SecProbe.io

January 28, 2025
Udi Gilboa
Executive Chairman
Nasus Pharma Ltd.
Yigal Alon 65
Tel Aviv, Israel 6744317
Re:Nasus Pharma Ltd.
Amendment No. 1 to Draft Registration Statement on Form F-1
Submitted December 31, 2024
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 September 27, 2024 letter.
Amendment No. 1 to Draft Registration Statement on Form F-1
Prospectus Summary
Our Company, page 1
1.We note your response to prior comment 1 and revised disclosure, here and
elsewhere, indicating that you plan to conduct two additional Phase 2 studies of
NS002 "prior to submission for marketing approval." Please revise here and
elsewhere, as appropriate, to clarify if you will be permitted to submit an NDA for
NS002 directly after your two additional Phase 2 studies are completed, or whether
you will be required to wait until you complete a pivotal clinical trial in addition to
other testing before submitting an NDA.

January 28, 2025
Page 2
2.We note your response to prior comment 2 and reissue in part. Please revise your Our
Company section to disclose that the FDA may not agree that your product candidates
satisfy the requirements for the Section 505(b)(2) regulatory approval. Alternatively,
please advise.
Business
The Intranasal Drug Delivery Product Market
Rise in prevalence, page 82
3.We note your response to prior comment 6 and reissue in part. We note the authority
you cite to support hospital admissions in Australia appears to be a study of the
United States population, that the authority cited for UK hospital admissions appears
to be a study of the Spanish population and that one of the authorities cited for US
hospital admissions appears to be a study of the Danish population. Please revise to
reconcile or otherwise advise.
Nasus's Well Differentiated and Diversified Technology Platform - Intranasal Powder, page
88
4.We note your response to prior comment 7 and reissue. Please revise to identify the
third-party particles depicted in the left graphic of Figure 5 on page 89.
Aptar UDS and collaboration, page 90
5.Please revise your description of the Aptar collaboration to reflect your disclosure
elsewhere in the prospectus that there is an amount of $529,000 outstanding to be paid
to Aptar, which has not been paid to date.
Intranasal Epinephrine (NS002), page 90
6.We note your response to prior comment 3 and reissue in part. Please revise to remove
the statement that "NS002 was found to be a needle-free alternative for life-
threatening anaphylaxis" as the FDA has not concluded NS002 may be used in any
indication. You may summarize the results of clinical trials without concluding as to
efficacy.
Our Phase 2 dose-finding/safety study -- NP006, page 92
7.Please revise your disclosure to explain how you found a statistically significant
difference in your studies of NS002 even though the studies were not powered for
statistical significance. Please similarly revise your disclosure on page 99.
Intranasal Naloxone (NS001), page 95
8.We note your response to prior comment 11 and reissue in part. Please revise page 99
to disclose the details of the "scientific advice request from several countries in the
European Union." We note your revised disclosure in response to prior comment
11 states you intend to have a discussion with regulatory authorities in the European
Union, but does not disclose the details of the "scientific advice request from several
countries in the European Union." Please revise to provide the requested disclosure, or
otherwise advise.

January 28, 2025
Page 3
Competition, page 100
9.We note your response to prior comment 12 and reissue in part. Please revise to
remove the comparisons between Kloxxado and NS001 as it appears these
comparisons are not the result of head-to-head clinical trials. To the extent applicable,
please similarly remove your comparisons on page 86.
Intellectual Property, page 103
10.We note your response to prior comment 13 and reissue in part. Please revise to
disclose the expiration dates for your issued patents and expected expiration dates for
your pending patents.
Research and Development, page 106
11.We note your response to prior comment 16 states you do not have any future
obligations to repay the amounts received under the non-recurring research
agreement. Please revise to state whether there are any other future obligations
pursuant to this agreement and whether you are still performing services pursuant to
the agreement.
Orange Book Listing, page 109
12.We note your response to prior comment 17 and reissue. Our comment is not meant to
relate to challenges to your intellectual property, but whether you intend to challenge
the intellectual property rights of other entities. Please disclose, if known, whether
you will need to challenge patents via a Paragraph IV certification. To the extent that
you plan to pursue this certification or there is material uncertainty, then please add a
risk factor that discusses the need or potential need for a 30-month stay on future
NDA applications that you submit for your lead candidates.
General
13.Please supplementally provide us with copies of all written communications, as
defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so
on your behalf, present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not they retain copies of the communications.
            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.