bona fide price range of the
offered securities. If you intend to price the securities based on the AIM market price, you
may disclose a percentage range based on that price (for example, 10% of the home
market price) within which you intend to price the securities. See Item 501(b)(3) of
Regulation S-K.
Prospectus Summary
Our Strategy, page 3
3.We note your statement that your goal is to deliver best-in-class and potentially life-
altering therapies. Given the development stage of your product candidates and length of
the drug approval process, it is premature and inappropriate for you to imply that any of
your product candidates will ultimately be approved or become best-in-class or life-
altering. Please remove this statement here and on page 65.
Our Product Candidates
Clinical Development Pipeline, page 4
4.We note your disclosure on page 1 that you plan to initially investigate Foralumab for
safety and its immunomodulatory activity in healthy volunteers in two Phase 1 trials.
Please revise your pipeline development chart to remove the studies conducted by
Novimmune for the intravenous formulation and ensure that it accurately reflects the
development status for your stated strategy. Additionally, with respect to references to the
studies conducted by Novimmune, please revise your disclosure to remove your
conclusions, i.e., “encouraging clinical response,” to reference objective data points from
which your conclusions were drawn.
Implications of Being an Emerging Growth Company, page 5
5.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Use of Proceeds, page 48
6.Please revise the Use of Proceeds discussion to quantify the amounts you expect to
allocate to Miliciclib and Foralumab separately. It appears from your disclosure that the
proceeds from the offering will not be sufficient to fund development of your product
candidates through regulatory approval and commercialization. Please indicate how far
the proceeds from the offering will allow you to proceed with the continued development
of Milciclib and Foralumab. Also disclose the sources of other funds needed to reach
FirstName LastNameTiziano Lazzaretti
Comapany NameTiziana Life Sciences plc
August 16, 2018 Page 3
FirstName LastNameTiziano Lazzaretti
Tiziana Life Sciences plc
August 16, 2018
Page 3
regulatory approval and commercialization for each product candidate. Refer to Item 3.C
of Form 20-F required by Item 4 of Form F-1.
Business
Our Product Candidates
Crohn’s Disease, page 67
7.Please define scientific terms such as “anti-CD4 and TNF binding mABs” and tell us what
you mean by “induction of apoptosis of activated T-lymphocytes rather than neutralization
of soluble TNF.” Please also cite the referenced previously reported studies and provide
support for your conclusion regarding TNF targeting mAbs in Crohn’s disease.
Proposed Phase 1 Clinical Trial for Foralumab for the Treatment of Multiple Sclerosis, page 70
8.In the second paragraph you indicate that Intravenous Foralumab was studied in three
Phase 1 and Phase 2 clinical trials in 68 patients. In the third paragraph you indicate that
68 of the partiicpants in the trials had Crohn’s disease and 11 had acute cellular allograft
rejection. Please clarify the discrepancy. Additionally, for each trial, expand your
disclosure to include the duration of the trial, primary and secondary endpoints and
whether these endpoints were met, as well as all serious adverse events.
Milciclib (TZLS-201)
Phase 1 Development, page 70
9.For each of your trials CDKO-125a-003 and CDKO 125a-004, please revise your
disclosure to explain what you mean by “clinically significant” disease stabilization in
terms of objective data points.
Research and Development, page 84
10.We note your references to Milciclib as having a “good safety profile” and demonstrated
to be “efficacious.” Please revise your disclosure to remove these statements as
determinations of safety and efficacy are solely within the authority of the U.S. Food and
Drug Administration and comparable regulatory bodies.
Consolidated Statements of Shareholders' Equity, page F-5
11.It is apparent that your 2016 and 2017 equity statements do not foot and cross-foot
appropriately. Please revise these statements to correct the following footing and cross-
footing discrepancies:
•2017 Share Capital total transactions with owners subtotal does not foot;
•2016 and 2017 Share Premium total transactions with owners subtotal does not foot;
•2017 Convertible Loan Note Reserve total transactions with owners subtotal does not
foot;
•Retained Earnings balance at December 31, 2016 does not foot;
FirstName LastNameTiziano Lazzaretti
Comapany NameTiziana Life Sciences plc
August 16, 2018 Page 4
FirstName LastNameTiziano Lazzaretti
Tiziana Life Sciences plc
August 16, 2018
Page 4
•Translation Reserve balance at December 31, 2017 does not foot;
•2017 Capital Reduction Reserve total transactions with owners subtotal does not foot;
•Capital Reduction Reserve at December 31, 2017 does not foot;
•2016 and 2017 Total Equity for the transactions with owners subtotal does not foot;
•Total Equity balance at December 31, 2016 does not foot; and
•Total transactions with owners subtotal for both 2016 and 2017 does not cross-foot.
Consolidated Statements of Cash Flows, page F-6
12.Please revise to label the beginning item in your presentation of cash flows from operating
activities as Loss from operations before income taxes or revise to use the amount of the
net loss for the periods presented.
11. Loss Per Share, page F-14
13.Please address the following comments regarding your loss per share computations:
•Explain to us why you appear to use your comprehensive loss in the numerator of your
2017 loss per share computation instead of your loss for the year. Otherwise, revise
your computation and disclosure accordingly.
•As you classify the Convertible Loan Notes disclosed in Note 18 as equity, explain to
us why the interest accrued on these notes is not treated similar to preferred dividends
in the numerator of your loss per share computation consistent with the the guidance in
paragraphs 12 through 18 of IAS 33. Otherwise, revise your loss per share
computations in 2016 and 2017 to reflect the interest accrued on these notes as
a deduction in the numerator tantamount to a dividend on the underlying equity
instruments.
To the extent that you revise your loss per share computations, provide the error
correction disclosure required by paragraph 49 of IAS 8.
Notes to Consolidated Financial Statements
10. Taxation, page F-14
14.Please address the following comments regarding the income tax benefit reflected in your
financial statements:
•Tell us why it is appropriate to reflect the benefits recorded and how they are
realizable given your historical losses.
•Revise your disclosure to describe the basis for the Research and development claim
provided in your reconciliation of your tax credit to the statutory rate. In addition,
separately tell us how this claim is based on taxable profits to be recorded as an
income tax benefit as stipulated in paragraph 2 of IAS 12 and why it is not reflected as
a reduction of research and development expenses as indicated in the second
paragraph on page 57.
•Revise your disclosure to describe the nature of the Adjustments due to prior periods
FirstName LastNameTiziano Lazzaretti
Comapany NameTiziana Life Sciences plc
August 16, 2018 Page 5
FirstName LastName
Tiziano Lazzaretti
Tiziana Life Sciences plc
August 16, 2018
Page 5
included in your reconciliation of the tax credit to the statutory rate for 2017.
Separately tell us why these adjustments are not the correction of errors that should be
reflected in earlier periods under IAS 8.
•Revise your disclosure to include a discussion of the tax impact for the year in the
Management's Discussion and Analysis of Financial Condition and Results of
Operations narrative on page 59.
General
15.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.
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 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 Mary Beth Breslin at 202-551-3625 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ed Lukins, Esq.
2018-05-24 - UPLOAD - Tiziana Life Sciences Ltd
May 24, 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
Amendment No. 5 to Draft Registration Statement on Form 20-F
Submitted May 10, 2018
CIK No. 0001723069
Dear Mr. Lazzaretti:
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. 5 to Draft Registration Statement on Form 20-F
Item 4. Information on the Company
B. Business Overview
Brigham and Women's Hospital License, page 70
1.Please expand your disclosure to include the aggregate potential milestone payments
under the license agreement.
FirstName LastNameTiziano Lazzaretti
Comapany NameTiziana Life Sciences plc
May 24, 2018 Page 2
FirstName LastName
Tiziano Lazzaretti
Tiziana Life Sciences plc
May 24, 2018
Page 2
General
2.Please update your financial statements and related disclosures throughout your
registration statement as required by Item 8.A.4 of Form 20-F.
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.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ed Lukins, Esq.
2018-03-13 - UPLOAD - Tiziana Life Sciences Ltd
March 12, 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
Amendment No. 4 to Draft Registration Statement on Form 20-F
Submitted February 27, 2018
CIK No. 0001723069
Dear Mr. Lazzaretti:
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. 4 to Draft Registration Statement on Form 20-F
Notes to Consolidated Financial Statements
16. Share Capital, page F-18
1.
We acknowledge your response to prior comment 5. It is unclear to us whether the order
from the High Court of England and Wales (the Order) as it relates to a credit to retained
earnings is made in the context of generally accepted accounting principles in the United
Kingdom (UK GAAP) or IFRS and/or whether “retained earnings” is a defined term under
either UK GAAP or IFRS. Although we acknowledge that the capital reduction resulting
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Comapany NameTiziana Life Sciences plc
June 16, 2017 Page 2
FirstName LastName
Tiziano Lazzaretti
Tiziana Life Sciences plc
March 12, 2018
Page 2
from the Order created distributable reserves, we continue to have concerns that
characterizing $41.3 million of capital contributed by shareholders as “retained earnings”
is a faithful representation of the transaction. Please address the following:
•Tell us if “retained earnings” is defined under UK GAAP.
•Tell us whether the Order applies to UK GAAP financial statements or IFRS financial
statements.
•If you are able to support that the Order applies to your IFRS financial statements, tell
us whether the High Court regularly makes determination of accounting classification
under IFRS or whether it merely approved the underlying general objective of your
capital reduction transaction to create distributable reserves.
•Tell us your consideration for presenting your distributable reserves in two separate
columns on your statements of shareholders’ equity (one for distributable reserves
converted from contributed capital and the other from your results of operations) and
your consideration for titling the contributed capital component to anything other than
“retained earnings.”
21. Reserves, page F-23
2.Please confirm whether the £41.3 million of distributable reserves disclosed on page F-24
is denominated in GBP or USD, as indicated in your Consolidate Statements of
Shareholders' Equity on page F-5, and revise accordingly.
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.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ed Lukins, Esq.
2018-02-22 - UPLOAD - Tiziana Life Sciences Ltd
February 21, 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
Amendment No. 1 to Draft Registration Statement on Form 20-F
Submitted February 8, 2018
Amendment No. 2 to Draft Registration Statement on Form 20-F
Submitted February 9, 2018
CIK No. 0001723069
Dear Mr. Lazzaretti:
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. 2 to DRS Form 20-F submitted on February 9, 2018
Item 4. Information on the Company
B. Business Overview
Our Product Candidates, page 51
1.We note your response to comment 3. However, you continue to indicate that the product
candidates are safe, that the trials have demonstrated safety and that you will make
determinations with respect to safety. The determination that a product candidate is safe
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June 16, 2017 Page 2
FirstName LastNameTiziano Lazzaretti
Tiziana Life Sciences plc
February 21, 2018
Page 2
is within the exclusive authority of the FDA and comparable foreign regulatory entities,
and is continually assessed during all phases of clinical trials. If accurate, you may state
that your product candidates were well tolerated or that there were no serious adverse
events relating to the product candidates observed during the trial. Alternatively, you may
present data related to adverse events observed as evidence of safety. For example:
•Page 53: "If safe, a high dose of 5mg/dose will be administered orally further for 5
consecutive days followed by 10 days of safety monitoring. If data indicates that the
drug is safe, Phase IIa trials will be administered.
•Page 62: "Monotherapy treatment regimen with milciclib ... was safe and well
tolerated ...seven patients ... have been continuing treatment with milciclib for more
than 2 years with excellent safety profile. Among these, 2 patients have been treated
with milciclib for approximately 5 years, demonstrating safety of the drug for long
term treatment."
Milciclib, page 56
2.We note your response to comment 7, which we reissue in part. Please tell us why you
report the number of patients on page 61 as approximate.
Phase II Data in Thymoma and Thymic Carcinoma, page 62
3.We note your response to comment 9, which we reissue in part. Please explain the
meaning of "clinically interesting" in this context.
Collaborations and License Agreements, page 66
4.Refer to your response to our prior comment 12. As previously requested, please provide
us your analysis of the Nerviano Option to repurchase shares, which should include a
description of terms, your determination of accounting treatment for the option, and the
specific accounting guidance on which you relied.
Notes to Consolidated Financial Statements
16. Share Capital, page F-18
5.We acknowledge your response to prior comment 19. Although you indicate that the
$41.3 million credit resulting from your capital reduction is distributable and was recorded
in retained earnings in accordance with normal accounting practice in the U.K., paragraph
15 of IAS 1 requires the representationally faithful presentation of transactions in the
financial statements. We believe that there is no specific prohibition in IFRS from
presenting this transaction in a separate reserve and that its commingling with your
historical operating results in "retained earnings" is not representationally faithful. As a
result, please revise your presentation to reclassify this capital reduction transaction from
your retained earnings to some other capital reserve and revise your footnote disclosure to
indicate the impact of this new capital reserve on your dividend paying capacity.
FirstName LastNameTiziano Lazzaretti
Comapany NameTiziana Life Sciences plc
June 16, 2017 Page 3
FirstName LastName
Tiziano Lazzaretti
Tiziana Life Sciences plc
February 21, 2018
Page 3
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.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ed Lukins, Esq.
2018-01-22 - UPLOAD - Tiziana Life Sciences Ltd
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
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June 16, 2017 Page 2
FirstName LastNameTiziano Lazzaretti
Tiziana Life Sciences plc
January 19, 2018
Page 2
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
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June 16, 2017 Page 3
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Tiziana Life Sciences plc
January 19, 2018
Page 3
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
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Comapany NameTiziana Life Sciences plc
June 16, 2017 Page 4
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Tiziana Life Sciences plc
January 19, 2018
Page 4
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:
oyou present translation income/loss in your consolidated statements of
shareholders' equity that is in addition to that presented in this statement; and
otherefore, 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
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Tiziano Lazzaretti
Tiziana Life Sciences plc
January 19, 2018
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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.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ed Lukins, Esq.
2017-12-06 - UPLOAD - Tiziana Life Sciences Ltd
December 6, 2017
Kunwar Shailubhai
Chief Executive 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
Filed November 30, 2017
File No. 377-01809
Dear Mr. Shailubhai:
Our preliminary review of your draft registration statement indicates that it fails in
numerous material respects to comply with the requirements of the form. For instance, we note
the audit report is not dated. Further, you indicate in Note 2 on page F-7 that your financial
statements have been prepared in accordance with IFRS as adopted by the European Union,
IFRIC interpretations and the Companies Act of 2006. Your auditors indicate in their report on
page F-2 that your financial statements are presented fairly, in all material respects, in
conformity with U.S. generally accepted accounting principles (US GAAP). In order to provide
financial statements without reconciliation to US GAAP, please revise your filing to provide
financial statements and an audit report that consistently refer to IFRS as issued by the IASB as
stipulated in Item 17(c) of Form 20-F. Finally, we note that while the Balance Sheet dated June
30, 2017 on page F-3 indicates the line items are written in the thousands, the cash and cash
equivalent line item is not. Accordingly, we will not perform a detailed examination of the draft
registration statement and we will not issue comments.
You may submit a substantive amendment to correct the deficiencies. Please contact
Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-3625 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ed Lukins, Esq.