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Nasus Pharma Ltd
Response Received
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-08 | Company Response | Nasus Pharma Ltd | Israel | N/A | Read Filing View |
| 2025-08-08 | Company Response | Nasus Pharma Ltd | Israel | N/A | Read Filing View |
| 2025-08-07 | Company Response | Nasus Pharma Ltd | Israel | N/A | Read Filing View |
| 2025-08-06 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-07-28 | Company Response | Nasus Pharma Ltd | Israel | N/A | Read Filing View |
| 2025-07-16 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-05-20 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-05-07 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-04-22 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-03-28 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-02-18 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-01-28 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2024-09-27 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-06 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-07-16 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-05-20 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-05-07 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-04-22 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-03-28 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-02-18 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2025-01-28 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| 2024-09-27 | SEC Comment Letter | Nasus Pharma Ltd | Israel | 377-07416 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-08 | Company Response | Nasus Pharma Ltd | Israel | N/A | Read Filing View |
| 2025-08-08 | Company Response | Nasus Pharma Ltd | Israel | N/A | Read Filing View |
| 2025-08-07 | Company Response | Nasus Pharma Ltd | Israel | N/A | Read Filing View |
| 2025-07-28 | Company Response | Nasus Pharma Ltd | Israel | N/A | Read Filing View |
2025-08-08 - CORRESP - Nasus Pharma Ltd
CORRESP 1 filename1.htm Nasus Pharma Ltd. Yigal Alon 65 Tel Aviv, Israel 6744317 August 8, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: Nasus Pharma Ltd. (CIK: 0002029039) Registration Statement No. 333-288582 on Form F-1 (the "Registration Statement") Ladies and Gentlemen: Nasus Pharma Ltd. (the " Registrant ") hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities Act of 1933, as amended (the " Securities Act "), so that it may become effective on Monday August 11, 2025 at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. By separate letter, the underwriters of the issuance of the securities being registered have joined in this request for acceleration. The Registrant understands that the Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed public offering of the securities specified in the Registration Statement. The Registrant respectfully requests that it be notified of such effectiveness by a telephone call to Eric Victorson, Esq. at (212) 660-3092 of Sullivan & Worcester LLP and that such effectiveness also be confirmed in writing. Very truly yours, Nasus Pharma Ltd. By: /s/ Dan Teleman Name: Dan Teleman Title: Chief Executive Officer
2025-08-08 - CORRESP - Nasus Pharma Ltd
CORRESP 1 filename1.htm Laidlaw and Company (UK) Ltd. 521 5th Avenue, 12th Floor New York, NY 10175 August 8, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Nasus Pharma Ltd. Registration Statement on Form F-1, as amended File No. 333-288582 Acceleration Request Requested Date: Monday, August 11, 2025 Requested Time: 5:00 PM Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the "Securities Act"), Laidlaw and Company (UK) Ltd., as representative of the underwriters of the offering, hereby joins the request of Nasus Pharma Ltd., that the effective date of the above-referenced Registration Statement on Form F-1, as amended, be accelerated so that it may become effective at 5:00 p.m., Eastern Time, on Monday, August 11, 2025, 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 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 confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended. LAIDLAW AND COMPANY (UK) LTD. Very truly yours, By: /s/ Luke Kottke Name: Luke Kottke Title: Head of Capital Markets
2025-08-07 - CORRESP - Nasus Pharma Ltd
CORRESP
1
filename1.htm
Nasus
pharma ltd.
Yigal
Alon 65
Tel
Aviv, 6744317, Israel
August
7, 2025
Via
EDGAR
Daniel
Crawford
Alan
Campbell
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
DC 20549
Re:
Nasus
Pharma Ltd. (the "Company," "we," "our" and similar terminology)
Amendment
No. 1 to Registration Statement on Form F-1
Filed
July 28, 2025
File
No. 333-288582
Dear
Sirs,
The
purpose of this letter is to respond to the comment letter of August 6, 2025, received from the staff (the "Staff") of the
U.S. Securities and Exchange Commission regarding the above-mentioned Registration Statement on Form F-1. For your convenience, your
original comments appear in bold text, followed by our response. We are concurrently filing Amendment No. 2 to the Registration Statement
on Form F-1 ("Amendment No. 2").
Page
references in our responses are to Amendment No. 2. Unless otherwise stated, any defined terms in Amendment No. 2 apply within this letter.
Amendment
No. 1 to Registration Statement on Form F-1
Prospectus
Summary
Our
Company, page 1
1.
Please
revise under this heading and your Business section where appropriate to disclose whether you have filed INDs with the FDA for the
clinical trials of NS001 and NS002. If so, disclose the date each IND was filed and whether they are still active.
Response :
In response to the Staff's comment, we have revised the disclosure on pages 1, 2, 68 and 77 of Amendment No. 2 to reflect
that we have not filed INDs for either of our clinical trials of NS001 and NS002 and we intend to file an IND for our clinical trial
of NS002 in the third quarter of 2026.
Report
of Independent Registered Public Accounting Firm, page F-3
2.
Please
ensure that your independent registered public accounting firm finalizes its report prior to effectiveness.
Response :
In response to the Staff's comment, we have revised the disclosure on page F-1 of Amendment No. 2 to include the finalized
report from our independent registered public accounting firm.
Exhibits
3.
Please
provide a finalized and currently dated consent from your independent registered public accounting firm prior to effectiveness.
Response :
In response to the Staff's comment, we have provided a finalized and currently dated consent from our independent registered public
accounting firm filed as Exhibit 23.1 to Amendment No. 2.
Exhibits
4.
Please
revise your legal opinions filed as Exhibits 5.1 and 5.2 to opine on the volume of securities being registered.
Response :
The Company acknowledges the Staff's comment. However, as discussed with the Staff, the Company has calculated the registration
fee based on Rule 457(o) under the Securities Act of 1933, as amended ("Rule 457(o)"). As discussed with the Staff, the legal
opinions filed as Exhibits 5.1 and 5.2 properly refer to the proposed maximum aggregate offering price calculated pursuant to Rule 457(o).
If
you have any questions or require additional information, please contact our attorneys Eric Victorson, Esq. at (212) 660-3092 or Oded
Har-Even, Esq. at (212) 660-5002, each of Sullivan & Worcester LLP.
Sincerely,
Nasus Pharma Ltd .
By:
/s/
Udi Gilboa
Executive
Chairman
2025-08-06 - UPLOAD - Nasus Pharma Ltd File: 377-07416
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 6, 2025 Udi Gilboa Executive Chairman Nasus Pharma Ltd. Yigal Alon 65 Tel Aviv, Israel 6744317 Re: Nasus Pharma Ltd. Amendment No. 1 to Registration Statement on Form F-1 Filed July 28, 2025 File No. 333-288582 Dear Udi Gilboa: We have reviewed your amended registration statement and have the following comments. Please respond to this letter by amending your registration statement and providing the requested information. 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 any amendment to your registration statement and the information you provide in response to this letter, we may have additional comments. Amendment No. 1 to Registration Statement on Form F-1 Prospectus Summary Our Company, page 1 1. Please revise under this heading and your Business section where appropriate to disclose whether you have filed INDs with the FDA for the clinical trials of NS001 and NS002. If so, disclose the date each IND was filed and whether they are still active. Report of Independent Registered Public Accounting Firm, page F-3 2. Please ensure that your independent registered public accounting firm finalizes its report prior to effectiveness. August 6, 2025 Page 2 Exhibits 3. Please provide a finalized and currently dated consent from your independent registered public accounting firm prior to effectiveness. 4. Please revise your legal opinions filed as Exhibits 5.1 and 5.2 to opine on the volume of securities being registered. Please contact Christine Torney at 202-551-3652 or Angela Connell at 202-551-3426 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>
2025-07-28 - CORRESP - Nasus Pharma Ltd
CORRESP
1
filename1.htm
Nasus
pharma ltd.
Yigal
Alon 65
Tel
Aviv, 6744317, Israel
July
28, 2025
Via
EDGAR
Daniel
Crawford
Alan
Campbell
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
DC 20549
Re:
Nasus
Pharma Ltd. (the "Company," "we," "our" and similar terminology)
Registration
Statement on Form F-1
Filed
July 9, 2025
File
No. 333-288582
Dear
Sirs,
The
purpose of this letter is to respond to the comment letter of July 16, 2025, received from the staff (the "Staff") of the
U.S. Securities and Exchange Commission regarding the above-mentioned Registration Statement on Form F-1. For your convenience, your
original comments appear in bold text, followed by our response. We are concurrently filing Amendment No. 1 to the Registration Statement
on Form F-1 ("Amendment No. 1").
Page
references in our responses are to Amendment No. 1. Unless otherwise stated, any defined terms in Amendment No. 1 apply within this letter.
Registration
Statement on Form F-1
Business
Our
Products
Intranasal
Epinephrine (NS002), page 90
1.
We
note your revised disclosure on page 91 discussing data from your enantiomeric stability study between NS002 and Epinephrine. Please
revise to disclose additional details about this study, including the number of samples tested, the age and manufacturer of the samples,
whether the results are statistically significant and whether you can confirm the samples tested were handled, transported and stored
according to the manufacturers' specifications.
Response :
In response to the Staff's comment, we have revised the disclosure on pages 91-92 to include additional details about the enantiomeric
stability study. The revised disclosure does not include the age of the samples (other than our NS002 sample stored for 24 months), as
this data was not collected by the Company; however, the revised disclosure includes the expiration dates of the EpiPen samples used.
If
you have any questions or require additional information, please contact our attorneys Eric Victorson, Esq. at (212) 660-3092 or Oded
Har-Even, Esq. at (212) 660-5002, each of Sullivan & Worcester LLP.
Sincerely,
Nasus
pharma LTD .
By:
/s/
Udi Gilboa
Executive
Chairman
2025-07-16 - UPLOAD - Nasus Pharma Ltd File: 377-07416
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 16, 2025 Udi Gilboa Executive Chairman Nasus Pharma Ltd. Yigal Alon 65 Tel Aviv, Israel 6744317 Re: Nasus Pharma Ltd. Registration Statement on Form F-1 Filed July 9, 2025 File No. 333-288582 Dear Udi Gilboa: We have reviewed your registration statement and have the following comment. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comment 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 letter, we may have additional comments. Registration Statement on Form F-1 Business Our Products Intranasal Epinephrine (NS002), page 90 1. We note your revised disclosure on page 91 discussing data from your enantiomeric stability study between NS002 and Epinephrine. Please revise to disclose additional details about this study, including the number of samples tested, the age and manufacturer of the samples, whether the results are statistically significant and whether you can confirm the samples tested were handled, transported and stored according to the manufacturers' specifications. 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. July 16, 2025 Page 2 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. 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>
2025-05-20 - UPLOAD - Nasus Pharma Ltd File: 377-07416
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 20, 2025 Udi Gilboa Executive Chairman Nasus Pharma Ltd. Yigal Alon 65 Tel Aviv, Israel 6744317 Re: Nasus Pharma Ltd. Amendment No. 6 to Draft Registration Statement on Form F-1 Submitted May 12, 2025 CIK No. 0002029039 Dear Udi Gilboa: We have reviewed your amended draft registration statement and have the following comment. 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 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 May 7, 2025 letter. Amendment No. 6 to Draft Registration Statement on Form F-1 Cover Page 1. We note your response to prior comment 1 and revised disclosure. With reference to Question 101.02 of our Compliance and Disclosure Interpretations, Securities Act Forms, please revise your cover page disclosures indicating that trial was not powered for statistical significance and that observed effects may not be accurate due to small sample size to present them with equal prominence to your disclosures regarding study data and results. May 20, 2025 Page 2 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>
2025-05-07 - UPLOAD - Nasus Pharma Ltd File: 377-07416
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 7, 2025 Udi Gilboa Executive Chairman Nasus Pharma Ltd. Yigal Alon 65 Tel Aviv, Israel 6744317 Re: Nasus Pharma Ltd. Amendment No. 5 to Draft Registration Statement on Form F-1 Submitted April 29, 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 April 22, 2025 letter. Amendment No. 5 to Draft Registration Statement on Form F-1 Cover Page 1. We note your revised cover page graphic. Please further revise to reflect your disclosure elsewhere in the prospectus that the Phase 2 NS002 study was not powered for statistical significance. Business Research and Development, page 106 2. We note your response to prior comment 2 and reissue the comment as we do not see the revised disclosure. Please revise your pipeline table on page 107 to add separate May 7, 2025 Page 2 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. 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>
2025-04-22 - UPLOAD - Nasus Pharma Ltd File: 377-07416
<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>
2025-03-28 - UPLOAD - Nasus Pharma Ltd File: 377-07416
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 28, 2025 Udi Gilboa Executive Chairman Nasus Pharma Ltd. Yigal Alon 65 Tel Aviv, Israel 6744317 Re: Nasus Pharma Ltd. Amendment No. 3 to Draft Registration Statement on Form F-1 Submitted March 21, 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 February 18, 2025 letter. Amendment No. 3 to Draft Registration Statement on Form F-1 Cover Page 1. We note your graphic appearing after the prospectus cover page. Please remove the pipeline table portion of this graphic and revise the graphic to disclose that you are a development stage company and none of your product candidates have been approved by the Food and Drug Administration. You may present your pipeline table in the Prospectus Summary and/or Business sections, as appropriate. 2. We note your pipeline table in the cover art graphic disclosing your NS-003, NS-004 and NS-005 programs. Please revise your Prospectus Summary and Business section as appropriate to disclose the molecule for each drug candidate and the data March 28, 2025 Page 2 produced to date that supports including these programs in your pipeline table as material drug candidates. Alternatively, revise to remove these programs from your pipeline table. Management's Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources Current Outlook, page 73 3. We note your revised disclosure here that you "may sell fewer than all of the securities offered hereby" appears to conflict with the disclosure on your cover page and elsewhere in your prospectus that you are offering your securities on a firm- commitment basis. Please revise or otherwise advise. Business Nasus's Well Differentiated and Diversified Technology Platform - Intranasal Powder, page 86 4. Please revise your disclosure on page 87 to disclose whether you produced the nasal spray used in the Nasal Cast model. To the extent you did not produce the spray, please revise to disclose why it is appropriate to disclose the results of this laboratory model since it does not present the distribution of your powder sprays or remove the disclosure. Competitors and Market for NS002, page 102 5. To the extent your comparison of your product candidate to competitors in the graphic at the bottom of page 102 is not based on head-to-head clinical trials, please remove this graphic. Please also remove any similar graphics or claims that state or imply that your products are superior to competitor approved products that are not based on head-to-head clinical trials. Exhibits 6. We note your removal of the Master Services Agreement with Aptar France SAS from your exhibit index along with the related schedules of work. Please tell us why these agreements are not material contracts pursuant to Item 601(b)(10) of Regulation S-K. 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>
2025-02-18 - UPLOAD - Nasus Pharma Ltd File: 377-07416
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.
2025-01-28 - UPLOAD - Nasus Pharma Ltd File: 377-07416
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.
2024-09-27 - UPLOAD - Nasus Pharma Ltd File: 377-07416
September 27, 2024
Udi Gilboa
Executive Chairman
Nasus Pharma, Ltd.
Igal Alon 65
Tel Aviv, Israel 6744317
Re:Nasus Pharma, Ltd.
Draft Registration Statement on Form F-1
Submitted August 30, 2024
CIK No. 0002029039
Dear Udi Gilboa:
We have reviewed your 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.
Draft Registration Statement on Form F-1
Prospectus Summary
Our Company, page 1
1.With reference to your disclosures on page 105 and elsewhere, please revise your
Prospectus Summary to disclose that you plan to pursue FDA’s 505(b)(2) regulatory
pathway for NS001 and NS002. Briefly describe what that pathway entails and identify
the reference listed drug/device that you intend to use in your prospective NDA
applications. Identify and briefly explain the clinical testing that you plan to conduct prior
to submitting NDAs for both candidates. Briefly explain relevant terminology at first use,
including, as applicable, “reliability study,” “stability program,” “phase 2 study” and
“pivotal study.”
Please revise your Our Company section to provide a balanced presentation of your
business. In this regard, we note several performance claims concerning your product
candidates relative to approved products notwithstanding that you need to perform 2.
September 27, 2024
Page 2
additional clinical testing. With reference to your disclosures on pages 16, 21 and
elsewhere, please explain that you currently have no FDA approved products, that your
products have been tested on relatively small patient populations and the FDA may not
agree that your product candidates satisfy the requirements for the Section 505(b)(2)
regulatory approval.
3.Please revise your Prospectus to remove statements that your product candidates are safe
as safety determinations are within the sole discretion of the FDA and similar foreign
regulators. As a non-exhaustive list, we note your disclosure on page 1 that NS001 has a
“favorable safety profile,” on page 90 that “NS002 was found to be a safe, needle-free
treatment” and on page 93 that your pharmacodynamic results “reflect the safety of [y]our
intranasal administration.”
The Offering, page 5
4.Please revise here and in your Use of Proceeds section to clarify the stages of
development you intend to fund using the proceeds from this offering used for the “two
additional early-stage indications.”
Risk Factors
Risks Related to Our Business and Industry
We manage our business through a small number of employees and key consultants . . . ., page 44
5.Please revise to identify your one-full time employee. With reference to your
“Management” disclosure on page 123, please clarify which members of the management
team are part-time, independent contractors and/or consultants. To the extent that you do
not have a Chief Financial Officer or a full-time Chief Financial Officer, please revise to
provide appropriate risk factor disclosure or advise.
Business
The Intranasal Drug Delivery Product Market
Overview, page 79
6.We note your graphics on page 82 appear to have footnotes associated with different
countries but there are no accompanying footnote disclosures. We also note “USA” is
listed twice in both graphics. Please revise or otherwise advise.
Nasus's Well Differentiated and Diversified Technology Platform - Intranasal Powder, page 87
7.We refer to Figure 5 on page 88. Please identify the third-party particles depicted in the
left graphic and the particles depicted in the right graphic.
September 27, 2024
Page 3
Aptar UDS and collaboration, page 89
8.Please revise to explain whether the agreement covers use of the Unit Dose Spray product
to deliver drug products in addition to Naloxone. In this regard, it is unclear whether your
NS002 candidate will be delivered using Aptar’s nasal unidose system or another spray
system that is covered under a separate agreement.
Our Products, page 89
9.Please revise the Business section to disclose, for each clinical trial, the primary and
secondary endpoints, as applicable, whether the trials met these endpoints, whether the
trials were powered for statistical significance and if so, whether the results were
statistically significant, disclose if there were any significant adverse events and if so,
disclose the type and number of each. Regarding statistical significance, we note you
indicate some of your data is statistically significant, but we are unable to tell if the data
pertains to an endpoint and if so, whether the endpoint is a primary or secondary
endpoint.
Our phase 2 dose-finding/safety study - NP006, page 91
10.We note the reference on page 92 to a “PS002 study.” Please tell us whether this is the
same study as the NP006 study or is an entirely different one.
Intranasal Naloxone (NS001), page 94
11.Please revise your disclosure on page 98 to provide the details of the “scientific advice
request from several countries in the European Union.” Revise to state the purpose of the
“short preclinical study in rats.”
Competitors and Market for NS002, page 100
12.Please revise under this heading and elsewhere in your Business section to remove
statements that your products are superior to competitors and comparisons that were not
the result of head-to-head clinical trials. You may provide and discuss the data from head-
to-head clinical trials and state the conclusions supported by the data. Where you make
comparisons between your product candidates and approved therapies, revise to add
context that your product candidates have only been tested in small patient sample sizes,
have not been approved by the FDA or a similar foreign regulator and may never receive
such approval.
Intellectual Property, page 102
13.Please revise under this heading to disclose whether you own or license your intellectual
property, the expiration dates for your issued patents and expected expiration dates for
your pending patents. To the extent your intellectual property is licensed, revise your Risk
Factors section to provide appropriate disclosure.
Research and Development, page 105
We note your disclosures concerning the steps that you must complete in order to submit
the NDA dossier necessary for marketing approval of each product candidate. Please
expand your disclosure in this section or elsewhere in the Business section to explain what
each step entails. For steps that involve clinical testing, please explain the trial size, 14.
September 27, 2024
Page 4
timing, cost and the endpoints or performance measures that will need to be shown
relative to the reference drug/device product in order to support an NDA application filed
pursuant to the 505(b)(2) pathway.
15.For your NS002 candidate, please tell us whether you will need to conduct clinical testing
that involves self-administration by subjects with severe Type I allergies and patients
experiencing anaphylaxis. With respect to NS001, please tell us whether you will need to
conduct clinical testing for emergency treatment of known or suspected opioid overdose
or whether testing will be limited to healthy patients.
16.We note your disclosure on page 106 that you “entered into a non-recurring research and
development arrangement with a governmental body.” Please revise to state whether you
are still performing services pursuant to the agreement and whether the agreement
includes future obligations, and if so, disclose the obligations.
Orange Book Listing, page 108
17.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.
Exclusivity, page 109
18.Please revise to indicate, if known, whether you will pursue non-patent regulatory
exclusivity for your candidates. If you do not and/or there is a material risk that you will
not be eligible, please add a risk factor, as applicable, that you may face competition from
third parties seeking to market generic versions of your products shortly after FDA
approval.
Management
Compensation
Services Agreements with Executive Officers, page 125
19.Please revise under this heading where appropriate to disclose the exercise price and
expiration dates for the share options granted to Tair Lapidot and Oren Elmaliah under the
2019 Plan. Refer to Item 6.B(1) of Form 20-F.
Related Party Transactions
Formulex License Agreement, page 147
20.Please revise page 148 to disclose how Formulex may terminate the Formulex License
Agreement.
Financial Statements
Consolidated Statement of Operations, page F-4
21.Please revise your filing to present the subtotals and totals, such as those for operating
loss from continuing operations, net loss, and earnings per share information within
parentheses to represent that these are negative numbers.
September 27, 2024
Page 5
Signatures, page II-6
22.Please identify your principal executive officer or officers as well as your principal
financial officer, controller or principal accounting officer.
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 Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Eric Victorson, Esq.