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Sol-Gel Technologies Ltd.
Response Received
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Sol-Gel Technologies Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-03-17
Sol-Gel Technologies Ltd.
Summary
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Company responded
2023-05-03
Sol-Gel Technologies Ltd.
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Sol-Gel Technologies Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-04-08
Sol-Gel Technologies Ltd.
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2022-04-11
Sol-Gel Technologies Ltd.
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Sol-Gel Technologies Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-04-04
Sol-Gel Technologies Ltd.
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2019-04-10
Sol-Gel Technologies Ltd.
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Sol-Gel Technologies Ltd.
Response Received
4 company response(s)
High - file number match
Company responded
2017-09-01
Sol-Gel Technologies Ltd.
References: October 26, 2016
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SEC wrote to company
2017-09-11
Sol-Gel Technologies Ltd.
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Company responded
2018-01-17
Sol-Gel Technologies Ltd.
References: January 12, 2018
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Company responded
2018-01-29
Sol-Gel Technologies Ltd.
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2018-01-29
Sol-Gel Technologies Ltd.
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Sol-Gel Technologies Ltd.
Awaiting Response
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High
SEC wrote to company
2018-01-29
Sol-Gel Technologies Ltd.
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Sol-Gel Technologies Ltd.
Awaiting Response
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High
SEC wrote to company
2018-01-16
Sol-Gel Technologies Ltd.
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Sol-Gel Technologies Ltd.
Orphan - no UPLOAD in window
1 company response(s)
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Company responded
2017-12-29
Sol-Gel Technologies Ltd.
References: September 11, 2017
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Sol-Gel Technologies Ltd.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-08-28
Sol-Gel Technologies Ltd.
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Company responded
2017-08-29
Sol-Gel Technologies Ltd.
References: August 28, 2017
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Sol-Gel Technologies Ltd.
Awaiting Response
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Medium
SEC wrote to company
2017-05-01
Sol-Gel Technologies Ltd.
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Sol-Gel Technologies Ltd.
Awaiting Response
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Medium
SEC wrote to company
2016-10-27
Sol-Gel Technologies Ltd.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-06 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2025-05-02 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | 333-286822 | Read Filing View |
| 2023-05-03 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2023-03-17 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2022-04-11 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2022-04-08 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2019-04-10 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2019-04-04 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2018-01-29 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2018-01-29 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2018-01-29 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2018-01-17 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2018-01-16 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-12-29 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-09-11 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-09-01 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-08-29 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-08-28 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-05-01 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2016-10-27 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-02 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | 333-286822 | Read Filing View |
| 2023-03-17 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2022-04-08 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2019-04-04 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2018-01-29 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2018-01-16 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-09-11 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-08-28 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-05-01 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2016-10-27 | SEC Comment Letter | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-06 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2023-05-03 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2022-04-11 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2019-04-10 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2018-01-29 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2018-01-29 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2018-01-17 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-12-29 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-09-01 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
| 2017-08-29 | Company Response | Sol-Gel Technologies Ltd. | Israel | N/A | Read Filing View |
2025-05-06 - CORRESP - Sol-Gel Technologies Ltd.
CORRESP 1 filename1.htm May 6, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill Re: Sol-Gel Technologies Ltd. Registration Statement on Form F-3 Filed April 29, 2025 File No. 333-286822 (the “Registration Statement”) Acceleration Request Ladies and Gentlemen: In accordance with Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, Sol-Gel Technologies Ltd. (the “Registrant”) hereby respectfully requests that the Securities and Exchange Commission accelerate the effective date of the above-referenced Registration Statement to Thursday, May 8, 2025 at 4:01 p.m., Eastern Time, or as soon as thereafter practicable. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please contact Jeffrey Schultz of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (212) 692-6732 with any questions regarding this request. Very truly yours, SOL-GEL TECHNOLOGIES LTD. By: /s/ Eyal Ben-Or Name: Eyal Ben-Or Title: CFO cc: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Jeffrey Schultz, Esq.
2025-05-02 - UPLOAD - Sol-Gel Technologies Ltd. File: 333-286822
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 2, 2025 Moshe Arkin Interim Chief Executive Officer Sol-Gel Technologies Ltd. 7 Golda Meir Street Weizmann Science Park Ness Ziona, 7403650, Israel Re: Sol-Gel Technologies Ltd. Registration Statement on Form F-3 Filed April 29, 2025 File No. 333-286822 Dear Moshe Arkin: 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 Lauren Hamill at 303-844-1008 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jeffrey Schultz </TEXT> </DOCUMENT>
2023-05-03 - CORRESP - Sol-Gel Technologies Ltd.
CORRESP
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Sol-Gel Technologies Ltd.
7 Golda Meir St., Weizmann Science Park
Ness Ziona, 7403648, Israel
May 3, 2023
Via EDGAR Transmission
Tyler Howes
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Sol-Gel Technologies Ltd.
Registration Statement on Form F-1
Filed March 10, 2023
Registration No. 333-270478
Dear Mr. Howes:
In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request the acceleration of the effective
date of the above-referenced Registration Statement so that it will become effective on May 5, 2023 at 4:00 p.m. Eastern Time or as soon thereafter as practicable, or at such later time as Sol-Gel Technologies Ltd. (the “Company”) or its
counsel may request via telephone call to the staff. Please contact Nathan Ajiashvili of Latham & Watkins LLP, counsel to the Company, at (212) 906-2916, or in his absence, Salvatore Vanchieri at (212) 906-4605, to provide notice of
effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely yours,
Sol-Gel Technologies Ltd.
By:
/s/ Gilad Mamlok
Gilad Mamlok
Chief Financial Officer
cc:
Nathan Ajiashvili, Latham & Watkins LLP
Salvatore Vanchieri, Latham & Watkins LLP
Perry Wildes, Goldfarb Gross Seligman & Co.
2023-03-17 - UPLOAD - Sol-Gel Technologies Ltd.
United States securities and exchange commission logo
March 17, 2023
Alon Seri-Levy, Ph.D.
Chief Executive Officer
Sol-Gel Technologies Ltd.
7 Golda Meir St.
Weizmann Science Park
Ness Ziona, 7403648, Israel
Re:Sol-Gel Technologies Ltd.
Registration Statement on Form F-1
Filed March 10, 2023
File No. 333-270478
Dear Alon Seri-Levy:
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 Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Salvatore Vanchieri, Esq.
2022-04-11 - CORRESP - Sol-Gel Technologies Ltd.
CORRESP
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Sol-Gel Technologies Ltd.
7 Gold Meir St., Weizmann Science Park
Ness Ziona, 7403650, Israel
April 11, 2022
Via EDGAR Transmission
Tim Buchmiller
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Sol-Gel Technologies Ltd.
Registration Statement on Form F-3
Filed April 7, 2022
Registration No. 333-264190
Dear Mr. Buchmiller:
In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933,
as amended, we hereby request the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on April 13, 2022 at 4:00 p.m. Eastern Time or as soon thereafter as practicable, or at such later
time as Sol-Gel Technologies Ltd. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Nathan Ajiashvili of Latham
& Watkins LLP, counsel to the Company, at (212) 906-2916, or in his absence, Salvatore Vanchieri at (212) 906-4605, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely yours,
Sol-Gel Technologies Ltd.
By:
/s/ Gilad Mamlok
Gilad Mamlok
Chief Financial Officer
cc: Nathan Ajiashvili, Latham & Watkins LLP
Perry Wildes, Gross & Co.
2022-04-08 - UPLOAD - Sol-Gel Technologies Ltd.
United States securities and exchange commission logo
April 8, 2022
Alon Seri-Levy, Ph.D.
Chief Executive Officer
Sol-Gel Technologies Ltd.
7 Golda Meir St.
Weizmann Science Park
Ness Ziona, 7403650, Israel
Re:Sol-Gel Technologies Ltd.
Registration Statement on Form F-3
Filed April 7, 2022
File No. 333-264190
Dear Dr. Seri-Levy:
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: Nathan Ajiashvili, Esq.
2019-04-10 - CORRESP - Sol-Gel Technologies Ltd.
CORRESP 1 filename1.htm Sol-Gel Technologies Ltd. 7 Gold Meir St., Weizmann Science Park Ness Ziona, 7403650, Israel April 10, 2019 Via EDGAR Transmission Tonya K. Aldave, Esq. Division of Corporation Finance Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Sol-Gel Technologies Ltd. Registration Statement on Form F-3 Filed March 28, 2019 Registration No. 333-230564 Dear Ms. Aldave: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on April 12, 2019 at 4:00 p.m. Eastern Time or as soon thereafter as practicable, or at such later time as Sol-Gel Technologies Ltd. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Nathan Ajiashvili of Latham & Watkins LLP, counsel to the Company, at (212) 906-2916, or in his absence, Salvatore Vanchieri at (212) 906-4605, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Sincerely yours, Sol-Gel Technologies Ltd. By: /s/ Gilad Mamlok Gilad Mamlok Chief Financial Officer cc: Nathan Ajiashvili, Latham & Watkins LLP Perry Wildes, Gross, Kleinhendler, Hodak, Halevy, Greenberg, Shenhav & Co.
2019-04-04 - UPLOAD - Sol-Gel Technologies Ltd.
April 2, 2019
Gilad Mamlok
Chief Financial Officer
Sol-Gel Technologies Ltd.
7 Golda Meir Street
Weizmann Science Park
Ness Ziona, 7403650, Israel
Re:Sol-Gel Technologies Ltd.
Registration Statement on Form F-3
Filed March 28, 2019
File No. 333-230564
Dear Mr. Mamlok:
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 Tonya K. Aldave at (202) 551-3601 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Nathan Ajiashvili, Esq.
2018-01-29 - UPLOAD - Sol-Gel Technologies Ltd.
Mail Stop 4546 January 29, 201 8 Alon Seri -Levy Chief Executive Officer Sol-Gel Technologies Ltd. 7 Golda Meir St., Weizmann Science Park Ness Ziona, 7403648, Israel Re: Sol-Gel Technologies Ltd. Amendment No. 4 to Registration Statement on Form F -1 Filed January 23 , 2018 File No. 333-220234 Dear Mr. Seri -Levy : We have reviewed your amended registration statement and have the following comment. 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 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 this comment, we may have additional comme nts. Management’s Discussion and Analysis of Financial Condition and Results of Operations Collaboration Agreements, page 69 1. We note your response to our comment issued on January 12, 2018 and note that you received the in -process research and development product candidate from a related party. Pursuant to the transfer of this product candidate from Arkin Dermatology to you, you assumed the obligation for 80% of the clinical study costs. Additionally, we note yo ur disclosure that $5.8 million of an $8.3 million increase on research and development expenses for the nine months ended September 30, 2017 was related to the acquis ition of an in-process research and development product candidate. Please present further analysis regarding a requireme nt to file the agreement pursuant to Item 601(b)(10)(ii)(A). Alon Seri -Levy Sol-Gel Technologies Ltd. January 29, 201 8 Page 2 You may contact Ibolya Ignat at (202) 551 -3636 or Angela Connell at (202) 551 -3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at (202) 551 -2544 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare & Insurance cc: Nathan Ajiashvili , Esq. Latham & Watkins LLP
2018-01-29 - CORRESP - Sol-Gel Technologies Ltd.
CORRESP
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Sol-Gel Technologies Ltd.
7 Golda Meir St., Weizmann Science Park
Ness Ziona, 7403648, Israel
January 29, 2018
Via EDGAR Transmission
Ms. Suzanne Hayes
Assistant Director
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Re: Sol-Gel Technologies
Ltd.
Registration Statement on
Form F-1 Filed on August 29, 2017, as amended on September 6, 2017, September 20, 2017, December 29, 2017 and January 23, 2018
File No. 333-220234
Dear Ms. Hayes:
In accordance with
Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request the
acceleration of the effective date of the above referenced Registration Statement so that it will become effective on January 31,
2018, at 4:00 p.m. Eastern Daylight Time, or as soon thereafter as practicable, or at such later time as Sol-Gel Technologies Ltd.
(the “Company”) or its counsel may request via telephone call to the staff.
In connection with
this request for acceleration of the effective date of the Registration Statement, the Company acknowledges the following:
· should the Securities and Exchange Commission (the “Commission”) or the staff,
acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action
with respect to the filing;
· the action of the Commission or the staff, acting pursuant to delegated authority, in declaring
the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure
in the filing; and
· the Company may not assert staff comments and the declaration of effectiveness as a defense in
any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please contact Nathan
Ajiashvili of Latham & Watkins LLP, counsel to the Company, at (212) 906-2916, or in his absence, John Slater at (212) 906-1675,
to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely yours,
Sol-Gel Technologies Ltd.
By:
/s/ Alon Seri-Levy
Name: Alon Seri-Levy
Title: Chief Executive Officer
cc: Joshua Kiernan, Latham & Watkins LLP
Nathan Ajiashvili, Latham &
Watkins LLP
Gene Kleinhendler, Gross, Kleinhendler,
Hodak, Halevy, Greenberg & Co.
2018-01-29 - CORRESP - Sol-Gel Technologies Ltd.
CORRESP
1
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January 29, 2018
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 4720
100 F Street, N.E.
Washington, D.C. 20549
Attn: Ms. Suzanne Hayes
Re:
Sol-Gel Technologies Ltd.
Registration Statement on Form F-1
File No. 333-220234
Request for Acceleration
Dear Ms. Hayes:
Pursuant to Rule 461 under the Securities Act of 1933, as amended,
the undersigned, as the representatives of the prospective underwriters of the above issue, hereby join in the request of Sol-Gel
Technologies Ltd. (the “Company”) that the effectiveness of the Registration Statement on Form F-1 (Registration No.
333-220234) be accelerated so that the Registration Statement will become effective at 4:00 P.M. Eastern Time on January 31, 2018,
or as soon thereafter as practicable, or at such later time as the Company or its counsel may request via telephone call to the
staff.
Pursuant to Rule 460 under the Securities Act of 1933, as amended, and in connection with the foregoing, please note that the underwriters
have effected approximately the following distribution of the Company’s preliminary prospectus dated January 23, 2018, between
January 23, 2018 and the date hereof:
1,016 copies to institutions;
0 copies to prospective underwriters; and
0 copies to others.
The undersigned, as the representatives of the prospective underwriters
of the above issue, hereby represent on behalf of the underwriters that the underwriters are acting in compliance and will act
in compliance with the provisions of Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection
with the above proposed offering.
[Remainder of Page
Intentionally Left Blank; Signature Page Follows]
Very truly yours,
JEFFERIES LLC
BMO CAPITAL MARKETS CORP.
By: JEFFERIES LLC
By:
/s/ Gil Bar-Nahum
Name:
Gil Bar-Nahum
Title:
Managing Director
By: BMO CAPITAL MARKETS CORP.
By:
/s/ Helen Oesch
Name:
Helen Oesch
Title:
Managing Director
[Signature Page to Acceleration Request]
2018-01-17 - CORRESP - Sol-Gel Technologies Ltd.
CORRESP
1
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53rd at Third
885 Third Avenue
New York, New York 10022-4834
Tel: +1.212.906.1200 Fax: +1.212.751.4864
www.lw.com
FIRM / AFFILIATE OFFICES
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January 17, 2018
VIA EDGAR AND HAND DELIVERY
Ms. Suzanne Hayes
Assistant Director
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E
Washington, D.C. 20549
Re: Sol-Gel Technologies Ltd.
Amendment No. 3 to Registration
Statement on Form F-1
Filed December 29, 2017
File No. 333-220234
Dear Ms. Hayes:
On behalf of Sol-Gel Technologies Ltd.
(the “Company”), we are transmitting this letter in response to the comment received from the staff
(the “Staff”) of the Securities and Exchange Commission (the
“Commission”) by letter dated January 12, 2018 with respect to Amendment No. 3 to the
Company’s Registration Statement on Form F-1 (the “Registration Statement”) filed on December
29, 2017. The bold and numbered paragraph below corresponds to the numbered paragraph in the Staff’s letter and is
followed by the Company’s response. For the Staff’s convenience, we are also sending, by courier, copies of this
letter.
Management’s Discussion and Analysis of Financial
Condition and Results of Operations
Collaboration Agreements, page 68
1. We note that on August 22, 2017, you received an in-process research and development product candidate from a related party
together with an agreement with a third party for the development, manufacturing, and commercialization of the product. Please
expand your disclosure, here and elsewhere, to identify the product and collaborative partner. Additionally, disclose the material
terms of the agreement, such as the duration, termination provisions, and each party’s rights and obligations. File the agreement
as an exhibit or provide an analysis supporting your determination that you are not required to file it pursuant to Item 601(b)(10)
of Regulation S-K.
January 17, 2018
Page 2
Response: The Company acknowledges the Staff’s
comment and will disclose the material rights and obligations under the agreement in a subsequent amendment. The Company respectfully
advises the Staff that it will also disclose in a subsequent amendment that the collaborative partner is Perrigo UK Finco Limited
Partnership (“Perrigo”) and that the agreement (the “2017 Perrigo Agreement”) relates to the development
of a generic product candidate.
The Company respectfully submits that it is not required
to file the 2017 Perrigo Agreement. Item 601(b)(10)(i) of Regulation S-K defines a material contract, in relevant part, as a “contract
not made in the ordinary course of business which is material to the registrant.” Accordingly, for contracts outside the
ordinary course, the appropriate standard is whether the contract is material.
However, under Item 601(b)(10)(ii), registrants need
not file a contract if “the contract is such as ordinarily accompanies the kind of business conducted by the registrant,”
unless it falls into one or more of the categories specified therein.
We would note that the 2017 Perrigo Agreement is one
that ordinarily accompanies the business of the Company, and therefore only needs to be filed if within one of the specified categories
referred to in Item 601(b)(10)(ii). The only relevant potential category is clause (B), which requires the filing of any contract
“upon which the registrant’s business is substantially dependent.”
The Company’s business is not “substantially
dependent” on the 2017 Perrigo Agreement. The Company does not view the generic product candidate being developed in collaboration
with Perrigo UK under this agreement as material to its business, results of operations, prospects or financial condition. The
Company does not expect to incur material expenses in the development of this generic product candidate in the future. In addition,
the underwriters in the Company’s proposed initial public offering have not considered this generic product candidate or
the existence of the 2017 Perrigo Agreement as a material factor in determining the Company’s preliminary valuation. Accordingly,
because the Company is not “substantially dependent” on the 2017 Perrigo Agreement, such agreement is not required
to be filed pursuant to Item 601(b)(10)(ii).
If you have any questions regarding
the foregoing response, please do not hesitate to contact me by telephone at (212) 906-2916.
January 17, 2018
Page 3
Very truly yours,
/s/ Nathan Ajiashvili
Nathan Ajiashvili
of LATHAM & WATKINS LLP
cc: Alon Seri-Levy, Chief Executive Officer, Sol-Gel Technologies Ltd.
Joshua Kiernan, Latham & Watkins
LLP
Gene Kleinhendler, Gross, Kleinhendler,
Hodak, Halevy, Greenberg & Co.
2018-01-16 - UPLOAD - Sol-Gel Technologies Ltd.
Mail Stop 4546 January 12 , 201 8 Alon Seri -Levy Chief Executive Officer Sol-Gel Technologies Ltd. 7 Golda Meir St., Weizmann Science Park Ness Ziona, 7403648, Israel Re: Sol-Gel Technologies Ltd. Amendment No. 3 to Registration Statement on Form F -1 Filed December 29, 2017 File No. 333-220234 Dear Mr. Seri -Levy : We have reviewed your amended registration statement and have the following comment. 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 y our response. After reviewing any amendment to your registration statement and the information you provide in response to this comment, we may have additional comments. Management’s Discussion and Analysis of Financial Condition and Results of Operat ions Collaboration Agreements, page 68 1. We note that on August 22, 2017, you received an in -process research and development product candidate from a related party together with an agreement with a third party for the development, manufacturing, and commer cialization of the product. Please expand your disclosure, here and elsewhere, to identify the product and collaborative partner. Additionally, disclose the material terms of the agreement, such as the duration, termination provisions, and each party’s r ights and obligations. File the agreement as an exhibit or provide an analysis supporting your determination that you are not required to file it pursuant to Item 601(b)(10) of Regulation S -K. Alon Seri -Levy Sol-Gel Technologies Ltd. January 12 , 201 8 Page 2 You may contact Ibolya Ignat at (202) 551 -3636 or Angela Connell at (202) 551 -3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at (202) 551 -2544 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare & Insurance cc: Nathan Ajiashvili , Esq. Latham & Watkins LLP
2017-12-29 - CORRESP - Sol-Gel Technologies Ltd.
CORRESP
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53rd
at Third
885
Third Avenue
New
York, New York 10022-4834
Tel:
+1.212.906.1200 Fax: +1.212.751.4864
www.lw.com
FIRM
/ AFFILIATE OFFICES
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December 29, 2017
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VIA EDGAR AND HAND DELIVERY
Ms. Suzanne Hayes
Assistant Director
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E
Washington, D.C. 20549
Re: Sol-Gel Technologies Ltd.
Registration Statement on Form
F-1
(CIK No. 0001684693)
Dear Ms. Hayes:
On behalf of Sol-Gel Technologies Ltd.
(the “Company”), we are transmitting this letter in response to the comment received from the staff
(the “Staff”) of the Securities and Exchange Commission (the “Commission”)
by letter dated September 11, 2017 with respect to the Company’s Registration Statement on Form F-1 (the “Registration
Statement”). This letter is being submitted together with a copy of Amendment No. 3 to the Registration Statement
on Form F-1, which was filed on EDGAR on December 29, 2017 and revises the Registration Statement to address
the Staff’s comment (the “Amended Registration Statement”). The bold and numbered paragraph below
corresponds to the numbered paragraph in the Staff’s letter and is followed by the Company’s response. For the Staff’s
convenience, we are also sending, by courier, copies of this letter and marked copies of the Amended Registration Statement that
reflect changes made to the Registration Statement.
Prospectus
Pages 2 and 81
1. Please revise your added disclosure on page 2 and 81 to remove the reference to “favorable safety
profile.” A safety determination is exclusively a FDA determination.
December
29, 2017
Page 2
Response: The Company acknowledges the Staff’s
comment and has revised the disclosure in the Amended Registration Statement on pages 2 and 81.
If you have any questions regarding
the foregoing response or the enclosed Amended Registration Statement, please do not hesitate to contact me by telephone at (212)
906-2916.
Very truly yours,
/s/ Nathan Ajiashvili
Nathan Ajiashvili
of LATHAM & WATKINS LLP
cc: Alon Seri-Levy, Chief Executive Officer, Sol-Gel Technologies
Ltd.
Joshua Kiernan, Latham & Watkins
LLP
Gene Kleinhendler, Gross, Kleinhendler,
Hodak, Halevy, Greenberg & Co.
2017-09-11 - UPLOAD - Sol-Gel Technologies Ltd.
Mail Stop 4546 September 11, 2017 Alon Seri -Levy Chief Executive Officer Sol-Gel Technologies Ltd. 7 Golda Meir St., Weizmann Science Park Ness Ziona, 7403648, Israel Re: Sol-Gel Technologies Ltd. Registration Statement on Form F -1 Filed August 29 , 2017 File No. 333-220234 Dear Mr. Seri -Levy : We have reviewed your registration statement and have the following comment. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comment appl ies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewi ng any amendment to your registration statement and the information you provide in response to this comment, we may have additional comments. Prospectus Summary Overview, Page 1 1. Please revise your added disclosure on page 2 and 81 to remove the referen ce to “favorable safety profile.” A safety determination is exclusively a FDA determination. Alon Seri -Levy Sol-Gel Technologies Ltd. September 11 , 2017 Page 2 You may contact Ibolya Ignat at (202) 551 -3636 or Angela Connell at (202) 551 -3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at (202) 551 -2544 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthca re & Insurance cc: Nathan Ajiashvili , Esq. Latham & Watkins LLP
2017-09-01 - CORRESP - Sol-Gel Technologies Ltd.
CORRESP
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filename1.htm
53rd at Third
885 Third Avenue
New York, New York 10022-4834
Tel: +1.212.906.1200 Fax: +1.212.751.4864
www.lw.com
FIRM / AFFILIATE OFFICES
Barcelona
Moscow
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FOIA CONFIDENTIAL TREATMENT REQUEST
UNDER
17 C.F.R. §200.83
The entity requesting confidential treatment is:
Sol-Gel Technologies Ltd.
7 Golda Meir St., Weizmann Science Park
Ness Ziona, 7403648, Israel
Attn: Alon Seri-Levy, Chief Executive Officer
Phone Number: +972-8-931-3433
September 1, 2017
VIA EDGAR AND HAND DELIVERY
CONFIDENTIAL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention:
Suzanne Hayes, Assistant Director
Ibolya Ignat
Angela Connell
Jeffrey Gabor
Re: Sol-Gel Technologies Ltd. | Anticipated Price Range and Share-Based Compensation | Registration Statement on Form F-1 (File
No. 333-220234)
Dear Ms. Hayes:
On behalf of Sol-Gel
Technologies Ltd. (the “Company”), we submit this letter (this “Letter”) to
the Staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission
(the “Commission”). The Company confidentially submitted a draft of the above-referenced Registration
Statement (the “Registration Statement”) to the Commission on September 28, 2016, resubmitted to the
Commission on April 3, 2017, June 6, 2017 and August 11, 2017, and subsequently filed the Registration Statement with the Commission
on August 29, 2017. The purpose of this Letter is to respond to an outstanding comment relating to share-based compensation that
was provided to the Company in a letter from the Staff dated October 26, 2016. Because of the commercially sensitive nature of
the information contained herein, this submission is accompanied by the Company’s request for confidential treatment of selected
portions of this letter pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83.
A redacted letter has been filed on EDGAR, omitting the confidential information contained in the Letter.
September 1, 2017
Page 2
For the convenience
of the Staff, we are providing to the Staff copies of this Letter by hand delivery. In this Letter, we have recited the prior comment
from the Staff in italicized, bold type and have followed the comment with the Company’s response.
15. Once you
have an estimated offering price or range, please explain to us how you determined the fair value of the common stock underlying
your equity issuances and the reasons for any differences between the recent valuations of your common stock leading up to the
IPO and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances
including stock compensation and beneficial conversion features.
ESTIMATED IPO PRICE
RANGE
The
Company supplementally advises the Staff that, while not yet reflected in the Registration Statement, based on discussions with
the Company’s management and its board of directors (collectively, the “Board”) and reflecting
the input from the lead underwriters (the “Underwriters”) for the Company’s proposed initial public
offering of its ordinary shares (“IPO”), if the Company were to commence marketing of the transaction
today, the Company presently anticipates that the estimated price range would be approximately $[*] to $[*] per share (the
“Preliminary IPO Price Range”), with a midpoint of approximately $[*] per share (the “Preliminary
Assumed IPO Price”), before giving effect to an anticipated share split. The Company advises the Staff that the final
range to be included in a pre-effective amendment to the Registration Statement will include a price range of no more than $2.00,
if the maximum price is $10.00 per share or less, or 20% of the high end of the range, if the maximum price is greater than $10.00
per share, unless otherwise approved by the Staff.
The
Company’s final Preliminary IPO Price Range remains under discussion between the Company and the Underwriters, and
a bona fide price range will be included in an amendment to the Registration Statement prior to any distribution of the preliminary
prospectus in connection with the Company’s road show.
ANALYSIS OF SHARE OPTION GRANTS IN PRECEDING
12 MONTHS
The Company’s
discussion of share-based compensation for financial reporting purposes is primarily contained within the section of the Registration
Statement entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Significant
Accounting Policies and Estimates—Share-Based Compensation” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations—Significant Accounting Policies and Estimates—Options Valuation,”
which sections are included on pages 76 to 79 of the Registration Statement. As disclosed, the exercise price at which the
Company’s options could be exercised into ordinary shares was determined at the applicable date of grant by the Company’s
management and approved by the Board. The establishment of the exercise price was done for business reasons and not to establish
the fair value of the Company’s ordinary shares. The following table summarizes by grant date the number of ordinary shares
underlying share options granted during the 12 months preceding the date of this Letter, as well as the associated exercise price
per share and the estimated fair value per share to determine share-based compensation expense for financial reporting purposes.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY Sol-Gel Technologies Ltd.
September 1, 2017
Page 3
Grant Date
Shares Underlying
Options Granted
Exercise Price
Per Ordinary
Share
Estimated Fair
Value Per
Share
February 12, 2017
29,906
$ 2.86
$ 36.84
July 13, 2017
15,040
$ 2.86
$ 43.87
July 13, 2017
211,470
$ 10.02
$ 43.87
August 22, 2017
70,500
$ 10.02
$ 43.87
The
Company has determined the fair value of $43.87 per share, for the July 2017 and August 2017 grants. The Company has not
made any equity awards since August 22, 2017. The Company does not expect that any additional awards will be granted prior to the
IPO and any awards granted in connection with the IPO will have an exercise price equal to the initial public offering price per
ordinary share sold in the IPO pursuant to the Registration Statement.
Ordinary Share Valuation Methodologies
The Board’s determination
of the fair value of the Company’s ordinary shares considered various objective and subjective factors it believed to be
relevant, along with input from an independent third-party valuation firm, which used methodologies, approaches and assumptions
consistent with the American Institute of Certified Public Accountants Accounting and Valuation Guide, Valuation of Privately-Held-Company
Equity Securities Issued as Compensation (the “AICPA Valuation Guide”), to determine the fair value
of its ordinary shares at each option grant date. These factors included:
· the progress of the Company’s research and development programs;
· achievement of milestones, including entry by the Company into collaboration and licensing agreements;
· the Company’s need for future financing to fund operations;
· the likelihood of achieving a discrete liquidity event such as a sale of the Company or an IPO
in light of prevailing market conditions;
· external market conditions affecting the biotechnology industry; and
· the lack of an active public market for the Company’s ordinary shares.
Each of the enterprise
value allocation methods are described as follows:
· Black & Scholes Model. The Black & Scholes Model uses a “continuous-time framework”
to trace the evolution of an option’s key underlying variables by assuming a lognormal distribution of price returns.
· PWERM. Using this method, the value of ordinary shares is estimated based upon the analysis
of future values of a company, assuming various outcomes. The ordinary share value is based on the probability-weighted present
value of expected future investment returns considering each of the possible outcomes available as well as the rights of the ordinary
shares.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY Sol-Gel Technologies Ltd.
September 1, 2017
Page 4
· Hybrid
method. The hybrid method is a PWERM where the equity value in one of the scenarios
is calculated using the Black & Scholes Model. In the hybrid method used by the Company
for valuations as from July 13, 2017, two types of future-event scenarios were considered:
an IPO in October 2017 and a stay-private scenario. The relative probability of
each type of future-event scenario for the Company was determined by management based
on an analysis of market conditions at the time, including the expected IPO valuation
of the company.
Grant Date Fair Value Determinations
The Company obtained
independent third-party valuations of its ordinary shares from April 2016 to August 2017, including as of February 2017 and July-August
2017 (collectively, the “Third-Party Valuation”). The February 2017 valuation was performed on a retrospective
basis as of August 22, 2017. The July 2017 and August 2017 valuations were performed on a retrospective basis as of August 31,
2017. The Third-Party Valuation was one of the factors considered by the Company to assist in its determination of the fair value
of its ordinary shares. The Third-Party Valuation as of July 2017 and August 2017 was performed using the hybrid method described
above. For the two future-event scenarios discussed above, the Company estimated cumulative probabilities of 70% and 30% for an
IPO scenario and the stay-private scenario, respectively, based on the Company’s assessment of its development pipeline,
market conditions and its progress in undertaking an IPO.
Other
considerations that factored into the Third-Party Valuation included: the estimated volatility, the expected term of the
options, the risk-free interest rate, and the Company’s financial condition and structure at the time of the sale.
The Company believes
that the potential liquidity events used in the Third-Party Valuation and the probability weighting of each methodology and liquidity
event was appropriate at the time of analysis in light of the Company’s stage of development, its operating results, its
prospects for an IPO in the near term, general conditions in the capital markets (including with respect to IPOs) and the relative
likelihood of achieving an IPO in light of prevailing market conditions as compared to a sale of the Company. The timing of these
future liquidity event scenarios was determined based primarily on input from the Board.
The Third-Party Valuation
estimated that the valuation of the Company’s ordinary shares was $36.84 per share as of February 2017 and $43.87 per share
as of July and August 2017. Based on that result, as well as consideration of other qualitative factors, the Company concluded
that, for accounting purposes, the fair value of the ordinary shares underlying share options it granted on February 12, 2017
was $36.84 per share. With respect to the July 2017 and August 2017 share option grants, the Company concluded that the fair value
of the ordinary shares underlying such share options was $43.87 per share. The Company used the assessed fair value of
ordinary shares to determine the share-based compensation expense related to the February 12, 2017 share option grants and the
July 2017 and August 2017 share option grants.
COMPARISON OF MOST RECENT ESTIMATED
VALUATION AND PRELIMINARY ASSUMED IPO PRICE
As noted above, the
Preliminary IPO Price Range is $[*] to $[*] per share, with a Preliminary Assumed IPO Price of approximately $[*] per share. The
Company notes that, as is typical in the IPO process, the estimated price range for the proposed IPO was not derived using a formal
determination of fair value, but was determined based on negotiation between it and the Underwriters. The factors that were considered
in setting the Preliminary IPO Price Range included the following:
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY Sol-Gel Technologies Ltd.
September 1, 2017
Page 5
· an analysis of the typical valuation ranges seen in recent IPOs for companies in the biopharmaceutical
industry during the past year;
· the general condition of the U.S. securities markets and the recent market prices of, and the demand
for, publicly-traded stock of generally comparable companies;
· the recent performance of U.S. initial public offerings of generally comparable companies;
· estimates of business potential and earnings prospects for the Company and the industry in which
it operates;
· the Company’s financial position;
· an assumption that there would be a receptive U.S. public trading market for a dermatology company
like the Company; and
· an assumption that there would be sufficient demand for the Company’s ordinary shares to
support an offering of the size contemplated by the proposed IPO.
The Company believes
that the difference between the fair value of its ordinary shares as of February 12, 2017 of $36.84 per share and the Preliminary
Assumed IPO Price is the result of the factors above and the following:
· Positive
clinical results: On July 20, 2017, the Company reported positive top-line results
from a Phase II clinical trial of its lead product candidate TWIN, a novel, once-daily,
non-antibiotic topical cream being developed for the treatment of acne vulgaris.
· Increased probability of an IPO: The Preliminary IPO Price Range is based only upon a scenario
in which the Company completes the IPO and is not probability weighted, in contrast to the Company’s prior valuations of
ordinary shares, which considered other potential exit scenarios, which would have resulted in a lower value of its ordinary shares
than an IPO.
· Increased value and liquidity of the ordinary shares as a public company: The anticipated
price range for the IPO necessarily assumes that the IPO has occurred and that a public market for the Company’s ordinary
shares has been created, and, therefore, excludes any discount for lack of marketability of the Company’s ordinary shares.
As described above, a discount for lack of marketability was applied in the Third-Party Valuation.
· Conversion
of the Company’s outstanding promissory note between the Company and its controlling
shareholder at IPO: The Company has an outstanding promissory note with its controlling
shareholder with an aggregate principal amount of approximately $65.3 million. Immediately
prior to the closing of an IPO, the promissory note will convert into ordinary
shares, at a conversion rate determined by the initial public offering price per ordinary
share, thus eliminating the outstanding debt obligation and priority as comp
2017-08-29 - CORRESP - Sol-Gel Technologies Ltd.
CORRESP
1
filename1.htm
53rd at Third
885 Third Avenue
New York, New York 10022-4834
Tel: +1.212.906.1200 Fax: +1.212.751.4864
www.lw.com
August 29, 2017
FIRM /
AFFILIATE OFFICES
Barcelona
Moscow
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Washington, D.C.
Milan
VIA EDGAR AND HAND DELIVERY
Ms. Suzanne Hayes
Assistant Director
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E
Washington, D.C. 20549
Re: Sol-Gel Technologies Ltd.
Registration Statement on Form
F-1
(CIK No. 0001684693)
Dear Ms. Hayes:
On behalf of Sol-Gel Technologies Ltd. (the
“Company”), we are transmitting this letter in response to comments received from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) by letter dated August 28, 2017 with respect
to the Company’s draft Registration Statement on Form F-1 (the “Confidential Registration Statement”).
This letter is being submitted together with a copy of the Registration Statement on Form F-1, which was filed on EDGAR on August
29, 2017 and revises the Confidential Registration Statement to address the Staff’s comments (the “Registration
Statement”). The bold and numbered paragraphs below correspond to the numbered paragraphs in the Staff’s letter
and are followed by the Company’s responses. For the Staff’s convenience, we are also sending, by courier, copies of
this letter and marked copies of the Registration Statement that reflect changes made to the Confidential Registration Statement.
August
29, 2017
Page
2
Prospectus Summary
Overview, Page 1
1. We note your reference in the third paragraph on page 1 to a “shorter regulatory approval process for our product
candidate compared with drug delivery systems based on novel excipients.” As currently drafted,
the disclosure implies that your product candidates will be approved and the regulatory process will be shorter than it is for
other product candidates. While it is appropriate for you to say that you will be relying upon prior findings during your development
program and the process may be more efficient than if you conducted similar trials, please revise your disclosure to remove any
implications that your product candidates will be approved, are more likely to receive FDA approval or will be approved quickly.
If you continue to believe that the regulatory process is shorter than it is for other product candidates, please explain how you
expect your use of silica results in fewer trials, shorter trials or other ways of shortening the regulatory process timeframe.
Please also make similar revisions throughout your prospectus, including in your Business section, as necessary.
Response: The Company acknowledges the Staff’s
comment and has revised the disclosure in the Registration Statement on pages 1, 66 and 80.
Risk Factors
Page 21
2. We note the risk factor on page 21 that 17.6% of patients enrolled in your TWIN Phase II clinical trial did not complete
the study. Please revise the Summary and Business section, to clarify that 128 patients did not complete the study.
Response: The Company acknowledges the Staff’s
comment and has revised the disclosure in the Registration Statement on pages 2, 22, 80, 85, 88 and 92.
Prospectus Summary
Overview, Page 2
3. Efficacy determinations are solely within the FDA’s authority. As your product candidates have not received FDA approval,
it is premature to state that they are safe or effective. To the extent that your clinical trials support the statements, you may
state that your product candidate trials met the primary and secondary endpoints. You may present p values with an explanation
of the meaning of these values in the Business section. Please revise your statement “TWIN also exhibited favorable efficacy
results compared to its individual active components” on page 2 and all other statements indicating that your products are
effective or more effective than other treatments.
Response: The Company acknowledges the Staff’s
comment and has revised the disclosure in the Registration Statement on pages 2 and 81.
August
29, 2017
Page
3
Prospectus Summary
Overview, Page 2
4. We note your statement on page 2 that you believe “TWIN represents a differentiated product when compared with currently
approved topical acne treatments and, if approved, has the potential to become a preferred treatment for acne.” Additionally,
we note your disclosure on page 25 indicating that your branded product candidates were not, and will not be subject to head-to-head
clinical trials with drugs considered the applicable standard of care. Please revise the referenced statement comparing TWIN to
currently approved products and all other similar statements contained on page 86 and elsewhere.
Response: The Company acknowledges the Staff’s
comment and has revised the disclosure in the Registration Statement on pages 2, 81, 82, 89 and 92.
Prospectus Summary
Overview, Page 3
5. We note your reference to your generic product candidate agreement you are developing with Douglas Pharmaceuticals. To the
extent that the generic product candidate is material to your operations, please identify the drug and the indication. If is not
material to your operations, please remove the references from the summary.
Response: The Company acknowledges the Staff’s
comment and has revised the disclosure in the Registration Statement on pages 3 and 4.
If you have any questions regarding the
foregoing responses or the enclosed Registration Statement, please do not hesitate to contact me by telephone at (212) 906-2916.
Very truly yours,
/s/ Nathan Ajiashvili
Nathan Ajiashvili
of LATHAM & WATKINS LLP
cc: Alon Seri-Levy, Chief Executive Officer, Sol-Gel Technologies Ltd.
Joshua Kiernan, Latham & Watkins LLP
Gene Kleinhendler, Gross, Kleinhendler, Hodak, Halevy,
Greenberg & Co.
2017-08-28 - UPLOAD - Sol-Gel Technologies Ltd.
Mail Stop 4546 August 28, 2017 Alon Seri -Levy Chief Executive Officer Sol-Gel Technologies Ltd. 7 Golda Meir St., Weizmann Science Park Ness Ziona, 7403648, Israel Re: Sol-Gel Technologies Ltd. Amendment No. 3 to Draft Registration Statement on Form F-1 Submitted A ugust 11 , 2017 CIK No. 0001684693 Dear Mr. Seri -Levy : 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 comme nts 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. Prospectus Summary Overview, Page 1 1. We note your reference in the third paragraph on page 1 to a “shorter regulatory approval process for o ur product candidate compared with drug delivery systems based on novel excipients.” As currently drafted, the disclosure impl ies that your product candidates will be approved and the regulatory process will be shorter than it is for other product candida tes. While it is appropriate for you to say that you will be relying upon prior findings during your development program and the process may be more efficient than if you conducted similar trials, please revise your disclosure to remove any implications Alon Seri -Levy Sol-Gel Technologies Ltd. August 28, 2017 Page 2 that your product candidates will be approved, are more likely to receive FDA approval or will be approved quickly. If you continue to believe that the regulatory process is shorter than it is for other product candidates, please explain how you expect you r use of silica results in fewer trials, shorter trials or other ways of shortening the regulatory process timeframe. Please also make similar revisions throughout your prospectus, including in your Business section, as necessary. 2. We note the risk facto r on page 21 that 17.6 % of patients enrolled in your TWIN Phase II clinical trial did not complete the study. Please revise the Summary and Business section, to clarify that 128 patients did not complete the study. 3. Efficacy determinations are solely with in the FDA’s authority. As your product candidates have not received FDA approval, it is premature to state that they are safe or effective. To the extent that your clinical trials support the statements, you may state that your product candidate trials met the primary and secondary endpoints. You may present p values with an explanation of the meaning of these values in the Business section. Please revise your statement “TWIN also exhibited favorable efficacy results compared to its individual active co mponents” on page 2 and all other statements indicating that your products are effective or more effective than other treatments . 4. We note your statement on page 2 that you believe “ TWIN represents a differentiated product when compared with currently approved topical acne treatments and, if approved, has the potential to become a preferred treatment for acne.” Additionally, we note your disclosure on page 25 indicating that your branded product candidates were not, and will not be subject to head -to-head clinical trials with drugs considered the applicable standard of care. Please revise the referenced statement comparing TWIN to currently approved products and all other similar statements contained on page 86 and elsewhere . 5. We note your reference to your generic product candidate agreement you are developing with Douglas Pharmaceuticals. To the extent that the generic product candidate is material to your operations, please identify the drug and the indication. If is not material to your operatio ns, please remove the references from the summary. Alon Seri -Levy Sol-Gel Technologies Ltd. August 28, 2017 Page 3 You may contact Ibolya Ignat at (202) 551 -3636 or Angela Connell at (202) 551 -3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at (202) 551 -2544 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare & Insurance cc: Nathan Ajiashvili , Esq. Latham & Watkins LLP
2017-05-01 - UPLOAD - Sol-Gel Technologies Ltd.
Mail Stop 4546 April 28, 2017 Alon Seri -Levy Chief Executive Officer Sol-Gel Technologies Ltd. 7 Golda Meir St., Weizmann Science Park Ness Ziona, 7403648, Israel Re: Sol-Gel Technologies Ltd. Amendment No. 1 to Draft Registration Statement on Form F-1 Submitted April 3, 2017 CIK No. 0001684693 Dear Mr. Seri -Levy : 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 app ly 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. Prospectus Summary, page 1 1. Please delete your statement that you believe VERED has the potential to be more effective than currently market ed rosacea drugs. The statement is speculative and efficacy is a determination made by the FDA. 2. We note your reference to Product Z and your statement that you have not identified Product Z for competitive reasons. Please note, it is not appropriate to reference the development of this product without providing sufficient information for investors to assess its significance. To the extent Product Z is material to your operations, please Alon Seri -Levy Sol-Gel Technologies Ltd. April 28, 2017 Page 2 identify the brand -name drug and the indication. If Product Z i s not material to your operations, please remove the references from the summary. 3. We note your response to comment 17. Please expand your discussion to explain that an improved “treatment landscape” may not result in significant improvements in results, if any. Risks Related to Our Intellectual Property, page 38 4. We note that in October 2011, Medicis Pharmaceutical Corporation entered into an assignment agreement with you to which Medicis assigned to you its entire interest in one of the patents upon whi ch you rely for your product candidate TWIN. Please file your agreement as an exhibit or provide an analysis supporting your determination that you are not required to file it pursuant to Item 601(b)(10) of Regulation S -K. Management’s Discussion and An alysis of Financial Condition and Results of Operations Significant Accounting Policies and Estimates Stock -Based Compensation, page 74 5. In providing the information requested in prior comment 15, please quantify the enterprise value established at each va luation date and include a discussion of the reasons for the changes in your underlying enterprise value at each valuation date and as compared to your offering price. Branded Product Candidates, page 80 6. We note your response to comment 18 that quanti tative information on the royalty obligations is disclosed on pages 105 -106 of the registration statement, currently 3% to 5% on the sales of products or services. However, on page 72 you state that “[u]nder the terms of the funding arrangements with NATI , royalties of 3.5% to 25% are payable on the sale of products.” Please reconcile your disclosure. Intellectual Property, page 95 7. We note your response to prior comment 23. Please clarify how your patent portfolio is structured in terms of which patents are proprietary and which patents you license and identify whether the material patents you referenced relate to the Yissum patents . Alon Seri -Levy Sol-Gel Technologies Ltd. April 28, 2017 Page 3 Report of Independent Registered Public Accounting Firm , Page F -2 8. The report of your independent registered public accounting firm is not dated and does not include a conformed signature . Please have your independent registered public accounting firm revise their report to comply with the requirements of Rule 2.02 of Regulation S -X. Financial Statements Notes to Financial Statements Note 4 – Commitments, page F -12 9. On page F -14 you disclose the terms of a development, manufacturing and commercialization agreement entered into with a third party in April 2015, as amended on October 26, 2015. With respect to the third party’s obligation to reimburse you for 40% of the out -of-pocket clinical trial expenses a nd the resulting long -term receivable recognized, please disclose the settlement terms of any amounts due to you and how collectability of the receivable is evaluated. Exhibits, page II -3 10. We note your response to comment 23. Please file your agreement with Yissum pursuant to Item 601(b)(10)(ii)(B) or provide us with an analysis supporting your determination that you are not substantially dependent on the agreement. You may contact Ibolya Ignat at (202) 551 -3636 or Angela Connell at (202) 551 -3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at (202) 551 -2544 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare an d Insurance cc: Nathan Ajiashvili , Esq. Latham & Watkins LLP
2016-10-27 - UPLOAD - Sol-Gel Technologies Ltd.
Mail Stop 4546 October 26, 2016 Alon Seri -Levy Chief Executive Officer Sol-Gel Technologies Ltd. 7 Golda Meir St., Weizmann Science Park Ness Ziona, 7403648, Israel Re: Sol-Gel Technologies Ltd. Draft Registration Statement on Form F -1 Submitted September 28, 2016 CIK No. 0001684693 Dear Mr. Seri -Levy : We have reviewed your draft registration statement and have the following comments. In some of our comments, we m ay 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. Prospectus Summary Overview of Our Product Candidates, page 2 1. We note that the prospectus states that the only generic product candidate you discuss is ivermectin cream, 1%. According to your description of the current stage of development, this appears to be the product c andidate identifies as Product Y on your Website. Please tell us about the product identified as Product X on your we bsite and explain why you have not provided any disclosure about it. 2. Safety and efficac y determinations are solely within the FDA ’s authority . As your product candi dates have not received FDA approval, it is premature to state that they are Alon Seri -Levy Sol-Gel Technologies Ltd. October 26, 2016 Page 2 safe or effective. To the extent that your clinical trials support the statements, you may state that your product candidates have shown to be well tolerated and demonstrated statistically significant improvements. Please revise your statement “VERED demonstrated statistically significant efficacy compared to the control vehicle group” and all other statements indicating that your products are safe and effective. 3. We note your statement in the fourth paragraph that you believe E-06 “will improve patient comfort and compliance as compared to current ly approved products.” Additionally , we note your disclosure on page 25 indicating that your branded product candi dates were not, and will not be subject to head -to-head clinical trials with drugs considered the applicable standard of care. Please revise the refer enced statement comparing E -06 and all your other branded products to currently approved products. Our Strengths, page 3 4. We note your reference in the second paragraph on page 4 to a “[f]aster NDA ap proval process compared to new chemical entities .” As currently drafted, th e disclosure implies that you r product candidates will be approved and the process will be easier or faster than the approval process for other chemical entities. Although you may rely upon the FDA’s previous findings of safety and effic acy of an approved product, your product is still distinct from prior products approved by the FDA. While it is appropriate for you to say that you will be relying upon prior findings during your development program and the process may be more e fficient than if you conducted similar trials , please revise your disclosure to remove any implications that your product candidates will be appro ved, are more l ikely to receive FDA approval or will be approved quickly . Please also make similar revisions throughout your prospectus, including in your Business section, as necessary. Implications of B eing an Emerging Growth Company and a Foreign Private Issuer, page 6 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, pr esent to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. 6. We note your statement that you may delay the adoption of certain accounting standards until those standards would otherwise apply to priv ate companies . This statement is not consistent with your statement on page 74 which indicates that you have elected to utilize this exemption and will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. Please revise y our disclosure to provide consistent disclosure about your intent to rely on the extended transition period. Alon Seri -Levy Sol-Gel Technologies Ltd. October 26, 2016 Page 3 Risk Factors The Israeli government grants that we have received …, page 42 ” 7. Please identify your product candidates that are subject to conditions an d restrictions related to Israeli government grants. As a foreign private issuer w hose shares are listed on the NASDAQ…, page 49 8. We note your disclosure on page 55 and throughout the prospectus that you intend to follow home country corporate governance practices. Please revise to provide a concise summary o f all material differences between corporate governance practices in Israel and required by NASDAQ for domestic companies . Market and Industry Data, page 55 9. You state “[w]e have not independently verified any of the data from third -party sources nor have we ascertained the underlying economic assumptions relied upon therein .” To eliminate any inference that you are not liable for all of the information in your registration statement, please delete this statement or include a statement s pecifically acknowledging your liability for information that appears in your registration statement that was obtained from third party sources. Use of Proceeds, page 56 10. Please revise the discussion to identify the stage of development you expect to achieve with the proceeds of the offering. To the extent you expect to begin particular stage of development but do not expect to complete it, please indicate that you will need to raise additional funding to complete that stage of development. 11. We note your statement that “[a]s of the date of this prospectus, we cannot pred ict with certainty any or all the particular uses for the net proceeds…[a]s a result, our management will have broad discretion in the application of the net proceeds….” Please revise to clarify whether any of the proceeds from the offering may be used to repay indebtedness , which totaled $19.7 million . Please provide the disclosure required by 3.C of Form 20 -F. Management’s Discussion and Anal ysis of Financial Condition and Results of Operations Collaboration Agreements , page 6 4 12. We note that ivermectin cream, 1% is being developed in collaboration with a major generic drug company. Identify you r collaborative partner throughout your filing . File the agreement as an exhibit or provide an analysis suppor ting your determination that you are not required to file it pursuant to Item 601(b)(10) of Regulation S -K. Alon Seri -Levy Sol-Gel Technologies Ltd. October 26, 2016 Page 4 13. Please expand the discussion of your collaborative agreement related to ivermectin cream, 1% to disclose termination provisions and each party ’s obligations under t he agreement, including cost sharing provisions and expenses related to potential patent infringement litigation. 14. Please file your agreement with Perrigo Israel as an exhibit or provide a n analysis supporting yo ur det ermination that you are not required to file it pursuant to Item 601(b)(1) of Regulation S -K. Furthe rmore, please also d escribe all termination provisions and disclose when the obligation to pay royalties terminates. Significant Accounting Policies and Estimates Stock -Based Compensation, page 71 15. Once you have an estimated offering price or range, please explain to us how you deter mined the fair value of the common stock underlying your equity issuances and the reasons for any differences between the recent valuations of your common stock leading up to the IPO and the estimated offering price. This information will help facilitate o ur review of your accounting for equity issuances including stock compensation and beneficial conversion features. 16. As a related matter, we note that you performed a retrospective valuation in April 2016 in which you determined your enterprise value and a llocated it among the different elements of your share capital using an option pricing model. Please tell us how the August 4, 2014 securities purchase agreement with Arkin Dermatology in exchange for a cash payment of approximately $10.5 million in addit ion to an earn out payment of up to $17.0 million based on the achievement of certain development and revenue -related milestones was considered in the calculation of your enterprise value. Business , page 75 17. We note your statement on page 1 indicating that you believe your microencapsulation delivery system enabl es you to develop topical dermatological drug products “with potentially significant advantages over existing marketed drug products” and your similar discussion under “[p]roprietary microencapsulation drug delivery system” on page 4. Please revise this discussion to provide the basis for your belief. Alternatively, remove statement s indicating that your techn ology enables you to develop products with advantages to existing products. Alon Seri -Levy Sol-Gel Technologies Ltd. October 26, 2016 Page 5 Branded Product Candidates, page 80 18. Please identify the product candida tes that were partially funde d based on OCE grants and quantify your royalty obligations with respect to these product candidates. Additionally , revise the description of ive rmectin cream, 1%. 19. To the extent there were any serious adverse effects related to treatment with any of your branded or generic product candidates, please revise your disclos ure to describe the effects. 20. We note on page 81 that during the Phase II trial for VERED the first co -primary endpoint was the proportion of patients with a two grade reduction in investigator global assessment, or IGA , scored clear or almost clear. Please describe any guidance that was provided in determining what consti tuted “clear ” or “almo st clear. ” Our Topical Drug Delivery Technology Platform, page 90 21. We note your statement on page 91 that “[t]he FDA preliminarily accepted [your] suggested in -process specification and analytical procedures for the encapsulated product candidates.” Please summarize the nature and extend of your communications, if an y, with the FDA regarding your product candidates and clinical trials. Intellectual Property, page 91 22. Please expand your disclosure to indicate the products related to your current patents and patent applications . Additionally , clarify the type of patent protection such as composition of matter, use of process; provide patent expiration dates or expected expiration dates for patent applications; and iden tify the applicable jurisdictions for existing patents and pending patent applications . 23. We note your disclosure on page F-13 that you licensed certain commercialization rights with respect to Yissum patents. Please tell us whether any of your product candidates are dependent on technology you licensed from Yissum. Exhibits, page II -3 24. Please file your employment or services agreements with your executive officers and the 2014, 2015 and 2016 loan agreements with Arkin Dermatology as exhibits . 25. Please tell us the basis for your determination not to file your lease agreement for your facility in Weizmann Science Park reference d on page 106. Alon Seri -Levy Sol-Gel Technologies Ltd. October 26, 2016 Page 6 Other 26. Please sub mit all outstanding exhibits as soon as prac ticable. We may have further comments upo n exa mination of these exhibits. 27. Please provide us proofs of all graphic, 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. You may contact Ibolya Ignat at (202) 551 -3636 or Angela Connell at (202) 551 -3426 if you have questions regarding comments on the fi nancial statements and related matters. Please contact Jeffrey Gabor at (202) 551 -2544 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Suzan ne Hayes Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Nathan Ajiashvili , Esq. Latham & Watkins LLP