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UPLOAD Filing

Nasus Pharma Ltd
Date: April 22, 2025 · CIK: 0002029039 · Accession: 0000000000-25-004261

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
April 22, 2025
Author
Division of
Form
UPLOAD
Company
Nasus Pharma Ltd

Letter

Re: Nasus Pharma Ltd. Amendment No. 4 to Draft Registration Statement on Form F-1 Submitted April 16, 2025 CIK No. 0002029039 Dear Udi Gilboa:

April 22, 2025

Udi Gilboa Executive Chairman Nasus Pharma Ltd. Yigal Alon 65 Tel Aviv, Israel 6744317

We have reviewed your amended draft registration statement and have the following comments.

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 a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in response to this letter and your amended draft registration statement or filed registration statement, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our March 28, 2025 letter.

Amendment No. 4 to Draft Registration Statement on Form F-1 Cover Page

1. Please revise to remove the statements under the heading "Study Data & Results" in your cover page graphic that claim or imply that NS002 is superior to an approved product. You may summarize data from clinical trials without claiming that your product candidate is superior to approved products. Please also revise to clarify that NS002 has yet to be approved and that it does not currently offer "a compact, simple, and needle free alternative for rapid epinephrine delivery." April 22, 2025 Page 2 Business Research and Development, page 106

2. Please revise your pipeline table on page 107 to add separate columns for Phase 1 and Phase 2 clinical development so there are three clinical development columns. Revise the progress arrow for your NS002 program so it does not enter the pivotal trial column or through the entire Phase 2 column as your disclosure on page 106 states you have yet to complete two additional Phase 2 clinical trials. Please also remove the "NDA submission" column. You may disclose the anticipated next development step for your product candidates. Exhibits

3. We note your response to prior comment 6. We further note your risk factor on page 36 indicating that obtaining substitute components may be difficult or require you to re-design your products. In addition, your disclosure elsewhere in the prospectus indicates that Aptar provides services including studies and analytical services in connection with the developing of NS002 and that "Aptar has collaborated, supported and performed the development of [your] drug device program..." Please revise to file the Master Services Agreement and related schedules of work as exhibits to your registration statement.

Please contact Christine Torney at 202-551-3652 or Daniel Gordon at 202-551-3486 if you have questions regarding comments on the financial statements and related matters. Please contact Daniel Crawford at 202-551-7767 or Alan Campbell at 202-551-4224 with any other questions.

Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Eric Victorson, Esq.

Show Raw Text
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 April 22, 2025

Udi Gilboa
Executive Chairman
Nasus Pharma Ltd.
Yigal Alon 65
Tel Aviv, Israel 6744317

 Re: Nasus Pharma Ltd.
 Amendment No. 4 to Draft Registration Statement on Form F-1
 Submitted April 16, 2025
 CIK No. 0002029039
Dear Udi Gilboa:

 We have reviewed your amended draft registration statement and have the
following
comments.

 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 a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing the information you provide in response to this letter
and your
amended draft registration statement or filed registration statement, we may
have additional
comments. Unless we note otherwise, any references to prior comments are to
comments in
our March 28, 2025 letter.

Amendment No. 4 to Draft Registration Statement on Form F-1
Cover Page

1. Please revise to remove the statements under the heading "Study Data &
Results" in
 your cover page graphic that claim or imply that NS002 is superior to an
approved
 product. You may summarize data from clinical trials without claiming
that your
 product candidate is superior to approved products. Please also revise
to clarify that
 NS002 has yet to be approved and that it does not currently offer "a
compact, simple,
 and needle free alternative for rapid epinephrine delivery."
 April 22, 2025
Page 2
Business
Research and Development, page 106

2. Please revise your pipeline table on page 107 to add separate columns
for Phase 1 and
 Phase 2 clinical development so there are three clinical development
columns. Revise
 the progress arrow for your NS002 program so it does not enter the
pivotal trial
 column or through the entire Phase 2 column as your disclosure on page
106 states
 you have yet to complete two additional Phase 2 clinical trials. Please
also remove the
 "NDA submission" column. You may disclose the anticipated next
development step
 for your product candidates.
Exhibits

3. We note your response to prior comment 6. We further note your risk
factor on page
 36 indicating that obtaining substitute components may be difficult or
require you to
 re-design your products. In addition, your disclosure elsewhere in the
prospectus
 indicates that Aptar provides services including studies and analytical
services in
 connection with the developing of NS002 and that "Aptar has
collaborated, supported
 and performed the development of [your] drug device program..." Please
revise to file
 the Master Services Agreement and related schedules of work as exhibits
to your
 registration statement.

 Please contact Christine Torney at 202-551-3652 or Daniel Gordon at
202-551-3486
if you have questions regarding comments on the financial statements and
related
matters. Please contact Daniel Crawford at 202-551-7767 or Alan Campbell at
202-551-4224
with any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Eric Victorson, Esq.
</TEXT>
</DOCUMENT>