SEC Comment Letter 0000000000-25-001867 to Nasus Pharma Ltd (NSRX)
Nasus Pharma Ltd
Date: Feb. 18, 2025 · CIK: 0002029039 · Accession: 0000000000-25-001867
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Letter
February 18, 2025 Udi Gilboa Executive Chairman Nasus Pharma Ltd. Yigal Alon 65 Tel Aviv, Israel 6744317 Re:Nasus Pharma Ltd. Amendment No. 2 to Draft Registration Statement on Form F-1 Submitted February 6, 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 January 28, 2025 letter. Amendment No. 2 to Draft Registration Statement on Form F-1 Cover Page 1.We note your revisions to the prospectus cover page. Please revise your cover page to reflect your disclosure on page 164 that you will be issuing warrants to the underwriters' representative as part of the underwriting compensation. Business Our Phase 2 dose-finding/safety study -- NP006, page 92 We note your response to prior comment 7 and revised disclosure. Please further revise your discussion of your Phase 2 trial to clarify, if true, that in trials not powered 2.
February 18, 2025 Page 2 for statistical significance, there is a high chance that observed effects may not be real due to small sample size. Please similarly revise your discussion of NS001 as compared to Narcan on page 99. Competition, page 100 3.We note your response to prior comment 9 and revised disclosure. However, we further note that you have retained your graphic on page 101 and your statement on page 95 claiming that NS001 creates significantly higher plasma levels of naloxone in the blood as compared to 8 mg dosage of Narcan and Kloxxado. Given that this graphic and this statement do not appear to be based on head-to-head trials, please remove them. 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.
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February 18, 2025
Udi Gilboa
Executive Chairman
Nasus Pharma Ltd.
Yigal Alon 65
Tel Aviv, Israel 6744317
Re:Nasus Pharma Ltd.
Amendment No. 2 to Draft Registration Statement on Form F-1
Submitted February 6, 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 January 28, 2025 letter.
Amendment No. 2 to Draft Registration Statement on Form F-1
Cover Page
1.We note your revisions to the prospectus cover page. Please revise your cover page to
reflect your disclosure on page 164 that you will be issuing warrants to the
underwriters' representative as part of the underwriting compensation.
Business
Our Phase 2 dose-finding/safety study -- NP006, page 92
We note your response to prior comment 7 and revised disclosure. Please further
revise your discussion of your Phase 2 trial to clarify, if true, that in trials not powered 2.
February 18, 2025
Page 2
for statistical significance, there is a high chance that observed effects may not be real
due to small sample size. Please similarly revise your discussion of NS001 as
compared to Narcan on page 99.
Competition, page 100
3.We note your response to prior comment 9 and revised disclosure. However, we
further note that you have retained your graphic on page 101 and your statement on
page 95 claiming that NS001 creates significantly higher plasma levels of naloxone in
the blood as compared to 8 mg dosage of Narcan and Kloxxado. Given that this
graphic and this statement do not appear to be based on head-to-head trials, please
remove them.
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.