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Scinai Immunotherapeutics Ltd.
Response Received
1 company response(s)
Medium - date proximity
↓
Scinai Immunotherapeutics Ltd.
Response Received
1 company response(s)
High - file number match
↓
Scinai Immunotherapeutics Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-02-02
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
↓
Company responded
2024-02-09
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2023-12-26
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-08-22
Scinai Immunotherapeutics Ltd.
Summary
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↓
Company responded
2023-08-23
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2022-10-05
Scinai Immunotherapeutics Ltd.
Summary
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↓
Company responded
2022-12-14
Scinai Immunotherapeutics Ltd.
Summary
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Company responded
2022-12-14
Scinai Immunotherapeutics Ltd.
Summary
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Scinai Immunotherapeutics Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-08-05
Scinai Immunotherapeutics Ltd.
Summary
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Company responded
2020-08-06
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-04-08
Scinai Immunotherapeutics Ltd.
Summary
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Company responded
2019-06-05
Scinai Immunotherapeutics Ltd.
Summary
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Company responded
2019-06-05
Scinai Immunotherapeutics Ltd.
Summary
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Scinai Immunotherapeutics Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-05-30
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2017-02-02
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-12-14
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-11-21
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-05-11
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-05-11
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-05-06
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-05-06
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-05-01
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-05-01
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-04-28
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-04-28
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-04-24
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-04-24
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-04-06
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-01-12
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Scinai Immunotherapeutics Ltd.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2014-12-11
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
↓
Company responded
2014-12-29
Scinai Immunotherapeutics Ltd.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2025-09-29 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | 333-290437 | Read Filing View |
| 2025-03-11 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2025-03-11 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | 333-285547 | Read Filing View |
| 2024-02-09 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2024-02-02 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | 333-276767 | Read Filing View |
| 2023-12-26 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-08-23 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-08-22 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2022-12-14 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2022-12-14 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2022-10-05 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2020-08-06 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2020-08-05 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2019-06-05 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2019-06-05 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2019-05-30 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2019-04-08 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2017-02-02 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2016-12-14 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2016-11-21 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-11 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-11 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-06 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-06 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-01 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-01 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-04-28 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-04-28 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-04-24 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-04-24 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-04-06 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-01-12 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2014-12-29 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2014-12-11 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | 333-290437 | Read Filing View |
| 2025-03-11 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | 333-285547 | Read Filing View |
| 2024-02-02 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | 333-276767 | Read Filing View |
| 2023-08-22 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2022-10-05 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2020-08-05 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2019-05-30 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2019-04-08 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-01-12 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2014-12-11 | SEC Comment Letter | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2025-03-11 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2024-02-09 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-12-26 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-08-23 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2022-12-14 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2022-12-14 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2020-08-06 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2019-06-05 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2019-06-05 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2017-02-02 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2016-12-14 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2016-11-21 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-11 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-11 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-06 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-06 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-01 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-05-01 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-04-28 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-04-28 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-04-24 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-04-24 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2015-04-06 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
| 2014-12-29 | Company Response | Scinai Immunotherapeutics Ltd. | Israel | N/A | Read Filing View |
2025-09-29 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP 1 filename1.htm Scinai Immunotherapeutics Ltd. Jerusalem BioPark, 2 nd Floor Hadassah Ein Kerem Campus Jerusalem, Israel September 29, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Doris Stacey Gama Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS Scinai Immunotherapeutics Ltd. (CIK No. 0001611747) Registration Statement on Form F-1 (File No. 333- 290437) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Scinai Immunotherapeutics Ltd. (the "Company") hereby requests acceleration of the effective date of its Registration Statement on Form F-1 (File No. 333- 290437) so that it will be declared effective at 3:00 p.m., Eastern Standard Time, on September 30, 2025, or as soon thereafter as is practicable. Should you have any questions regarding this letter, please do not hesitate to contact Perry Wildes, Adv., at +972 (3) 607-4444 or perry.wildes@goldfarb.com, of Goldfarb Gross Seligman & Co., counsel to the Company. Sincerely, Scinai Immunotherapeutics Ltd. By: /s/ Amir Reichman Amir Reichman Chief Executive Officer
2025-09-29 - UPLOAD - Scinai Immunotherapeutics Ltd. File: 333-290437
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 29, 2025 Amir Reichman Chief Executive Officer Scinai Immunotherapeutics Ltd. Jerusalem BioPark, 2nd Floor Hadassah Ein Kerem Campus Jerusalem, Israel Re: Scinai Immunotherapeutics Ltd. Registration Statement on Form F-1 Filed September 22, 2025 File No. 333-290437 Dear Amir Reichman: 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 Doris Stacey Gama at 202-551-3188 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Perry Wildes, Esq. </TEXT> </DOCUMENT>
2025-03-11 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP 1 filename1.htm Scinai Immunotherapeutics Ltd. Jerusalem BioPark, 2 nd Floor Hadassah Ein Kerem Campus Jerusalem, Israel March 11, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tim Buchmiller Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS Scinai Immunotherapeutics Ltd. (CIK No. 0001611747) Registration Statement on Form F-1 (File No. 333-285547) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Scinai Immunotherapeutics Ltd. (the "Company") hereby requests acceleration of the effective date of its Registration Statement on Form F-1 (File No. 333-285547) so that it will be declared effective at 5:00 p.m., Eastern Standard Time, on March 12, 2025, or as soon thereafter as is practicable. Should you have any questions regarding this letter, please do not hesitate to contact Perry Wildes, Adv., at +972 (3) 607-4444 or perry.wildes@goldfarb.com, of Goldfarb Gross Seligman & Co., counsel to the Company. Sincerely, Scinai Immunotherapeutics Ltd. By: /s/ Amir Reichman Amir Reichman Chief Executive Officer
2025-03-11 - UPLOAD - Scinai Immunotherapeutics Ltd. File: 333-285547
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 11, 2025 Amir Reichman Chief Executive Officer Scinai Immunotherapeutics Ltd. Jerusalem BioPark, 2nd Floor Hadassah Ein Kerem Campus Jerusalem, Israel Re: Scinai Immunotherapeutics Ltd. Registration Statement on Form F-1 Filed March 4, 2025 File No. 333-285547 Dear Amir Reichman: 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: Perry Wildes, Esq. </TEXT> </DOCUMENT>
2024-02-09 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP
1
filename1.htm
Scinai
Immunotherapeutics Ltd.
Jerusalem
BioPark, 2nd Floor
Hadassah
Ein Kerem Campus
Jerusalem,
Israel
February
9, 2024
Via
EDGAR Transmission
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Scinai Immunotherapeutics Ltd.
Registration Statement on Form F-3
Filed January 30, 2024
Registration No. 333-276767
Ladies
and Gentlemen:
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 February
13, 2024 at 9:15 a.m. Eastern Time or as soon thereafter as practicable, or at such later time as Scinai Immunotherapeutics Ltd. (the
“Company”) or its counsel may request via telephone call to the staff.
Please
contact Steven A. Lipstein of Lucosky Brookman LLP, counsel to the Company, at (732) 395-4416, or in his absence, Perry Wildes of Goldfarb
Gross Seligman & Co., counsel to the Company, at + 972-3-607-4444, to provide notice of effectiveness, or if you have any other questions
or concerns regarding this matter.
Sincerely yours,
Scinai Immunotherapeutics Ltd.
By:
/s/ Amir
Reichman
Amir Reichman
Chief Executive Officer
cc:
Steven A. Lipstein, Lucosky Brookman LLP
Perry Wildes, Goldfarb Gross Seligman & Co.
2024-02-02 - UPLOAD - Scinai Immunotherapeutics Ltd. File: 333-276767
United States securities and exchange commission logo
February 2, 2024
Amir Reichman
Chief Executive Officer
Scinai Immunotherapeutics Ltd.
Jerusalem BioPark, 2nd Floor
Kiryat Hadassah, Building 1, JBP
Jerusalem, Israel 9112001
Re:Scinai Immunotherapeutics Ltd.
Registration Statement on Form F-3
Filed January 30, 2024
File No. 333-276767
Dear Amir Reichman:
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 Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Steven A. Lipstein
2023-12-26 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP
1
filename1.htm
Scinai Immunotherapeutics Ltd.
Jerusalem BioPark, 2nd Floor
Hadassah Ein Kerem Campus
Jerusalem, Israel
December 26, 2023
Via EDGAR Transmission
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Scinai Immunotherapeutics Ltd.
Registration Statement on Form F-1
Filed October 30, 2023, as amended
Registration No. 333-275217
Ladies and Gentlemen:
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 December 26, 2023 at 4:30 p.m. Eastern Time or as soon
thereafter as practicable, or at such later time as Scinai Immunotherapeutics Ltd. (the “Company”) or its counsel may
request via telephone call to the staff.
Please contact Steven A. Lipstein of Lucosky Brookman
LLP, counsel to the Company, at (732) 395-4416, or in his absence, Perry Wildes of Goldfarb Gross Seligman & Co., counsel to the Company,
at + 972-3-607-4444, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely yours,
Scinai Immunotherapeutics Ltd.
By:
/s/ Amir Reichman
Amir Reichman
Chief Executive Officer
cc:
Steven A. Lipstein, Lucosky Brookman LLP
Perry Wildes, Goldfarb Gross Seligman & Co.
2023-08-23 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP
1
filename1.htm
BiondVax
Pharmaceuticals Ltd.
Jerusalem BioPark, 2nd Floor
Kiryat Hadassah, Building 1, JBP
Jerusalem, Israel 9112001
August 23, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Ms. Cindy Polynice
Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS
BiondVax Pharmaceuticals Ltd. (CIK No. 0001611747)
Registration Statement on Form F-3 (File No. 333-274078)
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of
1933, as amended, BiondVax Pharmaceuticals Ltd. (the “Company”) hereby requests acceleration of the effective date of its
Registration Statement on Form F-3 (File No. 333-274078) so that it will be declared effective at 10:00 a.m., Eastern Standard Time, on
August 25, 2023, or as soon thereafter as is practicable.
Should you have any questions regarding this letter,
please do not hesitate to contact Perry Wildes, Adv., at +972 (3) 607-4444 or perry@gkh-law.com, of Goldfarb Gross Seligman & Co.,
counsel to the Company.
Sincerely,
BIONDVAX PHARMACEUTICALS LTD.
By:
/s/ Amir Reichman
Amir Reichman
Chief Executive Officer
2023-08-22 - UPLOAD - Scinai Immunotherapeutics Ltd.
United States securities and exchange commission logo
August 22, 2023
Amir Reichman
Chief Executive Officer
BiondVax Pharmaceuticals Ltd.
Jerusalem BioPark, 2nd Floor
Kiryat Hadassah, Building 1, JBP
Jerusalem, Israel 9112001
Re:BiondVax Pharmaceuticals Ltd.
Registration Statement on Form F-3
Filed on August 18, 2022
File No. 333-274078
Dear Amir Reichman:
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 Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Perry Wildes, Esq.
2022-12-14 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP
1
filename1.htm
BiondVax Pharmaceuticals Ltd.
Jerusalem BioPark, 2nd Floor
Hadassah Ein Kerem Campus
Jerusalem, Israel
December 14, 2022
Via EDGAR Transmission
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
BiondVax Pharmaceuticals Ltd.
Registration Statement on Form F-1
Filed September 29, 2022, as amended
Registration No. 333-267648
Ladies and Gentlemen:
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 December 15, 2022 at 4:15 p.m. Eastern Time or as soon
thereafter as practicable, or at such later time as BiondVax Pharmaceuticals Ltd. (the “Company”) or its counsel may
request via telephone call to the staff.
Please contact Steven A. Lipstein of Lucosky Brookman
LLP, counsel to the Company, at (732) 395-4416, or in his absence, Perry Wildes of Gross & Co., counsel to the Company, at + 972-545651-137,
to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely yours,
BiondVax Pharmaceuticals Ltd.
By:
/s/ Amir Reichman
Amir Reichman
Chief Executive Officer
cc:
Steven A. Lipstein, Lucosky Brookman LLP
Perry Wildes, Gross & Co.
2022-12-14 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP
1
filename1.htm
AEGIS CAPITAL CORP.
December 14, 2022
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, D.C. 20549
Re:
BiondVax Pharmaceuticals Ltd.
Registration Statement on Form F-1
File No. 333-267648
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations
under the Securities Act of 1933, as amended (the “Securities Act”), Aegis Capital Corp. hereby joins BiondVax Pharmaceuticals
Ltd. in requesting that the Securities and Exchange Commission take appropriate action to accelerate the effective date of the above-referenced
registration statement on Form F-1, as amended, so as to become effective on Thursday, December 15, at 4:15 PM Eastern Time, or as soon
thereafter as practicable.
Pursuant to Rule 460 under the Securities Act, please
be advised that we will distribute as many electronic copies of the proposed form of preliminary prospectus as it appears to be reasonable
to secure adequate distribution.
Very truly yours,
Aegis Capital Corp.
/s/ Robert J. Eide
Robert J. Eide
Chief Executive Officer
810 Seventh Avenue, 18th
floor, New York, New York 10019 (212) 813-1010/Fax (212) 813-1047
Member FINRA, SIPC
2022-10-05 - UPLOAD - Scinai Immunotherapeutics Ltd.
United States securities and exchange commission logo
October 5, 2022
Amir Reichman
Chief Executive Officer
BiondVax Pharmaceuticals Ltd.
Jerusalem BioPark, 2nd Floor
Hadassah Ein Kerem Campus
Jerusalem, Israel
Re:BiondVax Pharmaceuticals Ltd.
Registration Statement on Form F-1
Filed September 29, 2022
File No. 333-267648
Dear Amir Reichman:
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 Benjamin Richie at 202-551-7857 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Perry Wildes
2020-08-06 - CORRESP - Scinai Immunotherapeutics Ltd.
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August 6, 2020
Via EDGAR Transmission
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: BiondVax Pharmaceuticals Ltd.
Registration Statement on Form F-3
Filed July 29, 2020
Registration No. 333-240189
Ladies
and Gentlemen:
In accordance with
Rule 461 of the 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 August 10, 2020 at 4:00 p.m. Eastern Time
or as soon thereafter as practicable. Please contact our counsel, Gross, Kleinhendler, Hodak, Halevy, Greenberg, Shenhav &
Co., attention: Perry Wildes at +972-3-607-4475, or in his absence, Joshua Ravitz at +972-3-607-4480, to provide notice of effectiveness,
or if you have any other questions or concerns regarding this matter.
Very truly yours,
BiondVax Pharmaceuticals Ltd.
By:
/s/ Uri Ben Or
Uri Ben Or
Chief Financial Officer
Jerusalem
BioPark, 2nd floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone:
+972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com
2020-08-05 - UPLOAD - Scinai Immunotherapeutics Ltd.
United States securities and exchange commission logo
August 5, 2020
Ron Babecoff
Chief Executive Officer
BiondVax Pharmaceuticals Ltd.
Jerusalem BioPark, 2nd Floor
Hadassah Ein Kerem Campus
Jerusalem, Israel
Re:BiondVax Pharmaceuticals Ltd.
Registration Statement on Form F-3
Filed July 29, 2020
File No. 333-240189
Dear Dr. Babecoff:
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: Perry Wildes, Esq.
2019-06-05 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP
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File No. 333-230484
Division
of Corporation Finance
Office
of Healthcare & Insurance
Securities
and Exchange Commission
Washington,
D.C. 20549
Re: Amendment No.2 to Form F-1 Filed
May 30, 2019
Dear
Madam/Sir:
We note the receipt
by BiondVax Pharmaceuticals Ltd. (the “Company”), an Israeli company, of the comment letter (the “Comment Letter”)
dated May 30, 2019 from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
regarding the above-referenced Amendment No.2 to Form F-1. On behalf of the Company, we hereby provide the response set forth below
to the comments in the Comment Letter.
We also hereby submit
for filing an amended Registration Statement on Form F-1/A (the “Form F-1/A”), relating to the prospective rights offering
by the Company.
To assist the Staff
review, we have included the text of the Staff’s comments below in bold type.
Exhibits
1.
Please file the instrument that defines the rights of the subscription rights being registered, an opinion of counsel as to the legality of the securities being registered and consent as exhibits. See Item 601(b)(4), Item 601(b)(5), and Item 601(b)(23) of Regulation S-K.
We have filed as exhibits
10.13 and 10.14 the instruments that defines the rights of the subscription rights being registered.
Exhibit 10.13 is the
Subscription Rights Certificate. It defines the rights of the subscription rights being registered in respect of the holders of
ordinary shares of the Company that are not represented by American Depositary Shares (“ADSs”). The Company
will grant to all holders of ordinary shares (that are not represented by ADSs) as of the record date the right to purchase new
ordinary shares at a purchase price of $0.14225 per new ordinary share.
Exhibit 10.14 is the
form of the ADS Rights Agent Agreement between the Company and The Bank of New York Mellon. The ADS Rights Agreement will be executed
by the parties prior to the record date of the rights offering. The ADS Rights Agent Agreement defines the rights of the subscription
rights being registered in respect of the holders of ADSs. Each ADS represents 40 ordinary shares of the Company. The Company will
grant to existing holders of ADSs issued under the deposit agreement dated as of May 30, 2014, as amended as of May 11, 2015 among
the Company, The Bank of New York Mellon, as depositary, and all owners and holders from time to time of ADSs issued thereunder,
that are registered on the books of the depositary as of the record date, the right to purchase new ADSs at a purchase price of
$5.69 per new ADS.
We have filed as exhibits
5.1 and 23.2 an opinion of counsel as to the legality of the securities being registered and consent.
Sincerely,
Pearl Cohen
Zedek Latzer Baratz
June 5, 2019
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Division of Corporation Finance
Securities and Exchange Commission
Washington, DC 20549
Re:
BiondVax Pharmaceuticals Ltd.
Registration Statement
on Form F-1/A (Registration No. 333-230484)
Ladies and Gentlemen:
Pursuant
to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, BiondVax Pharmaceuticals Ltd. (the “Company”)
hereby requests that the effectiveness of the above-referenced Registration Statement on Form F-1/A (the “Registration Statement”)
be accelerated to, and that the Registration Statement become effective at 9:00 a.m., New York City Time on Monday June 10, 2019,
or as soon thereafter as practicable.
The
Company hereby acknowledges the following:
●
should the Commission or the staff of the Commission (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.
Very truly yours,
BIONDVAX PHARMACEUTICALS LTD.
By:
/s/ Ron Babecoff
Name:
Ron Babecoff
Title:
Chief Executive Officer and Director
2019-05-30 - UPLOAD - Scinai Immunotherapeutics Ltd.
May 30, 2019
Ron Babecoff
Chief Executive Officer and Director
BiondVax Pharmaceuticals Ltd.
Jerusalem BioPark, 2nd floor
Hadassah Ein Kerem Campus
Jerusalem, Israel
Re:BiondVax Pharmaceuticals Ltd.
Amendment No. 2 to Registration Statement on Form F-1
Filed May 30, 2019
File No. 333-230484
Dear Dr. Babecoff:
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 your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Amendment No.2 to Form F-1 Filed May 30, 2019
Exhibits
1.Please file the instrument that defines the rights of the subscription rights being registered,
an opinion of counsel as to the legality of the securities being registered and consent as
exhibits. See Item 601(b)(4), Item 601(b)(5), and Item 601(b)(23) of Regulation S-K.
FirstName LastNameRon Babecoff
Comapany NameBiondVax Pharmaceuticals Ltd.
May 30, 2019 Page 2
FirstName LastName
Ron Babecoff
BiondVax Pharmaceuticals Ltd.
May 30, 2019
Page 2
You may contact Jeffrey Gabor at 202-551-2544 or Suzanne Hayes at 202-551-3675 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Mark Hamilton, Adv.
2019-04-08 - UPLOAD - Scinai Immunotherapeutics Ltd.
April 5, 2019
Ron Babecoff
Chief Executive Officer and Director
BiondVax Pharmaceuticals Ltd.
Jerusalem BioPark, 2nd floor
Hadassah Ein Kerem Campus
Jerusalem, Israel
Re:BiondVax Pharmaceuticals Ltd.
Registration Statement on Form F-1
Filed March 25, 2019
File No. 333-230484
Dear Dr. Babecoff:
We have limited our review of your registration statement to those issues we have
addressed in our 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.
Form F-1 Filed March 25, 2019
Financial Statements, page F-1
1.Please revise to provide updated audited financial statements. Refer to Item 4(a) of Form
F-1 and Part I, Item 8.A.4 of Form 20-F.
Exhibits
2.We note that Section 7.6 of the Deposit Agreement and Section 23 of Exhibit A includes a
waiver of jury trial provision with respect to any suit, action or proceeding against the
company and/or the depositary directly or indirectly. Please revise the Deposit Agreement
FirstName LastNameRon Babecoff
Comapany NameBiondVax Pharmaceuticals Ltd.
April 5, 2019 Page 2
FirstName LastName
Ron Babecoff
BiondVax Pharmaceuticals Ltd.
April 5, 2019
Page 2
to state that, by agreeing to the provision, investors will not be deemed to have waived the
company's compliance with the federal securities laws and the rules and regulations
thereunder.
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 Jeffrey Gabor at 202-551-2544 or Suzanne Hayes at 202-551-3675 if
you have any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Tammy Zoppo, Esq.
2017-02-02 - CORRESP - Scinai Immunotherapeutics Ltd.
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February 2,
2017
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Biondvax
Pharmaceuticals Ltd.
Registration
Statement on Form F-1
File
No. 333-201283
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, BiondVax Pharmaceuticals Ltd. hereby requests acceleration of the effective
date of its Registration Statement on Form F-1 (File No. 333-201283), as amended (the “Registration Statement”),
so that it may become effective at 4:00 p.m. Eastern Daylight Time on February 2, 2017, or as soon as practical thereafter.
The
Registrant hereby authorizes Tammy Hevrony Zoppo of Pearl Cohen Zedek Latzer Baratz, Tel Aviv, to orally modify or withdraw this
request for acceleration.
The
Registrant hereby acknowledges that:
(i) should
the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare
the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration
Statement;
(ii) the
action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective,
does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration
Statement; and
(iii) the
Registrant may not assert comments of the Commission or the staff and the declaration of effectiveness of the Registration Statement
as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
We
request that we be notified of such effectiveness by a telephone call to David Aboudi, Ilan Gerzi or Tammy Hevrony Zoppo (972-3-6073777)
of Pearl Cohen Zedek Latzer Baratz. We also respectfully request that a copy of the written order from the Commission verifying
the effective time and date of such Registration Statement be sent to Pearl Cohen Zedek Latzer Baratz, Tel Aviv, attention: Tammy
Hevrony Zoppo, via facsimile at (972-3-6073778).
Best
Regards,
BiondVax
Pharmaceuticals Ltd.
/s/
Ron Babecoff
Ron
Babecoff
Chief
Executive Officer and Director
2016-12-14 - CORRESP - Scinai Immunotherapeutics Ltd.
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December
14, 2016
VIA EDGAR
United States Securities and
Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Biondvax Pharmaceuticals Ltd.
Registration Statement on Form F-3
File No. 333-214439
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933, as amended, BiondVax Pharmaceuticals Ltd. hereby requests acceleration of the effective date of its
Registration Statement on Form F-3 (File No. 333-214439), as amended (the “Registration Statement”), so
that it may become effective at 4:00 p.m. Eastern Daylight Time on December 15, 2016, or as soon as practical thereafter.
The Registrant
hereby authorizes Tammy Hevrony Zoppo of Pearl Cohen Zedek Latzer Baratz, Tel Aviv, to orally modify or withdraw this request
for acceleration.
The Registrant
hereby acknowledges that:
(i) should
the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare
the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration
Statement;
(ii) the
action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective,
does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration
Statement; and
(iii) the
Registrant may not assert comments of the Commission or the staff and the declaration of effectiveness of the Registration Statement
as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
We request that we be notified
of such effectiveness by a telephone call to David Aboudi, Ilan Gerzi or Tammy Hevrony Zoppo (972-3-6073777) of Pearl Cohen Zedek
Latzer Baratz. We also respectfully request that a copy of the written order from the Commission verifying the effective time
and date of such Registration Statement be sent to Pearl Cohen Zedek Latzer Baratz, Tel Aviv, attention: Tammy Hevrony Zoppo,
via facsimile at (972-3-6073778).
Best Regards,
BiondVax Pharmaceuticals Ltd.
/s/ Ron Babecoff
Ron Babecoff
Chief Executive Officer and Director
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November
21, 2016
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Delaying Amendment for BiondVax Pharmaceuticals Ltd., Registration Statement on Form F-3 (File No. 333-214439)
Ladies
and Gentlemen:
Pursuant
to Rule 473 under the Securities Act of 1933, as amended, BiondVax Pharmaceuticals Ltd. hereby files a delaying amendment with
respect to its Registration Statement on Form F-3 (File No. 333-214439) (the “Registration Statement”),
filed with the Securities and Exchange Commission on November 4, 2016. This filing is made solely to address language that
was inadvertently omitted from the Registration Statement.
BiondVax
Pharmaceuticals Ltd. specifically amends and incorporates into the facing page of the Registration Statement following the fee
table, the following language:
The
registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until
the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become
effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
No
fees are required in connection with this filing. If you have any questions or comments in connection with this delaying amendment,
please call David Aboudi, Ilan Gerzi or Tammy Hevrony Zoppo (972-3-6073777) of Pearl Cohen Zedek Latzer Baratz
Very
truly yours,
/s/
Ron Babecoff
Ron
Babecoff
Chief
Executive Officer and Director
BiondVax
Pharmaceuticals Ltd.
2015-05-11 - CORRESP - Scinai Immunotherapeutics Ltd.
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May 11, 2015
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-4561
Attention: Matthew Jones
Re:
Biondvax Pharmaceuticals Ltd.
Registration Statement
on Form F-1
Filed May 6, 2015
File No. 333-201283
Dear Mr. Jones:
BiondVax Pharmaceuticals
Ltd. (the “Company”) hereby requests acceleration of the effective date of the above-referenced Registration
Statement so that such Registration Statement shall become effective on May 11, 2015, at 5:00 p.m., Eastern Daylight Time, or as
soon thereafter as is practicable.
The Company hereby acknowledges that:
●
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.
Very truly yours,
/s/ Ron Babecoff
Ron Babecoff
Chief Executive Officer
2015-05-11 - CORRESP - Scinai Immunotherapeutics Ltd.
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AEGIS CAPITAL CORP.
810 Seventh Avenue
18th Floor
New York, NY 10019
May 11, 2015
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Biondvax Pharmaceuticals Ltd.
Registration Statement on Form F-1
Filed May 6, 2015
File No. 333-201283
Ladies and Gentlemen:
In accordance with
the above-referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations of the Securities and
Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as the representative
of the underwriters (the “Representative”), hereby join in the request of Biondvax Pharmaceuticals Ltd. that the effective
date of the above-referenced Registration Statement be accelerated so that it will be declared effective at 5:00 p.m., Eastern
Time, on Monday, May 11, 2015, or as soon thereafter as practicable.
Pursuant to Rule
460 under the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably
anticipated to be invited to participate in the distribution of the security, as many copies of the proposed form of preliminary
prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned,
as the representative of the underwriters, represent that the underwriters have and will comply with the requirements of Rule 15c2-8
under the Securities Exchange Act of 1934, as amended.
Very truly yours,
AEGIS CAPITAL CORP.
As Representative of the several underwriters named in
Schedule I to the Underwriting Agreement
By:
AEGIS CAPITAL CORP.
By:
/s/ Anthony Monaco
Name: Anthony M. Monaco
Title: Chief Compliance Officer
2015-05-06 - CORRESP - Scinai Immunotherapeutics Ltd.
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AEGIS CAPITAL CORP.
810 Seventh Avenue
18th Floor
New York, NY 10019
May 6, 2015
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Biondvax Pharmaceuticals Ltd.
Registration Statement on Form F-1
Filed May 6, 2015
File No. 333-201283
Ladies and Gentlemen:
In accordance with
the above-referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations of the Securities and
Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as the representative
of the underwriters (the “Representative”), hereby join in the request of Biondvax Pharmaceuticals Ltd. that the effective
date of the above-referenced Registration Statement be accelerated so that it will be declared effective at 5:00 p.m., Eastern
Time, on Thursday, May 7, 2015, or as soon thereafter as practicable.
Pursuant to Rule
460 under the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably
anticipated to be invited to participate in the distribution of the security, as many copies of the proposed form of preliminary
prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned,
as the representative of the underwriters, represent that the underwriters have and will comply with the requirements of Rule 15c2-8
under the Securities Exchange Act of 1934, as amended.
Very truly yours,
AEGIS CAPITAL CORP.
As Representative of the several underwriters named in
Schedule I to the Underwriting Agreement
By:
AEGIS CAPITAL CORP.
By:
/s/ Anthony Monaco
Name: Anthony M. Monaco
Title: Chief Compliance Officer
2015-05-06 - CORRESP - Scinai Immunotherapeutics Ltd.
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May 6, 2015
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-4561
Attention: Matthew Jones
Re:
Biondvax Pharmaceuticals Ltd.
Registration Statement
on Form F-1
Filed May 6, 2015
File No. 333-201283
Dear Mr. Jones:
BiondVax Pharmaceuticals
Ltd. (the “Company”) hereby requests acceleration of the effective date of the above-referenced Registration
Statement so that such Registration Statement shall become effective on May 7, 2015, at 5:00 p.m., Eastern Daylight Time, or as
soon thereafter as is practicable.
The Company hereby acknowledges that:
●
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.
Very truly yours,
/s/ Ron Babecoff
Ron Babecoff
Chief Executive Officer
2015-05-01 - CORRESP - Scinai Immunotherapeutics Ltd.
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May 1, 2015
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-4561
Attention: Matthew Jones
Re:
Biondvax Pharmaceuticals Ltd.
Registration Statement
on Form F-1
Filed April 30, 2015
File No. 333-201283
Dear Mr. Jones:
The undersigned, being
the Registrant identified in Registration Statement No. 333-201283 requests to cancel its acceleration request submitted to the
Securities and Exchange Commission on April 28, 2015.
Very truly yours,
/s/ Ron Babecoff
Ron Babecoff
Chief Executive Officer
2015-05-01 - CORRESP - Scinai Immunotherapeutics Ltd.
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AEGIS
CAPITAL CORP.
810
Seventh Avenue
18th
Floor
New York,
NY 10019
May
1,
2015
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
BiondVax Pharmaceuticals Ltd.
Registration
Statement on Form F-1
Filed
April 30, 2015
File
No. 333-201283
Ladies and
Gentlemen:
The undersigned, as the representative of the underwriters, hereby joins in the request of BiondVax Pharmaceuticals
Ltd. to cancel the representative’s acceleration request submitted to the Securities and Exchange Commission on April 28,
2015.
Very truly yours,
AEGIS CAPITAL CORP.
By: AEGIS CAPITAL CORP.
By:
/s/ Anthony Monaco
Name: Anthony M. Monaco
Title: Chief Compliance Officer
2015-04-28 - CORRESP - Scinai Immunotherapeutics Ltd.
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April 28, 2015
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-4561
Attention: Matthew Jones
Re:
Biondvax Pharmaceuticals Ltd.
Registration Statement
on Form F-1
Filed April 28, 2015
File No. 333-201283
Dear Mr. Jones:
BiondVax Pharmaceuticals
Ltd. (the “Company”) hereby requests acceleration of the effective date of the above-referenced Registration
Statement so that such Registration Statement shall become effective on April 30, 2015, at 5:00 p.m., Eastern Daylight Time, or
as soon thereafter as is practicable.
The Company hereby acknowledges that:
●
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.
Very truly yours,
/s/ Ron Babecoff
Ron Babecoff
Chief Executive Officer
2015-04-28 - CORRESP - Scinai Immunotherapeutics Ltd.
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AEGIS
CAPITAL CORP.
810
Seventh Avenue
18th
Floor
New
York, NY 10019
April
28, 2015
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Biondvax
Pharmaceuticals Ltd.
Registration
Statement on Form F-1
Filed
April 28, 2015
File
No. 333-201283
Ladies
and Gentlemen:
In
accordance with the above-referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations of
the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned,
as the representative of the underwriters (the “Representative”), hereby join in the request of Biondvax Pharmaceuticals
Ltd. that the effective date of the above-referenced Registration Statement be accelerated so that it will be declared effective
at 5:00 p.m., Eastern Time, on Thursday, April 30, 2015, or as soon thereafter as practicable.
Pursuant
to Rule 460 under the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably
anticipated to be invited to participate in the distribution of the security, as many copies of the proposed form of preliminary
prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The
undersigned, as the representative of the underwriters, represent that the underwriters have and will comply with the requirements
of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very
truly yours,
AEGIS
CAPITAL CORP.
As
Representative of the several underwriters named in
Schedule
I to the Underwriting Agreement
By:
AEGIS CAPITAL
CORP.
By:
/s/
Anthony Monaco
Name: Anthony
M. Monaco
Title: Chief
Compliance Officer
2015-04-24 - CORRESP - Scinai Immunotherapeutics Ltd.
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AEGIS CAPITAL
CORP.
810
Seventh Avenue
18th
Floor
New
York, NY 10019
April
24, 2015
VIA
EDGAR
United States
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Biondvax Pharmaceuticals Ltd.
Registration
Statement on Form F-1
Filed
April 8, 2015
File
No. 333-201283
Ladies and
Gentlemen:
In
accordance with the above-referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations of
the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned,
as the representative of the underwriters (the “Representative”), hereby join in the request of Biondvax Pharmaceuticals
Ltd. that the effective date of the above-referenced Registration Statement be accelerated so that it will be declared effective
at 5:00 p.m., Eastern Time, on Tuesday, April 28, 2015, or as soon thereafter as practicable.
Pursuant
to Rule 460 under the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably
anticipated to be invited to participate in the distribution of the security, as many copies of the proposed form of preliminary
prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The
undersigned, as the representative of the underwriters, represent that the underwriters have and will comply with the requirements
of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very
truly yours,
AEGIS
CAPITAL CORP.
As
Representative of the several underwriters named in
Schedule
I to the Underwriting Agreement
By:
AEGIS
CAPITAL CORP.
By:
/s/
Anthony Monaco
Name:
Anthony M. Monaco
Title:
Chief Compliance Officer
2015-04-24 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP
1
filename1.htm
April 24, 2015
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-4561
Attention: Matthew Jones
Re: Biondvax Pharmaceuticals Ltd.
Registration Statement on Form
F-1
Filed April 8, 2015
File No. 333-201283
Dear Mr. Jones:
BiondVax Pharmaceuticals Ltd. (the “Company”)
hereby requests acceleration of the effective date of the above-referenced Registration Statement so that such Registration Statement
shall become effective on April 28, 2015, at 5:00 p.m., Eastern Daylight Time, or as soon thereafter as is practicable.
The Company hereby acknowledges that:
● 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.
Very truly yours,
/s/ Ron Babecoff
Ron Babecoff
Chief Executive Officer
2015-04-06 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP
1
filename1.htm
April 6,
2015
VIA
EDGAR AND FEDERAL EXPRESS
Securities
and Exchange Commission
Division
of Corporation Finance
100 F Street,
NE
Washington,
DC 20549
Attn: Jeffrey
P. Riedler, Assistant Director
Re:
BiondVax
Pharmaceuticals Ltd.
Registration
Statement on Form F-1
Filed
December 29, 2014
File
No. 333-201283
Dear
Mr. Riedler:
On
behalf of BiondVax Pharmaceuticals Ltd., an Israeli company publicly traded on The Tel-Aviv Stock Exchange Ltd. (the “Company”),
I am writing to respond to the comments of the staff (the “Staff”) of the United States Securities and Exchange
Commission (the “SEC”) contained in its letter to the Company, dated January 15, 2015, regarding the Company’s
Registration Statement on Form F-1, filed with the SEC on December 29, 2014 (File No. 333-201283) (the “Registration
Statement”).
Concurrently
with this response, the Company is also publicly filing Amendment No. 1 to the Registration Statement (the “Amendment
No. 1”), which reflects the revisions to the Registration Statement described herein. To expedite your review, we have
enclosed with this letter a clean copy of Amendment No. 1, as well as a marked copy of Amendment No. 1 showing all changes from
the Registration Statement.
For
your convenience, we have set forth the text of each of the Staff’s comments in bold, followed in each case by the Company’s
response thereto.
Risk
Factors, page 6
1. We
note your response to prior comment 12. Please expand your disclosure on page 6 to include
a bullet point stating that your U.S. shareholders may suffer adverse tax consequences
if you are characterized as a passive foreign investment company.
Company's
response:
In
response to the Staff’s comment, the Company has expanded the disclosure on page 6 to include a bullet point stating that
its U.S. shareholders may suffer adverse tax consequences if the Company is characterized as a passive foreign investment company.
Compensation,
page 88
2. Please
update your executive and director compensation disclosure to include the registrant’s
last completed fiscal year. You should continue to provide 2013 executive compensation
information.
Company's
response:
In
response to the Staff’s comment, the Company has updated the executive and director compensation disclosure on page 94 of
the prospectus to include compensation information with respect to the last completed fiscal year in addition to 2013 executive
compensation information.
*
* * * *
In
addition to the revisions included in the Registration Statement in response to the Staff’s comments and certain non-substantive
conforming changes, the Company has revised the Registration Statement to: (1) replace the financial statements with audited annual
financial statements for the fiscal years ended December 31, 2012, 2013 and 2014; (2) include a disclosure 0n pages 23 and 88 of
the prospectus regarding the cancellation of a Consulting Services Agreement; (3) reflect the resignation of Benad Goldwasser
from our board of directors on January 8, 2015 and the passing of our advisory board member Prof. Eitan Rubinstein; (4) include
disclosure on pages 93-94 and 96 of the prospectus regarding the compensation of certain members of the board and Chief Scientific
Officer Tamar Ben Yedidia; (5) update the information contained on page 138 of the prospectus regarding the underwriting and related
arrangements for the offering; (6) include certain additional exhibits not included with the Registration Statement; (7) include
a revised auditor’s consent reflecting the date of filing of Amendment No. 1; and (8) reflect events since the filing of
the Registration Statement. In addition, attached to this letter as Appendix A are visual information to be provided
in the printed prospectus.
*
* * * *
On
behalf of the Company, I acknowledge that:
● should
the SEC or the Staff, acting pursuant to delegated authority, declare the filing effective,
it does not foreclose the SEC from taking any action with respect to the filing;
● the
action of the SEC 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 SEC or any person under the federal securities laws
of the United States.
We
appreciate your time and attention to the Company’s responses to the Staff’s comments. If you have any questions regarding
this response, please call the Company’s outside counsel, Ilan Gerzi, Adv. of Pearl Cohen Zedek Latzer Baratz at +972 (3)
607-3777, or Victor F. Semah, Esq. of Greenberg Traurig, P.A. at (305) 579-7897.
Sincerely,
/s/
Ron Babecoff
Ron
Babecoff
Chief
Executive Officer
Cc:
Ilan
Gerzi, Adv.
Tammy
Zoppo, Esq.
Pearl
Cohen Zedek Latzer Baratz
David
Gitlin, Esq.
Victor
F. Semah, Esq.
Greenberg
Traurig, P.A.
2
Appendix
A
Universal Pandemic
Primer Indication
3
The following graph demonstrates our pandemic preparedness plan according to this indication:
4
2015-01-12 - UPLOAD - Scinai Immunotherapeutics Ltd.
January 12, 2015 Via E -mail Ron Babecoff Chief Executive Officer BiondVax Pharmaceuticals Ltd. 14 Einstein Street Nes Ziona, Israel 74036 Re: BiondVax Pharmaceuticals Ltd. Registration Statement on Form F -1 Filed December 29, 2014 File No. 333 -201283 Dear Dr. Babecoff : 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. Risk Factors, page 6 1. We note your response to prior comment 12. Please expand your disclosure on page 6 to include a bullet point stating that yo ur U.S. shareholders may suffer adverse tax consequences if you are characterized as a passive foreign investment company. Compensation, page 88 2. Please update your executive and director compensation disclosure to include the registrant’s last completed fiscal year. You should continue to provide 2 013 executive compensation information . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in Ron Babecoff BiondVax Pharmaceuticals Ltd. January 12, 2015 Page 2 possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event y ou request acceleration of the effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should 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 t o 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 refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Sasha Parikh at (202) 551 -3627 or Mark Brunhofer at (202) 551 -3638 if you have questions regarding comments on the financial statements and related matters. Please contact M atthew Jones at (202) 551 -3786, John Krug at (202) 551 -3862, or me at (202) 551 - 3715 with any other questions. Sincerely, /s/ Jeffrey P . Riedler Jeffrey P. Riedler Assistant Director Ron Babecoff BiondVax Pharmaceuticals Ltd. January 12, 2015 Page 3 cc: Ilan Gerzi, Adv. Tammy Zoppo, Esq. Pearl Cohen Zedek Latzer Baratz One Azrieli Center, Round Tower, 18th Floor Tel-Aviv 6702101, Israel
2014-12-29 - CORRESP - Scinai Immunotherapeutics Ltd.
CORRESP
1
filename1.htm
December
29, 2014
VIA
EDGAR AND FEDERAL EXPRESS
Securities
and Exchange Commission
Division
of Corporation Finance
100 F Street,
NE
Washington,
DC 20549
Attn: Jeffrey
P. Riedler, Assistant Director
Re: BiondVax
Pharmaceuticals Ltd.
Draft Registration Statement
on Form F-1
Submitted November 13, 2014
CIK No. 0001611747
Dear
Mr. Riedler:
On
behalf of BiondVax Pharmaceuticals Ltd., an Israeli company publicly traded on The Tel-Aviv Stock Exchange Ltd. (the “Company”),
I am writing to respond to the comments of the staff (the “Staff”) of the United States Securities and Exchange
Commission (the “SEC”) contained in its letter to the Company, dated December 10, 2014, regarding the Company’s
Draft Registration Statement on Form F-1, confidentially submitted with the SEC on November 13, 2014 (CIK No. 0001611747) (the
“DRS”).
Concurrently
with this response, the Company is also publicly filing a Registration Statement on Form F-1 (the “Registration Statement”),
which reflects the revisions to the DRS described herein. To expedite your review, we have enclosed with this letter a clean copy
of Registration Statement, as well as a marked copy of the Registration Statement showing all changes from the DRS.
For
your convenience, we have set forth the text of each of the Staff’s comments in bold, followed in each case by the Company’s
response thereto.
Form
F-1
1. We
note the following press releases which allude to a proposed public offering of your
securities:
● the
press release labeled “Universal flu vaccine co BiondVax Pharmaceuticals mulls
NY IPO” published by BioSpace and dated November 24, 2014 (see http://www.biospace.com/news_story.aspx?StoryID=355871);
and
● the
press release labeled “Universal flu vaccine co BiondVax mulls NY IPO; BiondVax
is exploring two options - either a conventional offering or listing American Depositary
Receipts” published by Israel’s Business Arena and dated November 23, 2014
(see http://www.globes.co.il/en/article-universal-flu-vaccine-developer-biondvax-mulls-ny-ipo-1000988429).
Please
provide us with your legal analysis explaining why these communications are permissible in light of the requirements of the Securities
Act of 1933 regarding pre-filing communications. In addition, please advise us of any steps that you have taken to prevent the
further distribution or publication of similar communications going forward. For guidance, please refer to SEC Release No. 33-8591.
Company's
response:
The
Globes and BioSpace Articles
The
Company respectfully submits to the Staff that the Globes and BioSpace articles do not constitute a violation of the Securities
Act of 1933 (the “Securities Act”) by the Company.
Section
5 of the Securities Act prohibits the making of an offer to sell securities outside of a prospectus that meets the requirements
of Section 10 of the Securities Act. Section 2(a)(3) of the Securities Act defines an “offer to sell” a security as
including “every attempt or offer to dispose of, or solicitation of an offer to buy, a security or interest in a security,
for value.” The Securities and Exchange Commission has broadly construed the term “offer” to include many types
of public communications that have the intent or effect of promoting a company to prospective investors or otherwise arousing
interest in a company or its securities.
The
Company respectfully submits that the articles do not constitute an “offer to sell” the securities by the Company
or its authorized representatives because they were not communications made by or on behalf of the issuer with an intent to promote
the Company or the offering. Rather, these articles are speculative news articles published by independent third party news organizations
without any input or cooperation from the Company. In support of the foregoing, the Company confirms to the Staff that:
i.
No
individual employed by or otherwise acting on the Company’s behalf was authorized by the Company to speak to Globes,
BioSpace or any member of the press about the Company’s proposed offering.
ii.
A
few hours before the issuance of the Globes article, a reporter from Globes contacted the Company soliciting information and comment
from the Company about the offering and informing the Company of the information that such Globes reporter had obtained from anonymous
sources. The Company declined to comment and did not provide any information to Globes.
iii.
The Company
requested that the Globes reporter identify her sources. However, the Globes reporter declined to provide this information to
the Company.
iv.
Subsequent
to the issuance of the Globes article, the Company made inquiries of each of its employees, consultants, outside United States
counsel, outside Israeli counsel, the proposed underwriter for the offering, the proposed underwriter's counsel, and the Company’s
independent registered public accounting firm and received confirmations from each such party that it is not, and is not aware
of the identity of, the anonymous source of the information cited in the Globes article.
v.
The
Company determined not to repeat the procedures described in ii through iv above with respect to the BioSpace article as that
article did not provide any new information or reporting but merely summarized the Globes article published one day prior.
2
vi.
The Globes article contained very limited information and inaccurate facts. For example, the Globes article states that the Company would be required to file a prospectus with the Commission in connection with the offering. However, the Company had confidentially submitted a draft registration statement to the Commission ten days prior to the date of the article. Furthermore, while the article included a speculative statement that the Company was “exploring two options either a conventional offering or listing American Depositary Receipts (ADR) for trading”, in fact as of the date of the article the Company had already determined to conduct an offering of American Depositary Receipts and indicated such throughout its draft registration statement confidentially submitted to the Commission. The Company respectfully submits that the foregoing inaccuracies strongly imply that the sources cited in the article were speculating and did not have reliable information available to them.
vii.
In light of the publication of the articles
and its obligations under Section 5 of the Securities Act, the Company has not publicly acknowledged or confirmed that it is proposing
to conduct an offering in the United States or that it has filed a confidential registration statement for such purpose.
In light of the foregoing, the Company respectfully
submits to the Staff that neither of the Globes or BioSpace articles resulted in a violation of Section 5 of the Securities Act
by the Company because the Company did not make statements, give interviews or otherwise provide information to Globes or BioSpace
in connection with the articles, nor did it authorize any party to do so on its behalf. In addition, the Company respectfully
submits that it does not believe that there has been any market conditioning effect as a result of these articles, as the Company
and the underwriters have not received any indications of interest from potential investors as a result of the articles. Finally,
while the timing of the offering has not been determined, it is clear that additional time will pass before the offering is completed.
In connection therewith, each potential investor will receive a prospectus that complies with Section 10 of the Securities Act
prior to making an investment decision.
Steps
Taken to Prevent Offers in Violation of Section 5
The Company assures the Staff that it takes
very seriously the requirements of Section 5 of the Securities Act, including the rules and regulations promulgated thereunder,
and has taken the following steps to prevent impermissible publicity during the registration process.
i.
The Company’s management has educated itself of the restrictions on publicity applicable during the registration process through in person meetings with its outside United States and outside Israeli counsel during which such counsel instructed the Company’s management regarding the restrictions on publicity during the public offering process and suggested controls and processes to prevent unauthorized publicity.
ii.
The Company’s management team received written materials from its outside United States counsel regarding
the restrictions on corporate communications that apply to the Company while it is in registration and has provided a summary of
such materials to each of its officers, directors and those employees who has been made aware of the proposed offering.
iii.
The Company has disclosed detailed information concerning the proposed offering to only a limited number of employees, in order to limit the risk that information concerning the offering would be disclosed without authorization. In addition, the Company’s management stressed to all employees the importance of maintaining in confidence any information concerning the proposed offering and reminded such employees of their obligations under their existing confidentiality agreements with the Company.
3
iv.
To ensure compliance with Section 5 of the Securities Act, the Company requires that all press releases and
other public announcements, presentations or communications (including those issued or made in the ordinary course) to be issued
or made by the Company during the registration process must first be approved by the CEO and reviewed for compliance purposes by
the Company’s outside United States and Israeli counsel, the proposed underwriter for the offering and counsel to the underwriter.
About
This Prospectus, page i
2. Please
note that it is not appropriate to directly or indirectly disclaim liability for information
in the registration statement. Please remove the following statements:
● “However,
this information may prove to be inaccurate because of the method by which some of the
data for the estimates was obtained or because this information cannot always be verified
with complete certainty due to the limits on the availability and reliability of raw
data, the voluntary nature of the data gathering process and other limitations and uncertainties.
As a result, the market and industry data and forecasts included in this prospectus,
and estimates and beliefs based on that data, may not be reliable.”
● “However,
we have not independently ascertained the accuracy, completeness or reliability of the
underlying economic assumptions relied upon therein.”
Company's
response:
In
response to the Staff’s comment, the Company has deleted the foregoing statements from the Registration Statement.
Prospectus
Summary, page 1
3. We
note on pages 1, 52, and 63 that you own or license four families of patents filed in
a large number of jurisdictions, the latest of which is expected to be in force until
2035. We also note on page 83 that your patents are expected to expire between 2019 and
2031 and that patents issued from applications that will be filed from the additional
provisional application would be due to expire in 2035. Please expand your disclosure
on pages 1, 52, and 63 to clarify when your current material patents are expected to
expire by jurisdiction and that you have not yet filed those patents that would be expected
to expire in 2035.
Company's
response:
In
response to the Staff’s comment, the Company has revised the disclosure on pages 1, 48, 58 and 78 of the prospectus to clarify
when the Company’s material owned and/or licensed patents are expected to expire in each jurisdiction, and that patents
issued from applications that will be filed from the additional provisional application would be due to expire in 2035.
4
4. We
note on pages 2 and 63 that the FDA reviewed and commented on your IND submitted in June
2013. Please expand your disclosure to include a summary of any material communications
from the FDA.
Company's
response:
In
response to the Staff’s comment, the Company has expanded the disclosure on pages 2, 58-59 and 73-74 of the prospectus to
include a summary of the Company’s material communications with the FDA.
5. Please
define “Drug Master File” the first time this term is used.
Company's
response:
In
response to the Staff’s comment, the Company has added a definition to the term “Drug Master File” on page 2
of the prospectus.
6. We
note on page 2 that you experienced difficulties in obtaining H5N1 avian flu vaccine.
Please expand your disclosure to discuss the reason that this difficulty prevented you
from completing the IND application. Additionally, please expand your disclosure to explain
when and how you acquired access to the H5N1 avian flu vaccine.
Company's
response:
In
response to Staff’s comment, the Company has expanded the disclosure on pages 2, 58-59 and 73-74 of the prospectus to include
the reason the difficulties in obtaining H5N1 prevented the Company from completing the IND application. In addition, in response
to Staff's comment, the Company expanded the disclosure on pages 2, 58-59 and 73-74 of the prospectus to clarify that the Company
did not at any time acquire access to H5N1 avian flu vaccine.
7. We
note on page 2 that you plan to seek to establish collaborations with large multinational
pharmaceutical companies and/or national health authorities to conduct Phase 3 clinical
trials of M-001. We also note throughout your prospectus that you plan to conduct Phase
3 clinical trials in the U.S. For example, on page 5 you state that you plan to “conduct
Phase 3 clinical trials” and “perform advanced trials (including Phase 3
clinical trials).” Please revise your disclosure throughout your prospectus to
clarify the extent to which you intend to rely on a collaborator to conduct or aid in
2014-12-11 - UPLOAD - Scinai Immunotherapeutics Ltd.
December 10 , 2014 Via E -mail Ron Babecoff Chief Executive Officer BiondVax Pharmaceuticals Ltd. 14 Einstein Street Nes Ziona, Israel 74036 Re: BiondVax Pharmaceuticals Ltd. Draft Registration Statement on Form F -1 Submitted November 13, 2014 CIK No. 0001611747 Dear Dr. Babecoff : 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 circumst ances 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. Form F -1 1. We note the following press releases which allude to a proposed publi c offering of your securities: the press release labeled “Universal flu vaccine co BiondVax Pharmaceuticals mulls NY IPO” published by BioSpace and dated November 24, 2014 (see http://www.biospace.com/news_story.aspx?StoryID=355871 ); and the press release labeled “Universal flu vaccine co BiondVax mulls NY IPO; BiondVax is exploring two options - either a conventional offering or listing American Depositary Receipts” published by Israel ’s Business Arena and dated November 23, 2014 (see http://www.globes.co.il/en/article -universal -flu-vaccine - developer -biondvax -mulls -ny-ipo-1000988429 ). Ron Babecoff BiondVax Pharmaceuticals Ltd. December 10 , 2014 Page 2 Please provide us with your legal analysis explaining why these c ommunications are permissible in light of the requirements of the Securities Act of 1933 regarding pre-filing communications. In addition , please a dvise us of any steps that you have taken to prevent the further distribution or publication of similar communications going forw ard. For guidance, please refer to SEC Release No. 33 -8591. About This Prospectus, page i 2. Please note that i t is not appropriate to directly or indirectly disclaim liability for information in the registration statement. Please remove the follow ing statements: “However, this information may prove to be inaccurate because of the method by which some of the data for the estimates was obtained or because this information cannot always be verified with complete certainty due to the limits on the ava ilability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties. As a result, the market and industry data and forecasts included in this prospectus, and estimates and beliefs based on that data, may not be reliable. ” “However, we have not independently ascertained the accuracy, completeness or reliability of the underlying economic assumptions relied upon therein. ” Prospectus Summary, page 1 3. We note on pages 1, 52, and 63 that you own or l icense four families of patents filed in a large number of jurisdictions, the latest of which is expected to be in force until 2035. We also note on page 83 that your patents are expected to expire between 2019 and 2031 and that p atents issued from applic ations that will be filed from the additional provisional application would be due to expire in 2035 . Please expand your disclosure on pages 1, 52, and 63 to clarify when your current material patents are expected to expire by jurisdiction and that you ha ve not yet filed those patents that would be expected to expire in 2035. 4. We note on pages 2 and 63 that the FDA reviewed and commented on your IND submitted in June 2013. Please expand your disclosure to include a summary of any material communications from the FDA. 5. Please define “Drug Master File” the first time this term is used. 6. We note on page 2 that you experienced difficultie s in obtaining H5N1 avian flu vaccine. Please expand your disclosure to discuss the reason that this difficulty prevente d you from completing the IND application. Additionally, please expand your disclosure to explain when and how you acquired access to the H5N1 av ian flu vaccine. Ron Babecoff BiondVax Pharmaceuticals Ltd. December 10 , 2014 Page 3 7. We note on page 2 that you plan to seek to establish collaborations with large multinational pharmaceutical companies and/or national health authorities to conduct Phase 3 clinical trials of M -001. We also note throughout your prospectus that you plan to conduct Phase 3 clinical trials in the U.S. For example, on page 5 you state that you plan to “conduct Phase 3 clinical trials” and “perform advanced trials (including Phase 3 clinical trials).” Please revise your disclosure throughout your prospectus to clarify the extent to which you int end to rely on a collaborator to conduct or aid in the completion of certain Phase 3 clinical trials. 8. We note on page 4 that you expect your future sales not to be limited to the influenza seasons. Please expand your disclosure to discuss the potential s easonality for sales of M-001 as a universal seasonal primer for the elderly or as a universal pandemic primer indication. 9. We note that in several places in your prospectus in which you characterize the drug as “safe” or “effective.” For example, on page s 4 and 66, you refer to an “effective dose;” on pages 5 and 67, you state that the trial results “show that M -001 was safe across all treatment groups;” and on page 69 you state that preclinical trials have “demonstrated that M -001 provides an effective f lue protection.” Because regulatory approval of M -001 is dependent on the agency making a determination (according to criteria specified in law and agency regulations) that a drug is safe and effective, it is premature for you to describe M-001, or any of the dosages administered, as safe or effective . Accordingly, please delete this wording throughout your prospectus, as applicable. Risk Factors We have only conducted Phase 1 and Phase 2 clinical trials , page 18 10. We note on page 18 that you state that you have never submitted an IND application to conduct a Phase 3 clinical trial in the U.S. Please expand your disclosure to identify and discuss your IND application submitted in June 2013. International patent protection is particularly uncertain, pag e 29 11. We note that you have licensed or own patents that were granted in China ( see p. 83). Accordingly, identify China as one of those foreign countries that may not protect your intellectual property rights to the same extent as the United States. Our U.S. shareholders may suffer adverse tax consequences, page 35 12. Please explain why you are unable to determine if you are a PFIC for any year. Additionally, please briefly explain that U.S. shareholders may be required to file additional forms with the IR S. Ron Babecoff BiondVax Pharmaceuticals Ltd. December 10 , 2014 Page 4 We are a “foreign private issuer” and have disclosure obligations that are different from those of U.S. domestic reporting companies , page 36 13. The Israeli parliament recently adopted a rule that requires an Israeli public company that is listed overs eas, such as in the United States, to disclose annually the compensation of its top five executive officers on an individual basis regardless of whether the company is listed in Israel. Please revise this risk factor to reflect this new rule. Further cla rify how, despite this new rule, as a foreign private issuer, you will not be required to provide in your Exchange Act reports “individual executive compensation information that is as detailed as that required of U.S. domestic reporting companies.” Use of Proceeds, page 44 14. We note that subject to FDA approval to commence Phase 3 clinical trials, you plan to allocate approximately $2 million for the manufacturing of clinical grade Phase 3 vaccine batches and commercial batches over a period of 3 years. We also note on page 64 that you may seek to finance Phase 3 clinical trials of M -001 for some indications with your own resources, if sufficient. Please clarify your plans to allocate any of the proceeds from this offering to certain Phase 3 trials by in dication, and state whether such allocation is expected to be sufficient to complete the respective Phase 3 trial. Capitalization, page 46 15. Please revise the presentation of this table to remove cash and cash equivalents, or alternatively clearly indicate that it is not a component of capitalization by adding an underline or double underline under the amounts as well as a blank line. Business , page 63 16. We note on page 64 that you intend to seek to establish collaborations with large multinational pharmace utical companies and/or national health authorities to conduct Phase 3 clinical trials of M -001. Please expand your disclosure to discuss when you plan to seek out a collaborator and your reliance on finding a collaborator for purposes of developing M -001. 17. We note that you completed your BVX -005 Phase 2 trial in February 2012. Please expand your disclosure to discuss your operations and principal activities for the prior two fiscal years ending in December 31, 2013 and the interim period. Current Outlo ok, page 57 18. Please file the your OCS grants as exhibits pursuant to Item 601(b)(10) of Regulation S-K. Ron Babecoff BiondVax Pharmaceuticals Ltd. December 10 , 2014 Page 5 Universal Standalone Indication, page 67 19. We note your statement that “these rates in the general and elderly populations will increase considerably, as doctors and patients become aware of the increased effectiveness of [y]our product.” Please revise this statement to consider the risks of commercialization and competition, as well as expand on the risk that doctors may not find your product sufficien tly effective, even if the FDA approves your product. Other Product Candidates to be Developed, page 69 20. We note a rece nt press release from MonoSol RX stating that you have entered into a partnership. See http://www.monosolrx.com/content/media/releases/news_110712.htm . Please revise your disclosure to clarify whether you have entered into any such collaboration agreement with MonoSol RX. Additionally, if material, please expand your disclosure to discuss t he material terms of this agreement, including whether the agreement is exclusive, material payment obligations, the duration, and material termination provisions. Please also file the agreement as an exhibit. Safety and Efficacy Preclinical Trials, page 69 21. Please expand your disclosure to clarify that the safety and efficacy of your product for human patients cannot be determined based on preclinical trials. Results of our Clinical Trials, page 71 22. We note on page 1 that for your Phase 1/2 clinical trials you tested for both safety of M - 001 as your primary endpoint and immunogenicity of M -001 as your secondary endpoint. We also note on page 71 and 72 that clinical trials BVX -002, BVX -003, and BVX -004 were aimed at “assessing the safety and tolerabil ity of M -001.” Please revise your disclosure to clarify whether these clinical trials tested for immunogenicity or any other primary or secondary endpoints. Additionally, if your clinical trials tested for any additional endpoints, please expand your dis closure to discuss the material results of your studies. BVX -005, page 72 23. Please include a description of the goals of the trial, the primary endpoints and any secondary endpoints, and any additional results obtained. Additionally, please expand your d isclosure to discuss the significance of an increase in the proportions of interferon gamma secreting cells and influenza antigens. Also, please define influenza antigens the first time this term is used. Ron Babecoff BiondVax Pharmaceuticals Ltd. December 10 , 2014 Page 6 Future Phase 3 Clinical Trials, page 73 24. We note that you may initiate Phase 3 trials for some or all of your indications. Please expand your disclosure to state how you plan to prioritize which Phase 3 trials you will perform or the order that you will perform them. Grant from the European Union, pag e 77 25. We note your statement on page 77 that you have entered into a framework agreement which defines the Consortium rules of conduct as well as conditions under which you are receiving €0.5 million . Please expand your summary to disclose the material ru les and conditions of the framework agreement. Intellectual Property, page 83 26. We note that your patents are expected to expire between 2019 and 2031 . Please expand your disclosure to clarify when your patents are expected to expire in each of your material jurisdictions. 27. We note that you have licensed two families of patents and also that you have licensed three families of patents from Yeda. Please revise your disclosure to clarify the number of families of patents that you have licensed. Management Compensation, page 92 28. Disclose the total amount set aside or accrued by you to provide pension, retirement or other similar benefits for your executive officers and directors during the most recently completed fiscal year. See Item 6.B.2. of F orm 20 -F. Board Practices, page 97 29. Please expand your disclosure to provide the details of your directors’ service contracts with the company that provide for benefits upon termination of employment or an appropriate negative statement. Shares Eligible for Future Sale Rule 144, page 127 30. Please state the number of your ordinary shares that will be restricted securities under Rule 144 upon completion of this offering. Ron Babecoff BiondVax Pharmaceuticals Ltd. December 10 , 2014 Page 7 Taxation U.S. Federal Income Tax Consequences, page 130 31. Please d elete your disclaimer that the tax “summary is for general purposes only and does not constitute tax advice” as it improperly implies that an investor may not rely on the U.S. tax information disclosed in the registration statement. Where You Ca n Find More Information, page 145 32. We note your disclosure that you have filed Hebrew language periodic and immediate reports with the TASE and the ISA, as required under the Israel Securities Law. Further disclose that, as an Exchange Act reporting foreign private issuer, you will be requ ired to furnish to the SEC under Form 6 -K English translations or, in certain instances, English summaries of your material home country documents. See Exchange Act Rule 12b -12(d). Notes to Financial Statements 33. It appears that there are some inconsistenc ies regarding the numerical values indicated in the footnotes as being “in thousands, except per share data”. For instance, on page F -38 in Note 14d you indicate that you entered into an agreement for the sale of up to $7,000,000 of your ordinary shares. I n this regard, it would appear that the agreement was for $7 billion. Please revise the notes to financial statements for consistency. Note 14. Equity, page F -37 34. It appears that your series 3 and series 5 options have variable exercise terms. Please tel l us your accounting basis for classifying these options as equity. Reference for us the authoritative guidance you relied upon to support your accounting and classification. Exhibit Index 35. Please file the amendment to the employment agreements between th e company and Mr. Uri Ben Or as an exhibit pursuant to Item 601(b)(10) of Regulation S -K. 36. Please file the employment agreement between the company and each member of the Scientific Advisory Team as an exhibit . General 37. Please file all exhibits as soon as practicable. We may have further comments upon examination of these exhibits. Ron Babecoff Biond