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Pulmatrix, Inc.
Response Received
3 company response(s)
High - file number match
↓
Company responded
2025-04-17
Pulmatrix, Inc.
References: March 14, 2025
Summary
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Pulmatrix, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-05-23
Pulmatrix, Inc.
Summary
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Company responded
2024-05-28
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-06-07
Pulmatrix, Inc.
Summary
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Company responded
2021-06-07
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-08-11
Pulmatrix, Inc.
Summary
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Company responded
2020-08-11
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-07-01
Pulmatrix, Inc.
Summary
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Company responded
2020-07-01
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-04-08
Pulmatrix, Inc.
Summary
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Company responded
2019-04-08
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-03-25
Pulmatrix, Inc.
Summary
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Company responded
2019-04-02
Pulmatrix, Inc.
Summary
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Company responded
2019-04-02
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-03-14
Pulmatrix, Inc.
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Company responded
2019-03-14
Pulmatrix, Inc.
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Pulmatrix, Inc.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2018-03-19
Pulmatrix, Inc.
Summary
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Company responded
2018-03-26
Pulmatrix, Inc.
Summary
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Company responded
2018-03-26
Pulmatrix, Inc.
Summary
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Company responded
2018-03-27
Pulmatrix, Inc.
Summary
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Company responded
2018-03-28
Pulmatrix, Inc.
Summary
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Company responded
2018-03-28
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-10-21
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2016-09-29
Pulmatrix, Inc.
Summary
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Company responded
2016-10-11
Pulmatrix, Inc.
References: September 28, 2016
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Pulmatrix, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2016-07-25
Pulmatrix, Inc.
Summary
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Company responded
2016-07-29
Pulmatrix, Inc.
References: July 25, 2016
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Company responded
2016-08-01
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2014-03-06
Pulmatrix, Inc.
Summary
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Company responded
2014-03-10
Pulmatrix, Inc.
References: March 6, 2014
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Company responded
2014-03-14
Pulmatrix, Inc.
Summary
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Company responded
2014-03-20
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2013-11-18
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2013-11-18
Pulmatrix, Inc.
Summary
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Pulmatrix, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2013-08-23
Pulmatrix, Inc.
Summary
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Company responded
2013-10-15
Pulmatrix, Inc.
References: August 23, 2013 | August 8, 2013 | June 21, 2013
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Pulmatrix, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2013-06-24
Pulmatrix, Inc.
Summary
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Company responded
2013-08-08
Pulmatrix, Inc.
References: June 21, 2013
Summary
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-08 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2025-05-07 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2025-04-17 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2025-03-17 | SEC Comment Letter | Pulmatrix, Inc. | DE | 333-284993 | Read Filing View |
| 2024-05-28 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2024-05-23 | SEC Comment Letter | Pulmatrix, Inc. | DE | 333-279491 | Read Filing View |
| 2021-06-07 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2021-06-07 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2020-08-11 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2020-08-11 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2020-07-01 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2020-07-01 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-04-08 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-04-08 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-04-02 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-04-02 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-03-25 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-03-14 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-03-14 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-28 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-28 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-27 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-26 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-26 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-19 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-10-21 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-10-11 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-09-29 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-08-01 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-07-29 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-07-25 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2014-03-20 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2014-03-14 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2014-03-10 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2014-03-06 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-11-18 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-11-18 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-10-15 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-08-23 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-08-08 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-06-24 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-17 | SEC Comment Letter | Pulmatrix, Inc. | DE | 333-284993 | Read Filing View |
| 2024-05-23 | SEC Comment Letter | Pulmatrix, Inc. | DE | 333-279491 | Read Filing View |
| 2021-06-07 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2020-08-11 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2020-07-01 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-04-08 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-03-25 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-03-14 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-19 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-10-21 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-09-29 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-07-25 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2014-03-06 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-08-23 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-06-24 | SEC Comment Letter | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-08 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2025-05-07 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2025-04-17 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2024-05-28 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2021-06-07 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2020-08-11 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2020-07-01 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-04-08 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-04-02 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-04-02 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2019-03-14 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-28 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-28 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-27 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-26 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2018-03-26 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-10-11 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-08-01 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2016-07-29 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2014-03-20 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2014-03-14 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2014-03-10 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-11-18 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-11-18 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-10-15 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
| 2013-08-08 | Company Response | Pulmatrix, Inc. | DE | N/A | Read Filing View |
2025-05-08 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm May 8, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attn: Christine Torney Daniel Gordon Tyler Howes Joe McCann Re: Pulmatrix, Inc. Registration Statement on Form S-4, as amended Filed on February 14, 2025, as amended on April 17, 2025, and May 7, 2025 File No. 333-284993 Ladies and Gentlemen: This letter is submitted on behalf of Pulmatrix, Inc. (the " Company ") in response to an oral comment from the staff (the " Staff ") of the Securities and Exchange Commission (the " Commission ") received by telephone on May 8, 2025, relating to the above referenced Registration Statement on Form S-4 filed with the Commission on February 14, 2025, as amended on April 17, 2025, and May 7, 2025 (as amended, the " Registration Statement ") and the request that the Company confirms in writing that the Company will notify the Commission promptly of any changes to its disclosure regarding, or requested by, the CSRC. Terms that are not otherwise defined have the meanings ascribed to them in the Registration Statement. The Company respectfully acknowledges the Staff's oral comment and advises the Staff that the Company intends to notify the Staff of any changes to its disclosure in the Registration Statement regarding, or requested by, the CSRC after the date hereof and prior to the closing of the merger. Further, upon receipt of the requisite CSRC approval required to consummate the merger, the Company will notify its stockholders by filing a Current Report on Form 8-K. Should the Staff have any questions concerning the enclosed matters, please contact the undersigned at 212-659-4974. Very truly yours, /s/ Rick A. Werner Rick A. Werner, Esq. cc: Peter Ludlum, Pulmatrix, Inc. Alla Digilova, Esq., Haynes and Boone, LLP Ryan Murr, Esq., Gibson, Dunn & Crutcher LLP Branden Berns, Esq., Gibson, Dunn & Crutcher LLP Melanie Neary, Esq., Gibson, Dunn & Crutcher LLP
2025-05-07 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm Pulmatrix, Inc. 945 Concord Street, Suite 1217 Framingham, MA 01701 May 7, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Securities and Exchange Commission Washington, D.C. 20549 Attention: Tyler Howes Re: Pulmatrix, Inc. Registration Statement on Form S-4, as amended Filed on February 14, 2025, as amended on April 17, 2025, and May 7, 2025 File No. 333-284993 (as amended, the " Registration Statement ") Request for Acceleration Dear Mr. Howes, Pursuant to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the " Commission ") under the Securities Act of 1933, as amended, Pulmatrix, Inc. (the " Company ") hereby respectfully requests acceleration of the effective date of the Registration Statement, so that it may become effective at 4:30 p.m., Eastern Time, on May 9, 2025, or as soon thereafter as practicable. The Company hereby authorizes each of Rick A. Werner and Alla Digilova of Haynes and Boone, LLP, counsel to the Company, to make such request on its behalf. Once the Registration Statement is effective, please orally confirm the event with the Company's counsel, Haynes and Boone, LLP by calling Rick A. Werner at (212) 659-4974. The Company also respectfully requests that a copy of the written order from the Commission verifying the effective time and date of the Registration Statement be sent to the Company's counsel, Haynes and Boone, LLP, Attention: Rick A. Werner, by email to rick.werner@haynesboone.com. Should any member of the staff of the Commission have any questions or comments with respect to this request, please contact our counsel, Haynes and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974. Very truly yours, PULMATRIX, INC. By: /s/ Peter Ludlum Peter Ludlum Interim Chief Executive Officer cc: Rick A. Werner, Esq., Haynes and Boone, LLP Alla Digilova, Esq., Haynes and Boone, LLP Ryan A. Murr, Gibson, Dunn & Crutcher LLP Branden C. Berns, Gibson, Dunn & Crutcher LLP Melanie E. Neary, Gibson, Dunn & Crutcher LLP
2025-04-17 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
April
17, 2025
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F. Street, N.E.
Washington,
D.C. 20549
Attn:
Christine
Torney
Daniel
Gordon
Tyler
Howes
Joe
McCann
Re:
Pulmatrix,
Inc.
Registration
Statement on Form S-4
Filed
on February 14, 2025
File
No. 333-284993
Ladies
and Gentlemen:
This
letter is submitted on behalf of Pulmatrix, Inc. (the " Company ") in response to comments from the staff (the " Staff ")
of the Securities and Exchange Commission (the " Commission ") contained in the letter dated March 14, 2025 (the " Comment
Letter ") regarding the Company's Registration Statement on Form S-4 filed with the Commission on February 14, 2025 (the
" Registration Statement "). In connection with this response to the Comment Letter, the Company is contemporaneously
filing via EDGAR Amendment No. 1 to the Registration Statement (" Amendment No. 1 "), which has been amended in response
to the Staff's comments in the Comment Letter.
The
following are the Company's responses to the Comment Letter. For your convenience, the Staff's comments contained in the
Comment Letter have been restated below in their entirety in italic type, with the Company's corresponding responses set forth
immediately under such comments, including, where applicable, a cross-reference to the location of changes made in Amendment No. 1 in
response to the Staff's comments. All page references in the responses set forth below refer to page numbers in Amendment No. 1
as filed conterminously here with. Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in Amendment
No. 1.
Registration
Statement on Form S-4 filed February 14, 2025
Cover
Page
1. Please
disclose prominently on the prospectus cover page that Cullgen is a Delaware company with
significant operations conducted in China through the company's Shanghai subsidiary.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised its disclosure to disclose that
Cullgen is a Delaware company with significant operations conducted in China through Cullgen Shanghai. Please see the cover page and
page 14 of Amendment No. 1.
2. Provide
prominent disclosure about the legal and operational risks associated with being based in
or having the majority of the combined company's operations in China. Your disclosure
should make clear whether these risks could result in a material change in your operations
and/or the value of the securities you are registering for sale or could significantly limit
or completely hinder your ability to offer or continue to offer securities to investors and
cause the value of such securities to significantly decline or be worthless. Your disclosure
should address how recent statements and regulatory actions by China's government,
such as those related to data security or anti-monopoly concerns, have or may impact the
company's ability to conduct its business, accept foreign investments, or list on a
U.S. or other foreign exchange. Please disclose whether Ernst & Young Hua Ming LLP is
subject to the determinations announced by the PCAOB on December 16, 2021 and whether and
how the Holding Foreign Companies Accountable Act and related regulations will affect your
company. Your Q&A and/or prospectus summary should address, but not necessarily be limited
to, the risks highlighted on the prospectus cover page.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised its disclosure to include legal
and operational risks associated with having a majority of the Combined Company's operations in China. Please see the cover page
and pages 14-16 and 84 of Amendment No. 1.
3. Provide
a description of how cash will be transferred through the combined company's organization
and disclose your intentions to distribute earnings. State whether any transfers, dividends,
or distributions have been made to date between Cullgen and its subsidiary, or to investors,
and quantify the amounts where applicable. Provide cross references to the condensed consolidating
schedule and the consolidated financial statements.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised its disclosure to provide a description
of how cash will be transferred through the Combined Company's organization and its expectations regarding the distribution of
earnings. Please see the cover page and pages 15 and 269-270 of Amendment No. 1.
Questions
and Answers about the Merger, page 1
4. Please
revise the Q&A to explain whether Pulmatrix's board would be authorized to implement
a reverse stock split and/or an increase to authorized common shares if Proposals 2 and 3
were to pass but Proposal 1 were not to receive stockholder approval.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised its disclosure to explain whether
Pulmatrix's board would be authorized to implement a reverse stock split and/or an increase to authorized common shares if Proposals
2 and 3 were to pass but Proposal 1 were not to receive stockholder approval. Please see pages 4, 186 and 189 of Amendment
No. 1.
5. We
note the disclosure on pages 107 and 319 indicating that Cullgen currently is a subsidiary
of GNI Japan. Please add a Q&A to discuss the past, current and future relationship between
Cullgen and GNI. For instance, tell us and disclose, as applicable, whether GNI founded Cullgen.
Discuss whether GNI and Cullgen's current parent/subsidiary relationship is planned
to change as a result of the reverse merger transaction. In light of GNI's significant
equity interest in Cullgen and the overlap in their management teams, please discuss whether
GNI will control Cullgen's operations. Discuss any material contracts between the parties
that will survive the merger, including any arrangements involving funding, tax allocation,
technology transfer or provision of services, as applicable.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has added the requested Q&A to discuss
the past, current and future relationship between Cullgen, GNI Japan and the Combined Company. Please see page 7 of Amendment
No. 1.
6. Please
add a Q&A that discusses Pulmatrix's current plans to sell its historical assets
and operations. Discuss risks to Pulmatrix shareholders stemming from uncertainties surrounding
these potential sales, including without limitation the potential impact on whether a special
dividend is paid and the amount of any such dividend.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has added a Q&A that discusses Pulmatrix's
current plans to sell its historical assets and operations. Such Q&A discusses risks to Pulmatrix shareholders stemming from uncertainties
surrounding these potential sales, including without limitation the potential impact on whether a special dividend is paid and the amount
of any such dividend. Please see page 3 of Amendment No. 1.
Q:
What will Pulmatrix securityholders receive in the Merger?, page 2
7. We
note your disclosure here and elsewhere indicating that the Pulmatrix board of directors
may declare a pre-closing Special Cash Dividend. Please explain whether Pulmatrix shareholders
will know prior to commencement of voting whether the Pulmatrix board is committed to issuing
a dividend within the parameters negotiated by the Merger parties.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised its disclosure to indicate that
the Pulmatrix stockholders will not know prior to commencement of voting whether the Pulmatrix board is committed to issuing a dividend
within the paraments negotiated by the Merger parties. Please see pages 2 and 155 of Amendment No. 1.
Prospectus
Summary
The
Companies, page 12
8. We
note your statement claiming that Cullgen's product candidates have distinct advantages
including "improved efficacy" over other therapeutic modalities. Given that Cullgen
is early in its development efforts, please revise this statement, and any others like it,
to avoid the implication that Cullgen's product candidates are or will be deemed effective,
as such conclusions are within the sole authority of FDA and comparable foreign regulators.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised its disclosure to remove claims
that Cullgen's product candidates have "improved efficacy" over other therapeutic modalities. Please see pages 13,
220 and 281 of Amendment No. 1.
9. Please
provide a diagram of Cullgen's corporate structure, identifying the person or entity
that owns the equity in each depicted entity.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has provided a diagram of Cullgen's corporate
structure. Please see page 25 of Amendment No. 1.
10. Disclose
each permission or approval that Cullgen and its subsidiaries are required to obtain from
Chinese authorities to operate their business and to offer the securities being registered
to foreign investors. State whether Cullgen is covered by permissions requirements from the
China Securities Regulatory Commission (CSRC), Cyberspace Administration of China (CAC) or
any other governmental agency and state affirmatively whether they have received all requisite
permissions or approvals and whether any permissions or approvals have been denied. Please
also describe the consequences to investors if they: (i) do not receive or maintain such
permissions or approvals, (ii) inadvertently conclude that such permissions or approvals
are not required, or (iii) applicable laws, regulations, or interpretations change and you
are required to obtain such permissions or approvals in the future.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised its disclosure to disclose each
permission or approval that Cullgen and Cullgen Shanghai are required to obtain from Chinese authorities to operate their business and
to offer the securities being registered to foreign investors. Please see pages 21-22 of Amendment No. 1.
11. Provide
a clear description of how cash will be transferred through the organization. Disclose your
intentions to distribute earnings. Quantify any cash flows and transfers of other assets
by type that have occurred between Cullgen and its subsidiaries, and direction of transfer.
Quantify any dividends or distributions that a subsidiary has made to the holding company
and which entity made such transfer, and their tax consequences. Similarly quantify dividends
or distributions made to U.S. investors, the source, and their tax consequences. Your disclosure
should make clear if no transfers, dividends, or distributions have been made to date. Describe
any restrictions on foreign exchange and your ability to transfer cash between entities,
across borders, and to U.S. investors. Describe any restrictions and limitations on your
ability to distribute earnings from the company, including your subsidiaries, to the parent
company and U.S. investors.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised its disclosure to provide a description
of how cash will be transferred through the Combined Company's organization and its expectations regarding the distribution of
earnings. Please see the cover page and pages 15 and 269-270 of Amendment No. 1.
12. Disclose
that trading in your securities may be prohibited under the Holding Foreign Companies Accountable
Act if the PCAOB determines that it cannot inspect or investigate completely your auditor,
and that as a result an exchange may determine to delist your securities. Disclose here whether
your auditor is subject to the determinations announced by the PCAOB on December 16, 2021.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised its disclosure to disclose that
the Combined Company securities may be prohibited under the Holding Foreign Companies Accountable Act if the PCAOB determines that it
cannot inspect or investigate completely the Combined Company's auditor. Please see the cover page and pages 15-16 of Amendment No. 1.
The
Merger
Background
of the Merger, page 101
13. Please
revise here to disclose the final valuation attributed to Cullgen in the merger agreement.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised the " The Merger-Background
of the Merger " section to disclose the final valuation attributed to Cullgen in the merger agreement. Please see pages 113-114
of Amendment No. 1.
14. Please
revise to provide a more fulsome discussion related to the changes in the valuation of Pulmatrix.
For example, we note that disclosure here indicates that Pulmatrix was initially valued at
$10 million by the parties on October 25, 2024, but disclosure on page 121 indicates that
the final merger agreement values Pulmatrix at $8 million. Please disclose the parties'
reasoning for such changes.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised the " The Merger-Background
of the Merger " section to provide a more fulsome discussion related to the changes in the valuation of Pulmatrix and the parties'
reasoning for such changes. Please see pages 113-114 and 132 of Amendment No. 1.
15. Please
revise to clarify whether Party C made an offer in the August 2024 to October 2024 timeframe
and when negotiations with Party C terminated.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised the " The Merger-Background
of the Merger " section to clarify whether Party C made an offer in the August 2024 to October 2024 timeframe and when negotiations
with Party C terminated. Please see pages 112-113 of Amendment No. 1.
16. We
note that Pulmatrix's board considered liquidation scenarios at multiple points during
2024. Please revise to disclose each of the relevant liquidation values assessed. Similarly
revise the disclosure on page 106 to identify the liquidation value that Pulmatrix's
board considered when rendering its decision at the November 11, 2024 meeting.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised the " The Merger-Background
of the Merger " section to disclose each of the relevant liquidation values assessed and has also revised the disclosure to
identify the liquidation value that the Pulmatrix board of directors considered when rendering its decision at the November 11, 2024
meeting. Please see pages 111-112 and 115 of Amendment No. 1.
Pulmatrix's
Reasons for the Merger, page 106
17. Please
revise the disclosure on page 107 to identify the large pharmaceutical partner and the applicable
research and development efforts.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised the disclosure in the " The
Merger-Pulmatrix's Reasons for the Merger " section to identify the large pharmaceutical partner and the applicable
research and development efforts. Please see page 115 of Amendment No. 1.
Cullgen's
Business, page 211
18. With
reference to the unaudited pro forma financials, please revise to disclose how the combined
company plans to allocate funding across the five clinical and preclinical programs identified
in the pipeline table on page 215.
The
Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised its disclosure to disclose how
the Combined Company plans to allocate funding across its clinical and preclinical
2025-03-17 - UPLOAD - Pulmatrix, Inc. File: 333-284993
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 14, 2025 Peter Ludlum Interim Chief Executive Officer Pulmatrix, Inc. 945 Concord Street, Suite 1217 Framingham, MA 01701 Re: Pulmatrix, Inc. Registration Statement on Form S-4 Filed February 14, 2025 File No. 333-284993 Dear Peter Ludlum: We have reviewed your 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. Registration Statement on Form S-4 Cover Page 1. Please disclose prominently on the prospectus cover page that Cullgen is a Delaware company with significant operations conducted in China through the company's Shanghai subsidiary. 2. Provide prominent disclosure about the legal and operational risks associated with being based in or having the majority of the combined company's operations in China. Your disclosure should make clear whether these risks could result in a material change in your operations and/or the value of the securities you are registering for sale or could significantly limit or completely hinder your ability to offer or continue to offer securities to investors and cause the value of such securities to significantly decline or be worthless. Your disclosure should address how recent statements and regulatory actions by China s government, such as those related to data security or anti-monopoly concerns, have or may impact the company s ability to conduct its March 14, 2025 Page 2 business, accept foreign investments, or list on a U.S. or other foreign exchange. Please disclose whether Ernst & Young Hua Ming LLP is subject to the determinations announced by the PCAOB on December 16, 2021 and whether and how the Holding Foreign Companies Accountable Act and related regulations will affect your company. Your Q&A and/or prospectus summary should address, but not necessarily be limited to, the risks highlighted on the prospectus cover page. 3. Provide a description of how cash will be transferred through the combined company's organization and disclose your intentions to distribute earnings. State whether any transfers, dividends, or distributions have been made to date between Cullgen and its subsidiary, or to investors, and quantify the amounts where applicable. Provide cross- references to the condensed consolidating schedule and the consolidated financial statements. Questions and Answers about the Merger, page 1 4. Please revise the Q&A to explain whether Pulmatrix's board would be authorized to implement a reverse stock split and/or an increase to authorized common shares if Proposals 2 and 3 were to pass but Proposal 1 were not to receive stockholder approval. 5. We note the disclosure on pages 107 and 319 indicating that Cullgen currently is a subsidiary of GNI Japan. Please add a Q&A to discuss the past, current and future relationship between Cullgen and GNI. For instance, tell us and disclose, as applicable, whether GNI founded Cullgen. Discuss whether GNI and Cullgen's current parent/subsidiary relationship is planned to change as a result of the reverse merger transaction. In light of GNI's significant equity interest in Cullgen and the overlap in their management teams, please discuss whether GNI will control Cullgen's operations. Discuss any material contracts between the parties that will survive the merger, including any arrangements involving funding, tax allocation, technology transfer or provision of services, as applicable. 6. Please add a Q&A that discusses Pulmatrix's current plans to sell its historical assets and operations. Discuss risks to Pulmatrix shareholders stemming from uncertainties surrounding these potential sales, including without limitation the potential impact on whether a special dividend is paid and the amount of any such dividend. Q: What will Pulmatrix securityholders receive in the Merger?, page 2 7. We note your disclosure here and elsewhere indicating that the Pulmatrix board of directors may declare a pre-closing Special Cash Dividend. Please explain whether Pulmatrix shareholders will know prior to commencement of voting whether the Pulmatrix board is committed to issuing a dividend within the parameters negotiated by the Merger parties. Prospectus Summary The Companies, page 12 8. We note your statement claiming that Cullgen's product candidates have distinct advantages including "improved efficacy" over other therapeutic modalities. Given that Cullgen is early in its development efforts, please revise this statement, and any March 14, 2025 Page 3 others like it, to avoid the implication that Cullgen's product candidates are or will be deemed effective, as such conclusions are within the sole authority of FDA and comparable foreign regulators. 9. Please provide a diagram of Cullgen s corporate structure, identifying the person or entity that owns the equity in each depicted entity. 10. Disclose each permission or approval that Cullgen and its subsidiaries are required to obtain from Chinese authorities to operate their business and to offer the securities being registered to foreign investors. State whether Cullgen is covered by permissions requirements from the China Securities Regulatory Commission (CSRC), Cyberspace Administration of China (CAC) or any other governmental agency and state affirmatively whether they have received all requisite permissions or approvals and whether any permissions or approvals have been denied. Please also describe the consequences to investors if they: (i) do not receive or maintain such permissions or approvals, (ii) inadvertently conclude that such permissions or approvals are not required, or (iii) applicable laws, regulations, or interpretations change and you are required to obtain such permissions or approvals in the future. 11. Provide a clear description of how cash will be transferred through the organization. Disclose your intentions to distribute earnings. Quantify any cash flows and transfers of other assets by type that have occurred between Cullgen and its subsidiaries, and direction of transfer. Quantify any dividends or distributions that a subsidiary has made to the holding company and which entity made such transfer, and their tax consequences. Similarly quantify dividends or distributions made to U.S. investors, the source, and their tax consequences. Your disclosure should make clear if no transfers, dividends, or distributions have been made to date. Describe any restrictions on foreign exchange and your ability to transfer cash between entities, across borders, and to U.S. investors. Describe any restrictions and limitations on your ability to distribute earnings from the company, including your subsidiaries, to the parent company and U.S. investors. 12. Disclose that trading in your securities may be prohibited under the Holding Foreign Companies Accountable Act if the PCAOB determines that it cannot inspect or investigate completely your auditor, and that as a result an exchange may determine to delist your securities. Disclose here whether your auditor is subject to the determinations announced by the PCAOB on December 16, 2021. The Merger Background of the Merger, page 101 13. Please revise here to disclose the final valuation attributed to Cullgen in the merger agreement. 14. Please revise to provide a more fulsome discussion related to the changes in the valuation of Pulmatrix. For example, we note that disclosure here indicates that Pulmatrix was initially valued at $10 million by the parties on October 25, 2024, but disclosure on page 121 indicates that the final merger agreement values Pulmatrix at $8 million. Please disclose the parties' reasoning for such changes. 15. Please revise to clarify whether Party C made an offer in the August 2024 to October March 14, 2025 Page 4 2024 timeframe and when negotiations with Party C terminated. 16. We note that Pulmatrix's board considered liquidation scenarios at multiple points during 2024. Please revise to disclose each of the relevant liquidation values assessed. Similarly revise the disclosure on page 106 to identify the liquidation value that Pulmatrix's board considered when rendering its decision at the November 11, 2024 meeting. Pulmatrix's Reasons for the Merger, page 106 17. Please revise the disclosure on page 107 to identify the large pharmaceutical partner and the applicable research and development efforts. Cullgen's Business, page 211 18. With reference to the unaudited pro forma financials, please revise to disclose how the combined company plans to allocate funding across the five clinical and preclinical programs identified in the pipeline table on page 215. Cullgen's Strengths, page 212 19. We note your statements claiming CG001419 is being developed as a "potential first- in-class" treatment for both pain management and certain cancers. Please revise these statements as they appear to be speculative given the current development status of these product candidates and the noted length and uncertainty of the drug approval processes. Cullgen's Strategy, page 213 20. Please revise your disclosures on page 213 to explain the terms "clinically validated" and "clinically relevant." Clinical and Preclinical Pipeline, page 215 21. Please revise your pipeline table to include a column for Phase 3 to clearly represent all development stages that must be completed prior to submission of your product candidates for regulatory approval. 22. We note the inclusion of two "undisclosed" preclinical programs in your pipeline table. Please tell us what aspects of the programs are undisclosed. Please note that we may have additional comment regarding inclusion of these candidates in your pipeline table. Phase 1/2 clinical trial, page 220 23. Please revise to identify the treatment emergent adverse event that led to drug discontinuation. Phase 1 clinical trial, page 230 24. Please revise to briefly discuss the material aspects of Cullgen's planned Phase 1 trial of CG009301 in patients with refractory hematologic malignancies including the expected number of patients you will enroll, the location of the trial and planned clinical endpoints. March 14, 2025 Page 5 Patents, page 235 25. We note your disclosure regarding the patent and patent applications that Cullgen or its affiliates own. Please revise to identify these affiliates to clarify if you are referring to Cullgen Shanghai, GNI Japan or other entities. Unaudited Pro Forma Condensed Combined Financial Information Notes to Unaudited Pro Forma Condensed Combined Financial Statements 3. Adjustments to the Unaudited Pro Forma Condensed Combined Statement of Operations for the Nine Months Ended September 30, 2024 and for the Year Ended December 31, 2023, page 299 26. Please explain why the estimated transaction costs of $7.9 million, as reflected in Adjustment B, which are not yet reflected in the historical financial statements as of September 30, 2024, and are expected to be incurred by Cullgen in connection with the merger, are not included as an adjustment in the December 31, 2023, Unaudited Pro Forma Condensed Combined Statement of Operations. 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. 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 Tyler Howes at 202-551-3370 or Joe McCann at 202-551-6262 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Alok Choksi, Esq. </TEXT> </DOCUMENT>
2024-05-28 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
Pulmatrix,
Inc.
36
Crosby Drive, Suite 100
Bedford,
MA 01730
May
28, 2024
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
Washington,
D.C. 20549
Attention:
Jimmy McNamara
Re:
Pulmatrix,
Inc.
Registration
Statement on Form S-3
Filed
on May 17, 2024
File
No. 333-279491 (the “Registration Statement”)
Request
for Acceleration
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”) under
the Securities Act of 1933, as amended, Pulmatrix, Inc. (the “Company”) hereby respectfully requests acceleration
of the effective date of the Registration Statement so that it may become effective at 4:30 p.m., Eastern Time, on May 30, 2024,
or as soon thereafter as practicable.
Should
any member of the staff of the Commission have any questions or comments with respect to this request, please contact our counsel, Haynes
and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974.
Very
truly yours,
PULMATRIX,
INC.
By:
/s/
Teofilo Raad
Teofilo
Raad
Chief
Executive Officer and President
cc:
Rick A. Werner, Esq., Haynes and Boone, LLP
2024-05-23 - UPLOAD - Pulmatrix, Inc. File: 333-279491
United States securities and exchange commission logo
May 23, 2024
Teofilo Raad
Chief Executive Officer and President
Pulmatrix, Inc.
36 Crosby Drive, Suite 100
Bedford, MA 01730
Re:Pulmatrix, Inc.
Registration Statement on Form S-3
Filed May 17, 2024
File No. 333-279491
Dear Teofilo Raad:
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 Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Rick Werner
2021-06-07 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
Pulmatrix,
Inc.
99
Hayden Avenue, Suite 390
Lexington,
MA 02421
June
7, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Securities and Exchange Commission
Washington, D.C. 20549
Attention:
Tom Kluck
Re: Pulmatrix,
Inc.
Registration Statement on Form S-3
Filed
on May 26, 2021
File
No. 333-256502 (the “Registration Statement”)
Request
for Acceleration
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”)
under the Securities Act of 1933, as amended, Pulmatrix, Inc. (the “Company”) hereby respectfully requests
acceleration of the effective date of the Registration Statement so that it may become effective at 5:00 p.m., Eastern Time, on
June 9, 2021, or as soon thereafter as practicable.
Should
any member of the staff of the Commission have any questions or comments with respect to this request, please contact our counsel,
Haynes and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974.
Very truly yours,
PULMATRIX, INC.
By:
/s/ Teofilo Raad
Teofilo Raad
Chief Executive Officer and President
cc: Rick
A. Werner, Esq., Haynes and Boone, LLP
2021-06-07 - UPLOAD - Pulmatrix, Inc.
United States securities and exchange commission logo
June 7, 2021
Teofilo Raad
Chief Executive Officer and President
Pulmatrix, Inc.
99 Hayden Avenue, Suite 390
Lexington, MA 02421
Re:Pulmatrix, Inc.
Registration Statement on Form S-3
Filed May 26, 2021
File No. 333-256502
Dear Mr. Raad:
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 Tom Kluck at 202-551-3233 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Rick Werner
2020-08-11 - UPLOAD - Pulmatrix, Inc.
United States securities and exchange commission logo
August 11, 2020
Teofilo Raad
Chief Executive Officer
Pulmatrix, Inc.
99 Hayden Avenue, Suite 390
Lexington, Massachusetts 02421
Re:Pulmatrix, Inc.
Registration Statement on Form S-3
Filed August 7, 2020
File No. 333-242341
Dear Mr. Raad:
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 Courtney Lindsay at (202) 551-7237 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-08-11 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
Pulmatrix,
Inc.
99
Hayden Avenue, Suite 390
Lexington,
MA 02421
August
11, 2020
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Washington,
D.C. 20549
Attention:
Courtney Lindsay
Re:
Pulmatrix,
Inc.
Registration
Statement on Form S-3
Filed
on August 7, 2020
File
No. 333-242341 (the “Registration Statement”)
Request
for Acceleration
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”)
under the Securities Act of 1933, as amended, Pulmatrix, Inc. (the “Company”) hereby respectfully requests
acceleration of the effective date of the Registration Statement so that it may become effective at 5:00 p.m., Eastern Time, on
August 13, 2020, or as soon thereafter as practicable.
Should
any member of the staff of the Commission have any questions or comments with respect to this request, please contact our counsel,
Haynes and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974.
Very
truly yours,
PULMATRIX,
INC.
By:
/s/
Teofilo Raad
Teofilo
Raad
Chief
Executive Officer and President
cc:
Rick
A. Werner, Esq., Haynes and Boone, LLP
Matthew
L. Fry, Esq., Haynes and Boone, LLP
2020-07-01 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
Pulmatrix,
Inc.
99
Hayden Avenue, Suite 390
Lexington,
MA 02421
July
1, 2020
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Securities and Exchange Commission
Washington, D.C. 20549
Attention:
Alan Campbell
Re:
Pulmatrix,
Inc.
Registration
Statement on Form S-1
Filed
on June 25, 2020
File
No. 333-239431 (the “Registration Statement”)
Request
for Acceleration
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”)
under the Securities Act of 1933, as amended, Pulmatrix, Inc. (the “Company”) hereby respectfully requests
acceleration of the effective date of the Registration Statement so that it may become effective at 5:00 p.m., Eastern Time, on
July 2, 2020, or as soon thereafter as practicable.
Should
any member of the staff of the Commission have any questions or comments with respect to this request, please contact our counsel,
Haynes and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974.
Very
truly yours,
PULMATRIX,
INC.
By:
/s/
Teofilo Raad
Teofilo
Raad
Chief Executive Officer and President
cc:
Rick
A. Werner, Esq., Haynes and Boone, LLP
2020-07-01 - UPLOAD - Pulmatrix, Inc.
United States securities and exchange commission logo
June 30, 2020
Teofilo Raad
Chief Executive Officer and President
Pulmatrix, Inc.
99 Hayden Avenue, Suite 390
Lexington, MA 02421
Re:Pulmatrix, Inc.
Registration Statement on Form S-1
Filed June 25, 2020
File No. 333-239431
Dear Mr. Raad:
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 Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Rick A. Werner, Esq.
2019-04-08 - UPLOAD - Pulmatrix, Inc.
April 5, 2019
Robert W. Clarke
Chief Executive Officer
Pulmatrix, Inc.
99 Hayden Avenue, Suite 390
Lexington, MA 02421
Re:Pulmatrix, Inc.
Registration Statement on Form S-1
Filed April 1, 2019
File No. 333-230670
Dear Dr. Clarke:
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 Donald Field at 202-551-3680 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-04-08 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm Acceleration Request Pulmatrix, Inc. 99 Hayden Avenue, Suite 390 Lexington, MA 02421 April 8, 2019 By EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Attention: Donald Field RE: Pulmatrix, Inc. Registration Statement on Form S-1 Filed April 1, 2019 Request for Acceleration File No. 333-230670 Ladies and Gentlemen: Pursuant to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended, Pulmatrix, Inc. (the “Company”) hereby requests acceleration of the effective date of the above-mentioned Registration Statement on Form S-1 (the “Registration Statement”) to 5:00 p.m., Eastern Time on April 10, 2019, or as soon thereafter as practicable. Should any member of the staff of the U.S. Securities and Exchange Commission have any questions or comments with respect to this request, please contact our counsel, Haynes and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974. Very truly yours, Pulmatrix, Inc. By: /s/ Robert W. Clarke Robert W. Clarke, Ph.D. Chief Executive Officer cc: Rick A. Werner, Esq., Haynes and Boone, LLP
2019-04-02 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm Underwriter Acceleration Request April 2, 2019 VIA FACSIMILE AND EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Washington, D.C. 20549 Re: PULMATRIX, INC. Registration Statement on Form S-1 (Registration No. 333-230395) Concurrence in Acceleration Request Ladies and Gentlemen: H.C. Wainwright & Co., LLC (“Wainwright”), as managing underwriter for the above-referenced offering, hereby concurs in the request by Pulmatrix, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:00 P.M. Eastern Time on Wednesday, April 3, 2019, or as soon as practicable thereafter, pursuant to Rule 461 under the Securities Act. Wainwright affirms that it is aware of its obligations under the Securities Act in connection with this offering. Very truly yours, H.C. WAINWRIGHT & CO., LLC By: /s/ Edward D. Silvera Name: Edward D. Silvera Title: Chief Operating Officer 430 Park Avenue | New York, New York 10022 | 212.356.0500 Security services provided by H.C. Wainwright & Co., LLC | Member: FINRA/SIPC
2019-04-02 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm Acceleration Request Pulmatrix, Inc. 99 Hayden Avenue, Suite 390 Lexington, MA 02421 April 2, 2019 By EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Attention: Donald Field RE: Pulmatrix, Inc. Registration Statement on Form S-1 Filed March 19, 2019, as amended April 1, 2019 Request for Acceleration File No. 333-230395 Ladies and Gentlemen: Pursuant to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended, Pulmatrix, Inc. (the “Company”) hereby requests acceleration of the effective date of the above-mentioned Registration Statement on Form S-1 (the “Registration Statement”) to 5:00 p.m., Eastern Time on April 3, 2019, or as soon thereafter as practicable. Should any member of the staff of the U.S. Securities and Exchange Commission have any questions or comments with respect to this request, please contact our counsel, Haynes and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974. Very truly yours, Pulmatrix, Inc. By: /s/ Robert W. Clarke Robert W. Clarke, Ph.D. Chief Financial Officer and President cc: Rick A. Werner, Esq., Haynes and Boone, LLP Michael Pritchard, Esq., Haynes and Boone, LLP
2019-03-25 - UPLOAD - Pulmatrix, Inc.
March 25, 2019
Robert W. Clarke
Chief Executive Officer
Pulmatrix, Inc.
99 Hayden Avenue, Suite 390
Lexington, MA 02421
Re:Pulmatrix, Inc.
Registration Statement on Form S-1
Filed March 19, 2019
File No. 333-230395
Dear Dr. Clarke:
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 Donald Field at 202-551-3680 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-03-14 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
CORRESP
Pulmatrix, Inc.
99 Hayden Avenue, Suite 390
Lexington, MA 02421
March 14,
2019
By EDGAR
United States Securities and
Exchange Commission
Division of Corporation Finance
100 F
Street N.E.
Washington, D.C. 20549
Attention: Tonya K.
Aldave
RE:
Pulmatrix, Inc.
Registration Statement on Form S-3
Filed March 12, 2019
Request for Acceleration
File No. 333-230225
Ladies and Gentlemen:
Pursuant to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”) under the
Securities Act of 1933, as amended, Pulmatrix, Inc. (the “Company”) hereby requests acceleration of the effective date of the above-mentioned Registration Statement on Form S-3 (the
“Registration Statement”) to 12:00 p.m., Eastern Time on March 15, 2019, or as soon thereafter as practicable.
Should any member of the staff of the U.S. Securities and Exchange Commission have any questions or comments with respect to this request,
please contact our counsel, Haynes and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974.
Very truly yours,
Pulmatrix, Inc.
By:
/s/ Robert W. Clarke
Robert W. Clarke, Ph.D.
Chief Financial Officer and President
cc: Rick A. Werner, Esq., Haynes and Boone, LLP
Jayun Koo, Esq., Haynes and Boone, LLP
2019-03-14 - UPLOAD - Pulmatrix, Inc.
March 14, 2019
Robert Clarke
Chief Executive Officer
Pulmatrix, Inc.
99 Hayden Avenue, Suite 390
Lexington, MA 02421
Re:Pulmatrix, Inc.
Registration Statement on Form S-3
Filed March 12, 2019
File No. 333-230225
Dear Mr. Clarke:
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 Tonya K. Aldave at (202) 551-3601 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Rick Werner, Esq.
2018-03-28 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm CORRESP OPPENHEIMER & CO. INC. 85 Broad Street New York, New York 10004 March 28, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Pulmatrix, Inc. Registration Statement, as amended on Form S-1 (File No. 333-223630) 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 several underwriters (the “Representative”), hereby joins in the request of Pulmatrix, Inc. that the effective date of the above-referenced Registration Statement be accelerated so that it will be declared effective at 4:00 p.m., Eastern Time, on Wednesday, March 28, 2018, 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 several underwriters, represents that the several underwriters have and will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, OPPENHEIMER & CO. INC. As representative of the several Underwriters OPPENHEIMER & CO. INC. By: /s/ Douglas Cameron Name: Douglas Cameron Title: Head of Equity Capital Markets
2018-03-28 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm CORRESP Pulmatrix, Inc. 99 Hayden Avenue, Suite 390 Lexington, MA 02421 March 28, 2018 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey Gabor Re: Pulmatrix, Inc. Registration Statement on Form S-1 File No. 333-223630 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Pulmatrix, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-223630), as amended (the “Registration Statement”), so that it may become effective at 4:00 p.m. Eastern time on Wednesday, March 28, 2018, or as soon thereafter as practicable; provided, that the Company respectfully requests that the Commission does not declare the Registration Statement effective until it receives telephonic or e-mail confirmation from the Company or its outside legal counsel, Haynes and Boone, LLP, on such date. Should any member of the staff of the Commission have any questions or comments with respect to this request, please contact Rick Werner of Haynes and Boone, LLP at 212-659-4974 or Matthew Fry of Haynes and Boone, LLP at 214-651-5443. Very truly yours, PULMATRIX, INC. By: /s/ Robert W. Clarke, Ph.D. Name: Title: Robert W. Clarke, Ph.D. Chief Executive Officer and President cc: Rick A. Werner, Esq., Haynes and Boone, LLP Matthew L. Fry, Esq., Haynes and Boone, LLP
2018-03-27 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm Request to Withdraw Pulmatrix, Inc. 99 Hayden Avenue, Suite 390 Lexington, MA 02421 March 27, 2018 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey Gabor Re: Pulmatrix, Inc. Registration Statement on Form S-1 File No. 333-223630 Ladies and Gentlemen: We hereby withdraw until further notice the request for acceleration of effectiveness of our Registration Statement on Form S-1 (File No. 333-223630), as amended, as per our letter dated Monday, March 26, 2018. Should any member of the staff of the Commission have any questions or comments with respect to this request, please contact Rick Werner of Haynes and Boone, LLP at 212-659-4974 or Matthew Fry of Haynes and Boone, LLP at 214-651-5443. Very truly yours, PULMATRIX, INC. By: /s/ Robert W. Clarke, Ph.D. Name: Title: Robert W. Clarke, Ph.D. Chief Executive Officer and President cc: Rick A. Werner, Esq., Haynes and Boone, LLP Matthew L. Fry, Esq., Haynes and Boone, LLP
2018-03-26 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm UW Acceleration Request OPPENHEIMER & CO. INC. 85 Broad Street New York, New York 10004 March 26, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Pulmatrix, Inc. Registration Statement, as amended on Form S-1 (File No. 333-223630) 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 several underwriters (the “Representative”), hereby joins in the request of Pulmatrix, Inc. that the effective date of the above-referenced Registration Statement be accelerated so that it will be declared effective at 5:15 p.m., Eastern Time, on Tuesday, March 27, 2018, 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 several underwriters, represents that the several underwriters have and will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, OPPENHEIMER & CO. INC. As representative of the several Underwriters OPPENHEIMER & CO. INC. By: /s/ Douglas Cameron Name: Title: Douglas Cameron Head of Equity Capital Markets
2018-03-26 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm CO Acceleration Request Pulmatrix, Inc. 99 Hayden Avenue, Suite 390 Lexington, MA 02421 March 26, 2018 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey Gabor Re: Pulmatrix, Inc. Registration Statement on Form S-1 File No. 333-223630 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Pulmatrix, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-223630), as amended (the “Registration Statement”), so that it may become effective at 5:15 p.m. Eastern time on Tuesday, March 27, 2018, or as soon thereafter as practicable; provided, that the Company respectfully requests that the Commission does not declare the Registration Statement effective until it receives telephonic or e-mail confirmation from the Company or its outside legal counsel, Haynes and Boone, LLP, on such date. Should any member of the staff of the Commission have any questions or comments with respect to this request, please contact Rick Werner of Haynes and Boone, LLP at 212-659-4974 or Matthew Fry of Haynes and Boone, LLP at 214-651-5443. Very truly yours, PULMATRIX, INC. By: /s/ Robert W. Clarke, Ph.D. Name: Title: Robert W. Clarke, Ph.D. Chief Executive Officer and President cc: Rick A. Werner, Esq., Haynes and Boone, LLP Matthew L. Fry, Esq., Haynes and Boone, LLP
2018-03-19 - UPLOAD - Pulmatrix, Inc.
March 16, 2018
Robert W. Clarke
Chief Executive Officer and President
Pulmatrix, Inc.
99 Hayden Avenue, Suite 390
Lexington, MA 02421
Re:Pulmatrix, Inc.
Registration Statement on Form S-1
Filed March 13, 2018
File No. 333-223630
Dear Dr. Clarke:
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 Jeffrey Gabor at 202-551-2544 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Rick Werner
2016-10-21 - UPLOAD - Pulmatrix, Inc.
Mail Stop 4546
October 2 1, 2016
Robert W. Clarke, Ph.D.
Chief Executive Officer and President
Pulmatrix, Inc.
99 Hayden Avenue, Suite 390
Lexington, MA 02421
Re: Pulmatrix, Inc.
Form 10 -K for Fiscal Year Ended December 31, 2015
Filed March 10, 2016
File No. 001 -36199
Dear Dr. Clarke :
We have completed our review of your filing. 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.
Sincerely,
p.p./s/ Michael Clampitt
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
2016-10-11 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm CORRESP October 11, 2016 VIA EDGAR Division of Corporation Finance Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attention: Suzanne Hayes Re: Pulmatrix, Inc. Form 10-K for Fiscal Year ended December 31, 2015 Filed March 10, 2016 File No. 001-36199 Ladies and Gentlemen: Reference is made to the letter dated September 28, 2016 (the “Comment Letter”) from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) regarding the Form 10-K for the fiscal year ended December 31, 2015 of Pulmatrix, Inc. (the “Company”), as originally filed with the Commission on March 10, 2016 (the “Annual Report”). Please see the Company’s responses to the Comment Letter below. The Company’s responses are numbered to correspond to the Staff’s comments as numbered in the Comment Letter. For your convenience, each of the Staff’s comments contained in the Comment Letter has been restated below in its entirety, with the Company’s corresponding response set forth immediately under such comment. Form 10-K for the Fiscal Year ended December 31, 2015 Business, page 2 1. We note that your License and Supply Agreement with Oculus requires you to make certain payments, including milestone payments and royalties. Please provide a description of the License and Supply Agreement to disclose: • the aggregate amount of milestone payments made to date; • the aggregate amount of potential future milestone payments; • the aggregate amount of potential future royalty payments; and • the royalty rate within a range that does not exceed ten percent (e.g., teens, twenties, etc.), Response: The Company notes the Staff’s comment and respectfully submits that it did not provide disclosure of the details of certain payments, including milestone payments and royalties, required under the terms of the License and Supply Agreement because these terms are no longer material to the Company’s business following the Merger (as hereinafter defined) and were superseded by the terms set forth in that certain side letter agreement with Oculus Innovative Sciences, Inc. (“Oculus”), dated March 13, 2015 (the “Oculus Side Letter”). As described in more detail in the Annual Report, on June 15, 2015, pursuant to the previously announced Agreement and Plan of Merger, dated March 13, 2015 (the “Merger Agreement”), by and among the Company (formerly known as Ruthigen, Inc.), Ruthigen Merger Corp., a Delaware corporation and a wholly owned subsidiary of the Company (“Merger Sub”), and Pulmatrix Operating Company, a Delaware corporation previously known as Pulmatrix Inc. (“Pulmatrix”), Merger Sub was merged with and into Pulmatrix, with Pulmatrix continuing after the merger as the surviving entity and a wholly owned subsidiary of the Company (the “Merger”). Prior to the Merger, Ruthigen was primarily engaged in the development of pharmaceutical-grade hypochlorous acid based therapeutics designed to prevent and treat infections related to post-operative invasive procedures, including RUT58-60 (the “Former Product”), Ruthigen’s lead drug candidate prior to the Merger (collectively, the “Former Business”). However, following the completion of the Merger, the Company shifted the focus of its business and resources to the development of products within the scope of Pulmatrix’s pre-Merger business plan, which was principally based on the development of novel inhaled therapeutic products intended to prevent and treat respiratory diseases and infections, including products based on iSPERSE (inhaled Small Particles Easily Respirable and Emitted), the Company’s proprietary dry powder delivery technology (collectively, the “New Business”). Prior to the Merger, the Former Product was developed in collaboration with Ruthigen’s former parent, Oculus, under the License and Supply Agreement, which granted certain exclusive patent rights that were material to the Former Business. Concurrent with the execution of the Merger Agreement, Pulmatrix, Ruthigen and Oculus entered into the Oculus Side Letter to clarify certain rights and obligations of each party following the closing date of the Merger with respect to certain agreements previously executed between Ruthigen and Oculus, including the License and Supply Agreement. Pursuant to the terms of the Oculus Side Letter, Oculus agreed, from the effective date of the Merger, to (i) waive, until one year following the effective date of the Merger (i.e., June 15, 2016), the Company’s obligations to use commercially reasonable efforts to develop and commercialize products licensed from Oculus under the outstanding License and Supply Agreement from claims and liabilities arising under the License and Supply Agreement, the separation agreement and the shared services agreement, each between Oculus and the Company, in favor of the Company and (ii) permit the Company to run a sale process for the Former Business, including any products licensed from Oculus, and to assign or delegate all of the Company’s surviving rights under the License and Supply Agreement, subject to certain consent rights of Oculus with respect to the identity of the proposed purchaser. Pursuant to the Oculus Side Letter, in the event of a sale of the Former Business with a minimum aggregate purchase price of $1 million, Oculus has a right of first refusal to acquire the Former Business on exactly the same terms, and in the event that Oculus does not exercise its right of first refusal and the aggregate purchase price exceeds $10 million, Oculus is entitled to receive 10% of the gross consideration from the sale of the Former Business. The Oculus Side Letter further provides that, if, at the end of the waiver period, no sale of the Former Business has occurred, then Oculus’ sole and exclusive remedy will be to terminate the License and Supply Agreement and reclaim all rights to the licensed products. As a result, during the waiver period following the closing of the Merger, the Company was under no obligation to achieve any milestone event and no payments accrued or became due and payable to Oculus under the License and Supply Agreement. Furthermore, because the waiver period has expired, the Company confirms that no other future payments will accrue or become due and payable to Oculus under the License and Supply Agreement as Oculus’ sole and exclusive remedy is to exercise its termination rights described above. In reaching the conclusion that payment terms under the License and Supply Agreement are not presently material to the Company and its New Business, the Company has applied the standard set forth in Basic Inc. v. Levinson, 485 U.S. 224 (1988), that a fact is material if there is “a substantial likelihood that [its] disclosure…would have been viewed by the reasonable investor as having significantly altered the total mix of information made available.” Basic Inc. v. Levinson, 485 U.S. at 231-32 (quotation marks and citations omitted). Based on the foregoing factors, the Company believes that a reasonable investor would not regard disclosure of any of the individual milestone payments or royalties payable under the terms of the License and Supply Agreement as significantly altering the total mix of information that is available concerning the Company and its New Business because they are no longer material under the terms of the Oculus Side Letter. In fact, the Company believes that amending its Annual Report to provide any further description of the immaterial milestones and milestone-based payments under the License and Supply Agreement would likely confuse or be misleading to investors because the Company does not intend to resume or pursue any further development or commercialization of products licensed from Oculus. Accordingly, the Company respectfully submits that it does not believe that any further description of the terms of the License and Supply Agreement as requested by the Staff would be material to an investor and, therefore, need not be disclosed in an amendment to its Annual Report. 2 Exhibits 2. Please file your February 8, 2015 advisory agreement with Palladium Capital Advisors and your March 24, 2015 long-acting muscarinic agent collaboration agreement with Mylan N.V. as exhibits. Response: The Company advises the Staff that it did not file its agreements with Palladium Capital Advisors (“Palladium”) and Mylan N.V. (“Mylan”) as exhibits to the Annual Report because the Company determined that they were not material contracts that the Company would be required to file under Item 601(b)(10) of Regulation S-K for the reasons set forth below. Palladium Advisory Agreement Item 601(b)(10)(i) requires that all contracts not made in the ordinary course of business which are material to the registrant and are to be performed in whole or in part at or after the filing of the report be filed as an exhibit to such report. As disclosed in the Company’s public filings, prior to the completion of the Merger, the Company entered into the advisory agreement with Palladium on February 8, 2015, pursuant to which Palladium agreed to (i) act the non-exclusive placement agent for the bridge loan financing in connection with the Merger that occurred on February 26, 2015 and (ii) serve as the Company’s non-exclusive advisor in connection with the Merger. As consideration for Palladium’s services under the engagement agreement, the Company paid Palladium commissions and a non-accountable expense reimbursement equal to 7% of the gross proceeds received from the bridge loan financing, or approximately $315,000, and issued to Palladium 235,844 shares of the Company’s common stock. In addition, on June 16, 2015 and September 4, 2015, in connection with the closing of the Merger and certain related transactions, the Company paid Palladium an aggregate of $1,102,608.91 in fees and commissions. Given the non-exclusive nature of the arrangement, the fact that there were no continuing obligations under the agreement after the Merger and the insubstantial amount of consideration paid pursuant to the advisory agreement, the Company determined that the agreement with Palladium was not a material. Accordingly, because the agreement was not material to the Company and all obligations thereunder had been performed in full prior to the filing of the Annual Report, the Company believes that it was not required to be filed as an exhibit under Item 601(b)(10)(i). Mylan Collaboration Agreement Item 601(b)(10)(ii) provides that if an agreement is such as ordinarily accompanies the kind of business conducted by the registrant, it will be deemed to have been made in the ordinary course of business, and therefore not required to be filed, unless the agreement is one upon which the registrant’s business is “substantially dependent,” in which case it is required to be filed “except where immaterial in amount or significance.” The Company assessed the materiality of its collaboration agreement with Mylan under this framework and determined, as further described below, that (i) the agreement was made in the ordinary course of the Company’s business and (ii) the Company’s business is not substantially dependent on the agreement. 3 As noted in response to Comment 1, the Company’s New Business focuses on the development of novel inhaled therapeutic products intended to prevent and treat respiratory diseases and infections, including cystic fibrosis, idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease (“COPD”). Specifically, the Company designs and develops products based on its proprietary dry powder delivery technology iSPERSE. The Company’s proprietary product pipeline includes PUR1900, an inhaled anti-fungal for patients with cystic fibrosis as well as PUR1500, an inhaled product for the treatment of idiopathic pulmonary fibrosis. The Company is also pursuing opportunities to advance the clinical development of its lead COPD product candidate, PUR0200. Consistent with other clinical stage companies in the biopharmaceutical industry, the Company enters into collaboration agreements in the ordinary course of its business to advance the clinical development of its iSPERSE-based therapeutic candidates. Pursuant to the collaboration agreement with Mylan, the Company agreed to work with Mylan to develop a pharmacokinetic study plan and conduct certain clinical trials related to PUR0200, which Mylan agreed to fund by reimbursing the Company up to approximately $1.9 million for its third-party out-of-pocket expenses incurred in connection with the agreed clinical studies. In addition, as consideration for Mylan funding the studies, the Company granted Mylan an option to negotiate for the exclusive right to develop, manufacture, commercialize and market any resulting products outside the United States for one hundred eighty (180) days following the date that the Company delivers a report detailing the outcome of the pharmacokinetic studies of PUR0200 to Mylan, in exchange for the Company’s receipt of gross profit share of up to twenty percent (20%) of the gross profit of such pharmaceutical company’s sales of PUR0200 outside the United States. Although the collaboration agreement with Mylan has provided strategic value to the Company in helping to advance the clinical development of PUR0200, the Company’s business is not substantially dependent on the agreement from an operational or financial perspective. PUR0200 is an early-stage COPD product candidate that the Company is pursuing in addition to its other proprietary products, including its core focus on advancing the research and development of PUR1900. The agreement is also immaterial in amount and significance, as the Company has not derived any substantial revenue from its collaboration with Mylan and does not expect to generate any substantial revenue from such agreement in the near future. Furthermore, because PUR0200 is in the early stages of clinical development, the Company believes that Mylan’s option to negotiate for exclusive rights with respect to any resulting products addresses a remote contingency that is not expected to affect any of the Company’s near-term operations or obligations under the agreement. Based on the foregoing, the Company maintains that it was not required to file the collaboration agreement as an exhibit under Item 601(b)(10)(ii). 3. Please mark Exhibit 10.17 as having parts omitted pursuant to a Confidential Treatment Request. Response: The Company notes the Staff’s comment and confirms that it will include and mark Exhibit 10.17 as having parts omitted pursuant to a Confidential Treatment Request in its upcoming Quarterly Report on Form 10-Q. 4 At the request of the Staff, the Company acknowledges that: • the Company is responsible for the adequacy and accuracy of the disclosure in the filing; • staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and • the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please direct any questions or comments concerning this response to Rick A. Werner, Esq., Haynes and Boone, LLP at (212) 659-4974 or at Rick.Werner@haynesboone.com. Very truly yours, /s/ Robert W. Clarke, Ph.D. Robert W. Clarke, Ph.D. Chief Executive Officer and President cc: Rick Werner, Esq. 5
2016-09-29 - UPLOAD - Pulmatrix, Inc.
Mail Stop 4546
September 2 8, 2016
Robert W. Clarke, Ph.D.
Chief Executive Officer and President
Pulmatrix, Inc.
99 Hayden Avenue, Suite 390
Lexington, MA 02421
Re: Pulmatrix, Inc.
Form 10 -K for Fiscal Year Ended December 31, 2015
Filed March 10, 2016
File No. 001 -36199
Dear Dr. Clarke :
We have reviewed your filing 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 these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and cir cumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Business, page 2
1. We note that your License and Supply Agreement wi th Oculus requires you to make
certain payments, including milestone payments an d royalties. Please provide a
description of the License and Supply Agreement to disclose:
the aggregate amount of milestone payments made to date;
the aggregate amount of potential future milestone payments;
the aggregate amount of potential future royalty payments; and
the royalty rate within a range that does not exceed ten percent (e.g. teens,
twenties, etc.).
Exhibits
2. Please file your February 8, 2015 advisory agreement with Palladium Capital Advisors
and your March 24, 2015 long -acting muscarinic agent collaboration agreement with
Mylan N.V. as exhibits.
Robert W. Clarke, Ph.D.
Pulmatrix, Inc.
September 2 8, 2016
Page 2
3. Please mark Exhibit 10.17 as having parts omitted pursuant to a Confidential Treatment
Request.
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 Exchange Act of
1934 and all applicable Exchange Act rules require. Since the compa ny and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In responding to our comments, please provide a written statement from the co mpany
acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States.
Please contact Michael Gershon at (202) 551 -6598 or Michael Clam pitt at (202) 551 -
3434 with any questions.
Sincerely,
p.p./s/ Michael Clampitt
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
2016-08-01 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm CORRESP Pulmatrix, Inc. 99 Hayden Avenue | Suite 390 Lexington, MA 02421 August 1, 2016 VIA EDGAR AND FACSIMILE U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Attn: Ms. Suzanne Hayes Re: Pulmatrix, Inc. Registration Statement on Form S-3, originally filed on July 15, 2016 File No. 333-212546, as amended (the “Registration Statement”) Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Pulmatrix, Inc. (the “Company”) hereby respectfully requests acceleration of the effective date of the Registration Statement so that it may become effective at 4:30 p.m., Eastern Time, on August 3, 2016, or as soon thereafter as practicable. In connection with the Company’s request for acceleration of the effective date of the Registration Statement, the Company acknowledges the following: • should the U.S. 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. Should any member of the staff of the Commission have any questions or comments with respect to this request, please contact our counsel, Haynes and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974. Very truly yours, Pulmatrix, Inc. By: /s/ Robert W. Clarke, Ph.D. Robert W. Clarke, Ph.D. Chief Executive Officer
2016-07-29 - CORRESP - Pulmatrix, Inc.
CORRESP 1 filename1.htm CORRESP July 29, 2016 VIA EDGAR Division of Corporation Finance Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attention: Suzanne Hayes Re: Pulmatrix, Inc. Registration Statement on Form S-3 Filed July 15, 2016 File No. 333-212546 Ladies and Gentlemen: Reference is made to the letter dated July 25, 2016 (the “Comment Letter”) from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) regarding the Registration Statement on Form S-3 filed by Pulmatrix, Inc. (the “Company”). Please see the Company’s responses to the Comment Letter below. The Company’s responses are numbered to correspond to the Staff’s comments as numbered in the Comment Letter. For your convenience, each of the Staff’s comments contained in the Comment Letter have been restated below in their entirety, with the Company’s corresponding response set forth immediately under such comment. Concurrently with the submission of this letter, the Company is filing Amendment No. 1 to the Registration Statement (“Amendment No. 1”) via EDGAR. Registration Statement on Form S-3 Exhibit 5.1 1. We note your disclosure on page 12 that each warrant agreement and any warrants issued under the warrant agreements will be governed by New York law. Please have counsel revise the legality opinion to opine that the warrants are binding obligations of the registrant under the law of the jurisdiction governing the warrants. For guidance, please refer to Section II.B.1.f of Staff Legal Bulletin No. 19 (October 14, 2011). Response: We acknowledge the Staff’s comment and have obtained and filed a new legal opinion of Haynes and Boone, LLP, reflecting the requested revisions. Please see Exhibit 5.1 to Amendment No. 1. Please direct any questions or comments concerning this response to Rick A. Werner, Esq., Haynes and Boone, LLP at (212) 659-4974 or at Rick.Werner@haynesboone.com. Very truly yours, /s/ Robert W. Clarke, Ph.D. Robert W. Clarke, Ph.D., Chief Executive Officer and President cc: Rick Werner, Esq.
2016-07-25 - UPLOAD - Pulmatrix, Inc.
Mail Stop 4546 July 25, 2016 Robert W. Clarke, Ph.D. Chief Executive Officer and President Pulmatrix, Inc. 99 Hayden Avenue, Suite 390 Lexington, MA 02421 Re: Pulmatrix, Inc. Registration Statement on Form S-3 Filed July 15, 2016 File No. 333-212546 Dear Dr. Clarke : We have limited our review of your registration statement to the issue we have addressed in our 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 reviewin g any amendment to your registration statement and the information you provide in response to this comment , we may have additional comments. Exhibit 5.1 1. We note your disclosure on page 12 that each warrant agreement and any warrants issued under the warrant agreements will be governed by New York law. Please have counsel revise the legality opinion to opine that the warrants are binding obligations of the registrant under the law of the jurisdiction governing the warrants. For guidance, please refer to Section II.B.1.f of Staff Legal Bulletin No. 19 (October 14, 2011). 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 1 933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Robert W. Clarke, Ph.D. Pulmatrix, Inc. July 25, 2016 Page 2 Notwithst anding our comment , in the event you request acceleration of the effective date of the pending registration 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 effect iveness 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 acceler ation 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. Please contact Irene Paik at (202) 551 -6553 or Mary Beth Breslin at (202) 551 -3625 with any other questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Rick A. Werner, Esq. Haynes and Boone, LLP
2014-03-20 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
Ruthigen, Inc.
2455 Bennett Valley Rd., Suite C116
Santa Rosa, California 95404
March 20, 2014
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Amy Reischauer
Re: Ruthigen, Inc.
Registration
Statement on Form S-1
File
No. 333-190476
Request
for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461
of Regulation C promulgated under the Securities Act of 1933, as amended, Ruthigen, Inc. (the “Registrant”) hereby
requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-190476), as amended (the
“Registration Statement”), so that it may become effective at 9:00 a.m. (Washington, D.C. time) on March 21, 2014,
or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff.
This request for acceleration is subject, however, to your receiving a telephone call prior to such time from our legal counsel,
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., confirming this request. Under separate cover, you will receive a letter from
the managing underwriter of the proposed offering joining in the Registrant’s request for acceleration of the effectiveness
of the Registration Statement.
The Registrant hereby acknowledges that:
(i)
should the U.S. 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 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.
[remainder of page intentionally left
blank]
Please
call Linda K. Rockett (617-348-4888) of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.,
counsel to the Company, with any comments or questions regarding this matter.
Very truly yours,
Ruthigen, Inc.
By:
/s/ Hojabr Alimi
Name: Hojabr Alimi
Title: Chief Executive Officer, Chief Science Officer
and Chairman of the Board of Directors
cc: Securities and Exchange Commission
Jeffrey Riedler, Assistant
Director
Ibolya Ignat
Mark Brunhofer
Amy Reischauer
Daniel Greenspan
Ruthigen, Inc.
Sameer
Harish, Chief Financial Officer
Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo, P.C.
Linda
K. Rockett, Esq.
Merav
Gershtenman, Esq.
Ellenoff Grossman
& Schole LLP
Joseph A. Smith, Esq.
Robert F. Charron,
Esq.
Marcum LLP
Anthony Basile
Mitchell Watt
2014-03-14 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
Ruthigen, Inc.
2455 Bennett Valley Rd., Suite C116
Santa Rosa, California 95404
March 14, 2014
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Amy Reischauer
Re: Ruthigen, Inc.
Registration
Statement on Form S-1
File
No. 333-190476
Request
for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461
of Regulation C promulgated under the Securities Act of 1933, as amended, Ruthigen, Inc. (the “Registrant”) hereby
requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-190476), as amended (the
“Registration Statement”), so that it may become effective at 4:00 p.m. (Washington, D.C. time) on March 18, 2014,
or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff.
This request for acceleration is subject, however, to your receiving a telephone call prior to such time from our legal counsel,
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., confirming this request. Under separate cover, you will receive a letter from
the managing underwriter of the proposed offering joining in the Registrant’s request for acceleration of the effectiveness
of the Registration Statement.
The Registrant hereby acknowledges that:
(i)
should the U.S. 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 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.
[remainder of page intentionally left
blank]
Please
call Linda K. Rockett (617-348-4888) of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.,
counsel to the Company, with any comments or questions regarding this matter.
Very truly yours,
Ruthigen, Inc.
By:
/s/ Hojabr Alimi
Name: Hojabr Alimi
Title: Chief Executive Officer, Chief Science Officer
and Chairman of the Board of Directors
cc: Securities and Exchange Commission
Jeffrey Riedler, Assistant
Director
Ibolya Ignat
Mark Brunhofer
Amy Reischauer
Daniel Greenspan
Ruthigen, Inc.
Sameer
Harish, Chief Financial Officer
Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo, P.C.
Linda
K. Rockett, Esq.
Merav
Gershtenman, Esq.
Ellenoff Grossman
& Schole LLP
Joseph A. Smith, Esq.
Robert F. Charron,
Esq.
Marcum LLP
Anthony Basile
Mitchell Watt
2014-03-10 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
Linda Rockett | 617 348 4888 | lrockett@mintz.com
One Financial Center
Boston, MA 02111
617-542-6000
617-542-2241 fax
www.mintz.com
March
10, 2014
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 3561
Washington, D.C. 20549
Attention: Jeffrey Riedler, Assistant Director
Re: Ruthigen, Inc.
Registration Statement on Form S-1
Filed February 24, 2014
File No. 333-19047
Ladies and Gentlemen:
We are submitting this
letter on behalf of Ruthigen, Inc. (the “Company”) in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) received by letter dated March 6, 2014 (the “Comment
Letter”) from Jeffrey P. Riedler, Assistant Director, to Hojabr Alimi, the Company’s Chief Executive Officer, relating
to the above-referenced registration statement on Form S-1 of the Company filed with the Commission on February 24, 2014. In conjunction
with this letter, the Company is filing Amendment No. 5 to the registration statement (“Amendment No. 5” and,
as amended, the “Registration Statement”).
For convenient reference,
we have set forth below in italics each of the Staff’s comments set forth in the Comment Letter and have keyed the Company’s
responses to the numbering of the comments and the headings used in the Comment Letter. All of the responses are based on information
provided to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. by representatives of the Company. Where appropriate, the Company
has responded to the Staff’s comments by making changes to the disclosure in the Registration Statement as set forth in Amendment
No. 5. Page numbers referred to in the responses reference the applicable pages of Amendment No. 5.
We are providing by
overnight delivery to each of Ibolya Ignat, Mark Brunhofer, Amy Reischauer, Daniel Greenspan and Jeffrey Riedler of the Staff one
courtesy copy of this letter and Amendment No. 5 that have been marked to show changes from the filing of Amendment No. 4 to the
Registration Statement on Form S-1 filed on February 24, 2014.
Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C.
Boston
| London | Los Angeles | New York | San Diego | San Francisco | Stamford | Washington
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
March 10, 2014
Page 2
Cover Page Exhibit 5.1
1. You appear to be registering the offer and sale of units consisting of
one share of common stock and one Series A warrant. Please revise your fee table and the cover page to your prospectus to clarify
that you are registering these units in addition to their component securities. In addition, please file a revised legal opinion
that includes an opinion with respect to the units.
Response: In
response to the Staff’s comment, the Company has revised the disclosure throughout the Registration Statement, including
the fee table, prospectus and legal opinion, to refer to the offer and sale of units, in addition to the component securities.
Summary Financial Information, page
11
2. Please tell us why you exclude the effect of the January 31, 2014 funding
agreement with Oculus and your obligation to repay the amounts disclosed on page 21 from your “as adjusted” presentation.
Please reference for us the authoritative literature you rely upon to support your position. In addition, please revise your footnote
(1) disclosure to refer to your unit offering instead of referring to a sale of shares.
Response: The
Company has amended its “as adjusted” presentation to reflect the full expenses related to the Company’s initial
public offering, including all accounts payables and the payments due to Oculus upon the closing of the initial public offering,
as more fully described on page 21 of Amendment No. 4 to Form S-1 filed on February 24, 2014 and will be described on pages 19-20
of Amendment No. 5. The payments include $916,000 owed in payables to Oculus and $430,000 in other offering-related accounts payables
as of December 31, 2013, and an estimated $760,000 of expenses incurred for the quarter ending March 31, 2014, all of which the
Company will repay Oculus from the proceeds of the offering. The Company expects to raise $18.2 million in gross proceeds
from its initial public offering, less approximately $1.5 million in underwriter’s commissions, $0.2 million in underwriter’s
offering expenses, and $2.1 million in offering-related expenses, which include, among other items, all payables to Oculus, and
which the Company anticipates will result in an estimated net proceeds to the Company of approximately $14.4 million, which is
the amount consistently disclosed throughout the Registration Statement. In addition, the Company has revised the footnote disclosures
related to the “as adjusted” presentation to refer to the units, consisting of one share of common stock and one Series
A warrant.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
March 10, 2014
Page 3
Capitalization, page 43
3. Please revise your pro forma as adjusted presentation to give effect
to your units offering. Your current discussion refers to a common stock offering without acknowledging the other elements of the
units offered for sale.
Response: In
response to the Staff’s comment, the Company has revised the pro forma “as adjusted” presentation to give effect
to the issuance of (i) the shares of common stock included in the units, which would be the only additional shares of common stock
outstanding immediately following the closing of the offering; (ii) the shares of common stock included in the units, which would
be the only additional shares of common stock outstanding immediately following the closing of the offering, plus the shares of
common stock issuable upon exercise of the Series A Warrants included in the units; and (iii) the shares of common stock included
in the units, which would be the only additional shares of common stock outstanding immediately following the closing of the offering,
plus the shares of common stock issuable upon exercise of the Series A Warrants included in the units, plus the shares of common
stock issuable upon exercise of the Series B Warrants issuable upon exercise of the Series A Warrants. The Company has included
additional disclosure that sets forth the conditions that would need to be met before the shares of common stock underlying the
Series A Warrants and the Series B Warrants would actually be issued and impact the Company’s capitalization, including
the receipt of additional proceeds, since the warrants are exercisable for cash.
* * * * *
When appropriate, the
Company will provide a written request for acceleration of the effective date of the Registration Statement and will include the
requested “Tandy” language therein. The Company and the underwriters are aware of their respective obligations under
Rules 460 and 461 regarding requesting acceleration of the effectiveness of the Registration Statement.
We hope that the above
responses and the related revisions to the Registration Statement will be acceptable to the Staff. Please do not hesitate to contact
me at 617-348-4888 or lrockett@mintz.com with any comments or questions regarding the
Registration Statement and this letter. We thank you for your time and attention.
Sincerely,
/s/ Linda K. Rockett
Linda K. Rockett
cc: Securities and Exchange Commission
Jeffrey Riedler, Assistant
Director
Ibolya Ignat
Mark Brunhofer
Amy Reischauer
Daniel Greenspan
Ruthigen, Inc.
Hojabr Alimi, Chief Executive Officer
Sameer Harish, Chief Financial Officer
Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo, P.C.
Ivan K. Blumenthal, Esq.
Merav Gershtenman, Esq.
Ellenoff Grossman
& Schole LLP
Joseph A. Smith, Esq.
Robert F. Charron,
Esq.
Marcum LLP
Anthony Basile
Mitchell Watt
2014-03-06 - UPLOAD - Pulmatrix, Inc.
March 6, 2014 Via E -Mail Hojabr Alimi Chief Executive Officer Ruthigen, Inc. 2455 Bennett Valley Road, Suite C116 Santa Rosa, CA Re: Ruthigen, Inc. Registration Statement on Form S -1 Filed February 24, 2014 File No. 333 -190476 Dear Mr. Alimi : 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. Cover Page Exhibit 5.1 1. You appear to be registering the offer and sale of units consisting of one share of common stock and one Series A warrant. Please revise your fee table and the cover p age to your prospectus to clarify that you are registering these units in addition to their component securities. In addition, please file a revised legal opinion that includes an opinion with respect to the units. Summary Financial Information, page 11 2. Please tell us why you exclud e the effect of the January 31, 2014 funding agreement with Oculus and your obligation to repay the amounts disclosed on page 21 from your “as adjusted” presentation. Please reference for us the authoritative literature you r ely upon Hojabr Alimi Ruthigen, Inc. March 6, 2014 Page 2 to support your position. In addition, please revise your footnote (1) disclosure to refer to your unit offering instead of referring to a sale of shares. Capitalization, page 43 3. Please revise your pro forma as adjusted presentation to give ef fect to your units offering. Your current discussion refers to a common stock offering without acknowledging the other elements of the units offered for sale. 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 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 you 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 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. 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 o f 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. Hojabr Alimi Ruthigen, Inc. March 6, 2014 Page 3 You may contact Ibolya Ignat at (202) 551 -3656 or Mark Brunhofer at (202) 551 -3638 if you have questions regarding comments on the financial statements and related matters. Please contact Amy Reischauer at (202) 551 -3793, Daniel Greenspan at (202) 551 -3623, or me at (202) 551-3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -Mail Ivan Blumenthal Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 666 Third Avenue New York, NY 10017
2013-11-18 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
AEGIS CAPITAL CORP.
810 Seventh Avenue
New York, New York 10019
November 18,
2013
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jeffrey Riedler, Assistant Director
Re: Ruthigen, Inc. (the “Company”)
File No. 333-190476
Registration Statement on Form S-1
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended
(the “Securities Act”), we, the representative of the several underwriters (the “Representative”), hereby
join in the request of the Company that the effective time of the above-referenced Registration Statement be accelerated so that
it will be declared effective at 4:00 p.m. Eastern Time on November 20, 2013, or as soon thereafter as practicable.
Pursuant to Rule 460
under the Securities Act, please be advised that during the period from November 7, 2013 to the date of this letter, the preliminary
prospectus, dated November 6, 2013, in connection with the Registration Statement was distributed approximately as follows:
Sent to Underwriters – 70 + E-red
Sent to Dealers: 350 + E-red
Sent to Institutional Investors: 150 +E-red
Sent to Others: 0
Total: 570 + E-red
The Representative
confirms on behalf of itself and the several underwriters that they have complied and will continue to comply with the requirements
of Rule 15c2-8 promulgated under of the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Very truly yours,
AEGIS CAPITAL CORP.
as representative of the underwriters
By: /s/
Sam Guidetti
Name: Sam Guidetti
Title: Chief Compliance Officer
2013-11-18 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
Ruthigen, Inc.
2455 Bennett Valley Rd., Suite C116
Santa Rosa, California 95404
November 18, 2013
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jeffrey Riedler, Assistant Director
Re: Ruthigen, Inc.
Registration
Statement on Form S-1
File
No. 333-190476
Request
for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461
of Regulation C promulgated under the Securities Act of 1933, as amended, Ruthigen, Inc. (the “Registrant”) hereby
requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-190476), as amended (the
“Registration Statement”), so that it may become effective at 4:00 p.m. (Washington, D.C. time) on November 20, 2013,
or as soon thereafter as practicable. Under separate cover, you will receive a letter from the managing underwriter of the proposed
offering joining in the Registrant’s request for acceleration of the effectiveness of the Registration Statement.
The Registrant hereby acknowledges that:
(i)
should the U.S. 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 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.
[remainder of page intentionally left
blank]
Please
call Linda K. Rockett (617-348-4888) of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.,
counsel to the Company, with any comments or questions regarding this matter.
Very truly yours,
Ruthigen, Inc.
By:
/s/ Hojabr Alimi
Name:
Hojabr Alimi
Title:
Chief Executive Officer, Chief Science Officer and
Chairman of the Board of Directors
cc: Securities and Exchange Commission
Jeffrey Riedler, Assistant
Director
Ibolya Ignat
Mark Brunhofer
Amy Reischauer
Daniel Greenspan
Ruthigen, Inc.
Hojabr Alimi,
Chief Executive Officer, Chief Science Officer and
Chairman of the Board of Directors
Sameer Harish, Chief Financial Officer
Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo, P.C.
Ivan
K. Blumenthal, Esq.
Linda
K. Rockett, Esq.
Sichenzia Ross
Friedman Ference LLP
Jeffrey J. Fessler,
Esq.
Stephen A. Cohen, Esq.
Marcum LLP
Anthony Basile
Mitchell Watt
2013-10-15 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
Linda Rockett | 617 348
4888 | lrockett@mintz.com
One Financial Center
Boston, MA 02111
617-542-6000
617-542-2241 fax
www.mintz.com
October 15, 2013
Via EDGAR and by Federal Express
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 3561
Washington, D.C. 20549
Attention: Jeffrey Riedler, Assistant Director
Re:
Ruthigen, Inc.
Registration Statement on Form S-1
Filed August 8, 2013
File No. 333-190476
Ladies and Gentlemen:
We are submitting this letter on behalf
of Ruthigen, Inc. (the “Company”) in response to comments from the staff (the “Staff”) of
the Securities and Exchange Commission (the “Commission”) received by letter dated August 23, 2013 (the “Comment
Letter”) from Jeffrey P. Riedler, Assistant Director, to Hojabr Alimi, the Company’s Chief Executive Officer, relating
to the above-referenced registration statement on Form S-1 of the Company filed with the Commission on August 8, 2013 (the “Initial
Public Filing”). In conjunction with this letter, the Company is filing Amendment No. 1 to the registration statement
(“Amendment No. 1” and, as amended, the “Registration Statement”).
For convenient reference, we have set forth
below in italics each of the Staff’s comments set forth in the Comment Letter and have keyed the Company’s responses
to the numbering of the comments and the headings used in the Comment Letter. All of the responses are based on information provided
to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. by representatives of the Company. Where appropriate, the Company has responded
to the Staff’s comments by making changes to the disclosure in the Registration Statement as set forth in Amendment No. 1.
Page numbers referred to in the responses reference the applicable pages of Amendment No. 1.
We are providing by overnight delivery to
Daniel Greenspan of the Staff five courtesy copies of this letter and Amendment No. 1 that have been marked to show changes from
the filing of the Initial Public Filing filed on August 8, 2013.
Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C.
Boston
| London | Los Angeles | New York | San Diego | San Francisco | Stamford | Washington
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
October 15, 2013
Page 2
1. Please revise your financial statements and MD&A with updated interim financial information through the period ended
June 30, 2013.
Response: The Company has revised the
Registration Statement throughout to include updated interim financial information for the period ended June 30, 2013.
2. We acknowledge your response to comment 6 and are uncertain why the fact that all direct or indirect
product related costs for RUT58-60 are included in your historical financial statements is determinative as to why carve-out financial
statements from Oculus are not necessary. With a view toward telling us more about the development history of RUT58-60, please
revise your disclosure in Business to provide a chronology of the activities related to the development of RUT58-60. At a minimum,
please disclose:
· When Oculus conceived of RUT58-60;
· The nature and timing of discovery activities;
· The nature and timing of formulation activities;
· The nature and timing of other pre-clinical activities including in vitro and toxicology studies;
· The number of predecessor formulations and when each was founded that form the basis for the
current formulation of RUT58-60;
· When the new, unique hypochlorous acid-based formulations that were disclosed to Oculus’ intellectual property counsel
in December 2012 were founded and how they relate to the formulations in the preceding bullet;
· The costs in terms of dollars and/or manpower associated with the discovery and formulation
activities, separating the activities untaken by Oculus from those you undertook.
In your response, separately tell us whether Oculus
sponsored the initial clinical trials conducted by physicians in Mexico that demonstrated the faster tissue healing associated
with hypochlorous acid products as disclosed on page 3. In addition tell us what information the Oculus Board of Directors reviewed
when, in November 2012, it directed Oculus management to explore the idea of creating a wholly-owned subsidiary within which to
pursue the development of RUT58-60.
Response: In addition to Regulation S-X, the
Company has reviewed and considered the SEC’s guidance on the issue of historical and carve-out financial statements set
forth in SEC SAB Topic 1.B, the remarks by Leslie Overton, SEC Division of Corporation Finance, at the 2001 AICPA Annual National
Conference on Current SEC Developments, and SEC SAB Topic 5.Z and, in light of such guidance, the Company has revised its audited
financial statements that are included in the Registration Statement to reflect the activities of Ruthigen (carve-out activities)
from Oculus for the period beginning on October 20, 2011 (“Inception”), which is the date that the operations associated
with Ruthigen commenced. Accordingly, the revised Registration Statement now includes audited financial statements that capture
the activities of Ruthigen for the year ended March 31, 2013 and for the period from Inception to March 31, 2012, plus unaudited
interim financial statements for the three months ended June 30, 2013 and 2012.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
October 15, 2013
Page 3
The Company has revised the disclosures through the
Registration Statement to reflect these operations and has included a new subsection entitled “Development History of RUT58-60”
on page 54 of the “Business” section that describes the discovery, formulation and development activities
of Ruthigen, which commenced prior to the formal incorporation of Ruthigen as a separate legal entity, that led to RUT58-60 as
the first target in a new class of products being pursued by Ruthigen. Other than as set forth below, these new disclosures
address, among other things, those items in the bullet points and the November 2012 back up request identified by the Staff in
this comment 2.
Due to the significant costs associated with preclinical
activities, including animal, in vitro and toxicology studies, no preclinical studies were conducted for RUT58-60 prior to the
Company’s formal incorporation on January 18, 2013; all preclinical studies have been conducted since that time. The disclosure
under “Select Pathogen Activity of RUT58-60” in the “Business” section describes the results of certain
of the Company’s preclinical studies for RUT58-60.
The Company has revised the Registration Statement
on pages 3 and 46 to remove the potentially confusing reference to clinical trials conducted in Mexico and in lieu thereof, the
Company has revised the disclosure to more generally refer to peer-reviewed journals that have published studies demonstrating
faster tissue healing times with hypochlorous acid based products. One example of such a study is the Landsman study, described
on page 52 of the Registration Statement, which was a clinical trial sponsored by Oculus, which used Oculus’ hypochlorous
acid based product (not RUT58-60).
With respect to the clinical trials conducted by physicians
in Mexico, the Company has removed all references to such trials from the Registration Statement. We supplementally advise the
Staff that Oculus made certain payments to the physician conducting the clinical trial in Mexico and provided the physician with
Oculus’ hypochlorous acid based product to complete the trial.
3. We note that you are requesting confidential treatment for portions of Exhibit 10.4. Please be advised that we will review
your request for confidential treatment once it is received and will provide any comments under separate cover. We will not be
able to process any request for acceleration of the effective date of the pending registration statement until any such confidential
treatment request is resolved.
Response: The Company acknowledges the Staff’s
comment. Oculus, on behalf of the Company, filed a joint Application for Confidential Treatment with the Secretary of the Commission
on August 8, 2013 for portions of Exhibit 10.4 of the Company’s Registration Statement and Exhibit 10.1 to Oculus’
Current Report on Form 8-K originally filed with the Commission on June 7, 2013. On August 23, 2013, the Company delivered separately
to the Staff a copy of the joint Application for Confidential Treatment, dated August 8, 2013, which was submitted to the Secretary
of the Commission by Oculus. On September 11, 2013, Oculus, on behalf of itself and the Company, received a comment from the Staff
with respect to certain of the initially proposed redactions set forth in the Company’s Exhibit 10.4 to the Registration
Statement and Exhibit 10.1 to Oculus’ Current Report on Form 8-K originally filed with the Commission on June 7, 2013. In
response to the comment, on September 24, 2013, Oculus filed an Amendment No. 1 to its Current Report on Form 8-K originally filed
with the Commission on June 7, 2013 to provide certain previously omitted portions of the license agreement, filed as Exhibit 10.1
to the Company’s original Current Report on Form 8-K. Namely, as requested by the Commission, Oculus restored the amounts
of the milestone payments set forth in Section 7.1 of the license agreement. Accordingly, Exhibit 10.1 was re-filed with fewer
redactions and Oculus no longer requests confidential treatment for the amounts of the milestone payments set forth in Section
7.1 of the license agreement.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
October 15, 2013
Page 4
Similarly, the Company has also re-filed Exhibit 10.4
of its Registration Statement as part of Amendment No. 1, with fewer redactions to the license agreement filed as such Exhibit,
which are the same as those redactions in Oculus’ Exhibit 10.1. The joint Application for Confidential Treatment was also
revised to reflect this amended disclosure and was jointly re-submitted to the Commission by Oculus and the Company on September
24, 2013.
SEC Comment Letter dated June 21, 2013
In addition, in response to comment 3 in the Staff’s
comment letter to the Company dated June 21, 2013, we call the Staff’s attention to the new graphics that appear on the front
cover of the prospectus included in the Registration Statement.
Other
In addition to revising the Registration Statement
to include responses to the Staff’s comments above, the Company has revised the Registration Statement with respect to new
disclosures relating to, among other things, the reincorporation of the Company from Nevada to Delaware on September 25, 2013 and
the commensurate changes to the disclosures regarding Delaware corporate law, a 1-for-2.5 reverse stock split on September 25,
2013, the pricing information for the offering, and revised disclosures regarding Oculus’ secured debt facility, in light
of a new arrangement that Oculus has entered into with its lenders, the result of which is beneficial to the Company.
* * * * *
When appropriate, the Company will provide
a written request for acceleration of the effective date of the Registration Statement and will include the requested “Tandy”
language therein. The Company and the underwriters are aware of their respective obligations under Rules 460 and 461 regarding
requesting acceleration of the effectiveness of the Registration Statement.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
October 15, 2013
Page 5
We hope that the above responses and the
related revisions to the Registration Statement will be acceptable to the Staff. Please do not hesitate to contact me at 617-348-4888
or lrockett@mintz.com with any comments or questions regarding the Registration Statement and this letter. We thank you for your
time and attention.
Sincerely,
/s/ Linda K. Rockett
Linda K. Rockett
cc:
Securities and Exchange Commission
Jeffrey Riedler, Assistant Director
Ibolya Ignat
Mark Brunhofer
Amy Reischauer
Daniel Greenspan
Ruthigen, Inc.
Hojabr Alimi, Chief Executive Officer
Sameer Harish, Chief Financial Officer
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Ivan K. Blumenthal, Esq.
Merav Gershtenman, Esq.
Sichenzia Ross Friedman Ference LLP
Jeffrey J. Fessler, Esq.
Stephen A. Cohen, Esq.
Marcum LLP
Anthony Basile
Mitchell Watt
2013-08-23 - UPLOAD - Pulmatrix, Inc.
August 23, 2013 Via E -Mail Hojabr Alimi Chief Executive Officer Ruthigen, Inc. 2455 Bennett Valley Road, Suite C116 Santa Rosa, CA Re: Ruthigen, Inc. Registration Statement on Form S-1 Filed August 8, 2013 File No. 333 -190476 Dear Mr. Alimi : 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. 1. Please revise your financial statements and MD&A with updated interim financial information through the period ended June 30, 2013. 2. We acknowledge your response to comment 6 and are uncertain why the fact that all direct or indirect product related costs for RUT58 -60 are included in your historical financial statements is determinative as to why carve -out financial statements from Oculus are not necessary. With a view toward telling us more about the development history of RUT58 -60, please revise your disclosure in Business to provide a chronology of the act ivities related to the development of RUT58 -60. At a minimum, please disclose: Hojabr Alimi Chief Executive Officer Ruthigen, Inc. August 23, 2013 Page 2 When Oculus conceived of RUT58 -60; The nature and timing of discovery activities; The nature and timing of formulation activities; The nature and timing of other pre -clinical a ctivities including in vitro and toxicology studies; The number of predecessor formulations and when each was founded that form the basis for the current formulation of RUT58 -60; When the new, unique hypochlorous acid -based formulations that were disclose d to Oculus’ intellectual property counsel in December 2012 were founded and how they relate to the formulations in the preceding bullet; The costs in terms of dollars and/or manpower associated with the discovery and formulation activities, separating the activities untaken by Oculus from those you undertook. In your response, separately tell us whether Oculus sponsored the initial clinical trials conducted by physicians in Mexico that demonstrated the faster tissue healing associated with hypochlorous acid products as disclosed on page 3. In addition tell us what information the Oculus Board of Directors reviewed when, in November 2012, it directed Oculus management to explore the idea of creating a wholly -owned subsidiary within which to pursue the de velopment of RUT58 -60. 3. We note that you are requesting confidential treatment for portions of Exhibit 10.4. Please be advised that we will review your request for confidential treatment once it is received and will provide any comments under separate cover. We will not be able to process any request for acceleration of the effective date of the pending registration statement until any such confidential treatment request is resolved. 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 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 you request acceleration of the effective date of the pending regist ration statement please provide a written s tatement 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; Hojabr Alimi Chief Executive Officer Ruthigen, Inc. August 23, 2013 Page 3 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 asse rt 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 registr ation statement. You may contact Ibolya Ignat at (202) 551 -3656 or Mark Brunhofer at (202) 551 -3638 if you have questions regarding comments on the financial statements and related matters. Please contact Amy Reischauer at (202) 551 -3793, Daniel Greenspan at (202) 551 -3623, or me at (202) 551-3715 with any other questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -Mail Ivan Blumenthal Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 666 Third Aven ue New York, NY 10017
2013-08-08 - CORRESP - Pulmatrix, Inc.
CORRESP
1
filename1.htm
Linda Rockett | 617 348
4888 | lrockett@mintz.com
One Financial Center
Boston, MA 02111
617-542-6000
617-542-2241 fax
www.mintz.com
August 8, 2013
Via EDGAR and by Federal Express
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 3561
Washington, D.C. 20549
Attention: Jeffrey Riedler, Assistant Director
Re: Ruthigen, Inc.
Confidential Draft Registration Statement on Form
S-1
Submitted May 24, 2013
CIK No. 0001574235
Ladies and Gentlemen:
We are submitting this letter on behalf
of Ruthigen, Inc. (the “Company”) in response to comments from the staff (the “Staff”) of
the Securities and Exchange Commission (the “Commission”) received by letter dated June 21, 2013 (the “Comment
Letter”) from Jeffrey P. Riedler, Assistant Director, to Hojabr Alimi, the Company’s Chief Executive Officer, relating
to the above-referenced registration statement on Form S-1 of the Company submitted with the Commission on May 24, 2013 on a confidential
basis pursuant to Title 1, Section 106 of the Jumpstart Our Business Startups Act (the “Confidential Submission”).
In conjunction with this letter, the Company is making its initial public filing (the “Initial Public Filing”)
of such registration statement and making further amendments thereto (as amended, the “Registration Statement”).
For convenient reference, we have set forth
below in italics each of the Staff’s comments set forth in the Comment Letter and have keyed the Company’s responses
to the numbering of the comments and the headings used in the Comment Letter. All of the responses are based on information provided
to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. by representatives of the Company. Where appropriate, the Company has responded
to the Staff’s comments by making changes to the disclosure in the Registration Statement as set forth in the Initial Public
Filing. Page numbers referred to in the responses reference the applicable pages of the Initial Public Filing.
We are providing by overnight delivery to
Daniel Greenspan of the Staff five courtesy copies of this letter and the Registration Statement that have been marked to show
changes from the initial filing of the Confidential Submission on May 24, 2013.
Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C.
Boston
| London | Los Angeles | New York | San Diego | San Francisco | Stamford | Washington
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
August 8, 2013
Page 2
General
1. Please submit all exhibits as soon as practicable. We may have further comments upon examination of these exhibits.
Response: The Company respectfully submits
that it has included additional exhibits to the Initial Public Filing, and will submit or file additional exhibits to the Registration
Statement as soon as practicable. The Company acknowledges that the Staff may have further comments upon examination of such exhibits.
2. We note that your draft registration statement includes the Representative’s warrants and the common stock underlying
those warrants as securities to be registered in this offering. Please be advised that the registration of the issuance of these
securities to the Representative, which are to be received by the Representative as underwriting compensation, does not entitle
the Representative to subsequently resell such securities to the public without additional registration. As an underwriter, the
Representative must avail itself of a resale registration statement or an applicable exemption from Section 5 of the Securities
Act of 1933 in order to sell the securities.
Response: The Company respectfully acknowledges
the Staff’s comment and has informed the Representative of the Staff’s comment.
3. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus.
If you will use any additional graphic, visual or photographic information in the printed prospectus, please provide us a proof
of each such item for our review prior to its use. Please note that we may have comments regarding this material.
Response: The Company respectfully submits
that it does not anticipate using any graphic, visual or photographic information, other than such information already included
in the Registration Statement. The Company will supplementally provide the Staff with copies of any additional graphic, visual
or photographic information used in the printed prospectus. The Company acknowledges that the Staff may have further comments upon
examination of such additional material.
4. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups
Act, please state your election under Section 107(b) of the JOBS Act:
· If you have elected to opt out of the extended transition period for complying with new or revised accounting standards
pursuant to Section 107(b), include a statement that the election is irrevocable; or
· If you have elected to use the extended transition period for complying with new or revised accounting standards under Section
102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards
that have different effective dates for public and private companies until those standards apply to private companies. Please state
in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply
with public company effective dates. Include a similar statement in your critical accounting policy disclosures.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
August 8, 2013
Page 3
In addition, please describe the extent to which
any of the exemptions available to emerging growth companies are also available to you as a Smaller Reporting Company.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 5-6, 29 and 38 of the Initial Public Filing.
5. 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. Similarly, please supplementally provide us with any research
reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section
105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering.
Response: As of the date of this response letter,
the Company has not relied upon the procedures available to emerging growth companies under Section 5(d) of the Securities Act
of 1933, as amended (the “Securities Act”). The Company will furnish any such material to the Staff in connection
with future correspondence, if the Company relies upon such section to provide material to qualified institutional buyers or institutional
accredited investors.
To date, no research reports about the Company have
been published or distributed in reliance on Section 2(a)(3) of the Securities Act by any broker or dealer that is participating
or will participate in the offering. The Company will supplementally provide the Staff with any such research reports should any
be published or distributed in reliance on Section 2(a)(3) of the Securities Act.
6. Please tell us what consideration you gave to presenting the historical results of the novel biotechnology business of Oculus
Innovative Sciences, Inc. in separate financial statements (i.e., carve-out financial statements) prior to your inception. It would
appear that presenting carve-out financial statements to include all relevant activities that have been part of the history of
your business, and that can be expected to repeat as the business continues in the future, is required. Separately reference for
us any authoritative literature you rely upon to support your position.
Response: The Company respectfully submits
the following response to the Staff:
We note the Staff’s observations relating to
the presentation of historical results of the novel biotechnology business of the Company’s parent, Oculus Innovative Sciences,
Inc. (“Oculus”), in separate financial statements (i.e., carve-out financial statements (SEC SAB Topic
1B.1)) prior to the Company’s inception. As described below, following the disclosure of RUT58-60 to Oculus’ intellectual
property counsel in December 2012, Oculus formed a wholly-owned subsidiary named Ruthigen, Inc., or the Company. In January 2013,
the Company was incorporated in the State of Nevada. Financial statements have been prepared for the Company reflecting all activities
of the business since formation. No direct or indirect product related costs were incurred by Oculus specifically relating to the
new formulation, RUT58-60, prior to this time period.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
August 8, 2013
Page 4
Such audited financial statements as of and for the
period ended March 31, 2013 have been included in the Registration Statement. No carve out financial statements for the period
prior to January 2013 are necessary since all direct or indirect product related costs incurred specifically relating to the new
formulation, RUT58-60, are already included within the historical financial statements of the Company for the period ended March
31, 2013.
The Company, a wholly-owned subsidiary of Oculus,
has submitted the Registration Statement to register shares being sold in a proposed initial
public offering of the Company. In connection with the filing of the Registration Statement, the Company is required to include
audited historical financial statements reflecting the operating activities of the Company. The Company
has executed a license and supply agreement with Oculus pursuant to which the Company will license from Oculus certain of
Oculus’ proprietary technology related to the use of hypochlorous acid for specific indications and territories as defined
in the license and supply agreement between the companies, effective upon the completion of the
proposed initial public offering.
The Company also executed a separation agreement with
Oculus to allow the Company to access the capital market and fund the development of the newly discovered RUT58-60 as a drug for
prevention of infection in abdominal surgery. This market is currently not available to Oculus and its technology due to both technological
and regulatory limitations.
Therefore, prior
to 2013, Oculus has not incurred any direct or indirect product costs with respect to the product candidate, RUT58-60, that the
Company intends to pursue or has developed. Based on the discussion presented below, audited
financial statements for the Company for the period from inception through March 31, 2013, represent the best available financial
information on the Company for the Registration Statement.
Information about Oculus
Innovative Sciences, Inc.
Oculus is the parent company of the Company. Oculus
is a global healthcare company that designs, manufactures and markets prescription and non-prescription products in over 20 countries.
Oculus is pioneering innovative products for the dermatology, surgical, advanced wound and tissue care,
and animal healthcare markets. Oculus’ primary focus is on the commercialization of its proprietary technology platform called
Microcyn® Technology but does not have the necessary regulatory approvals to market Microcyn® as a drug or as a medical
device with an antimicrobial or wound healing indication in the United States. To date, Oculus’
Microcyn-based products have received seven FDA 510(k) clearances in the United States. Many of these clearances are for use as
a medical device in wound cleaning, or debridement, lubricating, moistening and dressing, including traumatic, acute and chronic
wounds. Oculus’ products are cleared and marketed as a topical medical device for
patients suffering from open wounds and dermatological
indications in the United States. Oculus’ products are developed based on its proprietary
technology platform called Microcyn® Technology, a stable formulation of hypochlorous acid
cleared for topical use in the U.S. In the United States, Microcyn® is cleared by the United States Food and Drug Administration
(the “FDA”) as a medical device for the mechanical cleaning and debridement of wounds. Oculus’
advancement in invasive procedures has been hindered in the past by capital limitations and technological challenges to produce
a product as required for a drug approval by the FDA. Based on the directive given by the board of directors of Oculus in November
2012, Oculus’ management began investigating the idea of creating a wholly-owned subsidiary within which to pursue the development
of such a new drug.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
August 8, 2013
Page 5
Oculus does not have the necessary
capital to execute the required clinical trials for the newly discovered RUT58-60 or the regulatory approvals to
market such formulation as a drug or for invasive use in the United States, nor does Oculus have the clearance to market
Microcyn® with any therapeutic indications to include antimicrobial or wound healing claims
in the United States. Oculus has not developed a formulation approved by the FDA as a topical or an
invasive drug. Furthermore, the use of hypochlorous acid (HOCl) based products for use as a drug or during invasive procedures
shall require additional drug development activities as required by the FDA. The board of directors of Oculus has determined that
the best course of action is to fund drug development activities through its wholly-owned subsidiary, the Company.
Information about the Company
The Company was incorporated in Nevada on January
18, 2013 as a wholly-owned subsidiary of Oculus. The Company’s offices are located in Santa Rosa, California. The Company
is a development-stage biopharmaceutical company committed to the discovery, development, manufacture and commercialization of
RUT58-60, a pure form of hypochlorous acid-based solution with two to four times the concentration of HOCl as Microcyn® based
products manufactured by Oculus while expecting to meet the stringent drug requirements mandated by
the FDA, including, but not limited to, sterility, stability, safety and efficacy. In contrast
to Microcyn, the proposed drug candidate RUT58-60 contains stabilizers, including magnesium, and is intended for use during
invasive procedures with direct exposure to internal tissue and organs.
The proposed formulation development will be used for the prevention of infection associated with surgical and traumatic procedures.
The Company’s Principal
Product Candidate: RUT58-60
On
December 7, 2012, Oculus disclosed new, unique hypochlorous acid-based formulations to its intellectual property counsel. The formulations
formed the basis for the current RUT58-60 formulation. The RUT58-60 drug was first formulated by the Company in January
2013. This unique new drug candidate, RUT58-60, utilizes a unique method of manufacturing that is different
than what is used to manufacture Oculus’ products, and has a corresponding purified chemical active ingredient that
is more concentrated than Oculus’ Microcyn® Technology containing other elements, such as magnesium, to meet FDA’s
drug stability requirements. This formulation uses design elements that management believes will allow the product candidate to
be evaluated and reviewed as a biopharmaceutical agent, as opposed to a medical device.
No direct or indirect product related costs were incurred
by Oculus specifically relating to the new formulation, RUT58-60, prior to this time period.
Mintz, Levin
2013-06-24 - UPLOAD - Pulmatrix, Inc.
June 21 , 2013 Via E -Mail Hojabr Alimi Chief Executive Officer Ruthigen, Inc. 2455 Bennett Valley Road, Suite C116 Santa Rosa, CA Re: Ruthigen, Inc. Confidential Draft Registration Statement on Form S -1 Submitted May 24, 2013 CIK No. 0001574235 Dear Mr. Alimi : 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 circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in re sponse to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. General 1. Please submit all exhibits as soon as practicable. We may have further comments upon examination of these exhibits . 2. We note that your draft registration statement includes the Representative’s warrants and the common stock underlying those warrants as securities to be registered in this offering. Please be advised that the registration of the issuance of these securities to the Representative , which are to be received by the Representative as underwriting compensation, does not entitle the Representative to subsequently resell such securities to the public wit hout additional registration. As an underwriter, the Representative must avail itself of a resale registration statement or an applicable exemption from Section 5 of the Securities Ac t of 1933 in order to sell the securities. Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 2 3. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus. If you will use any additional graphic, visual or photographic inf ormation in the printed prospectus , please provide us a proof of each such item for our review prior to its use. Please note that we may have comments regarding this material. 4. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please s tate your election under Section 107(b) of the JOBS Act : If you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b), inclu de a statement that the election is irrevocable; or If you have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your fin ancial statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your critical accounting policy disclosures. In addition, please describe the extent to which any of the exemptions avail able to emerging growth companies are also available to you as a Smaller Reporting Company. 5. 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 s o 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. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering . 6. Please tell us what consideration you gave to presenting the historical results of the novel biotechnology business of Oculus Innovative Sciences, Inc. in separate financial statements (i.e., carve -out financial statements) pri or to your inception. It would appear that presenting carve -out financial statements to include all relevant activities that have been part of the history of your business, and that can be expected to repeat as the business continues in the future, is req uired. Separately reference for us any authoritative literature you rely upon to support your position. Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 3 7. It appears that you are required to disclose unaudited pro forma financial information in accordance with Article 11 of Regulation S -X to reflect the effect of the transactions that have been or will be completed prior to or concurrently with the closing o f your offering on your historical financial statements and to combine any carve -out financial statements of your predecessor operations. In your next amendment please include unaudited pro forma financial information to give effect to your offering, to p resent the continuing impact of the series of transactions that will take effect upon the completion of your offering and to combine your predecessor carve -out financial information or tell us why including such pro forma financial information is considere d not required. Prospectus Summary, page 2 8. Please expand the opening paragraph of your Prospectus Summary under “Overview” to make clear that you are a development company with no approved product s and, immediately prior to the offering, have been a wholly -owned subsidiary of Oculus that was formed in January 2013. 9. We note your statement on page 2 , and beginn ing on page 43 in the “Business” section, that you believe RUT58 -60 will be able to meet the safety and efficacy standards that the FDA require s for the approval of a new dru g. Please expand this disclosure to make clear that the process to obtain FDA approval can be unpredictable and can take several years, and that you cannot guarantee that your product candidate will ever obtain such approval. 10. We note your statements on page 3 , and on page 44 in the “Business” section, regarding the safety, tolerability and broad -range antimicrobial poten cy of RUT58 -06, and that it does not appear to promote resistance to bacteria. Please expand your disclosure to make clear that conclusions are based on preclinical trials only. 11. We note your statement on page 3 regarding your discussions with pharmaceuti cal companies regarding partnership and collaboration activities. Please expand this disclosure to make clear, if true, that you have no such arrangements in place and that you cannot guarantee that you will be able to secure any such arrangement. Risks Relating to Our Business, page 5 12. Please combine the first and fifth bullet points , as they appear to be redundant. 13. Please expand your summary of risk factor s in this section to include the risks relating to: Oculus’s control of a significant portion of your outstanding common stock after the transaction; The potential conflict (s) of interest given that your directors will serve simultaneously as directors o f Oculus and that your chief executive officer and directors hold Oculus common stock and rights to purchase Oculus common stock ; Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 4 the risks you will face as a standalone public company that you did not face as a wholly owned subsidiary of Oculus; and the anticipated benefits of the Separation and the Distribution that you and/or your stockholders may not achieve. “We are a development stage company with no commercial products.” page 9 “We are heavily dependent on the success of our lead drug candidate…” page 9 “We have limited knowledge and experience with NDA studies…” page 11 14. Please expand each of these risk factor s to disclose that you have not yet submitted an IND to the FDA in order to begin clinical trials for RUT58 -60. “We may be unable to maintain sufficient product liability insurance.” page 13 15. Please d escribe briefly the circumstances under which you may need to obtain additional coverage under the supply agreement and, when you enter into independent insurance plan, please quantify your insurance coverage . “We may not be able to attract, retain, or manage highly qualified personnel…” page 15 16. Please expand this risk factor to identify any key employees other than your two executive officers. “We expect to face competition, often from companies with greater resources…” page 1 9 17. Please expand this risk factor to identify your anticipated competitors. “We expect that we may need additional funding to advance our clinical trial…” page 21 18. Please revise this risk factor to disclose the quarter through which you believe your available fu nds following the offering will be sufficient to fund your operations . We no te the disclosure in your Use of Proceeds on page 33 that you intend to use the net proceeds from the offering, in part, to initiate your first pivotal trial, yet on page 21 you state that such funds will not be sufficient to conduct your pivotal trials. Please clarify this apparent discrepancy. “Your investment in our common stock may be adversely affected if Oculus…” page 25 19. Please combine this risk factor with the risk factor captioned “The Distribution may not occur” on page 27, as they appear to describe the same risk(s). Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 5 “Oculus may not distribute our shares it holds to its stockholders…” page 26 20. Please combine this risk factor with the risk factor captioned “We may be unable to achieve some or all of the benefits…” on page 27, as they appear to describe the same risk(s). “The assets and reso urces that we acquire from Oculus…” page 27 21. Please expand this risk factor to disclose any material assets or resources , other than those which you will receive from Oculus in the Separation, that you have identified that you will need to operate as a st and-alone company . “Financi al reporting obligations of being a public company…” page 30 22. Please combine this risk factor with the risk factor captioned “Our management will be required to devote…” on page 30, as they appear to describe the same risk(s). Industry and Market Data , page 32 23. Please note that it is not appropriate to state or imply that you do not have liability for the statements in your registration statement. Your statements that you have not independently verified third part data and that the results and estimates fr om your internal research have not been verified by any independent source could imply th at you are not taking liability for this information. In order to eliminate any inference that you are not liable for all of the information in your registration stat ement, please delete these statements or include a statement s pecifically accepting liability for these statements. Use of Pr oceeds , page 33 24. Please expand your disclosure regarding your u se of proceeds to provide the estimated amount of proceeds to be used for each of the planned Phase 1/2 clinical trial; initiation of the first pivotal trial; the establishment and validation of your manufacturing facility; and the milestone payments und er your license and supply agreement. Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 6 Management’s Discussion and Analysis of Financial Condition and Results of Operations JOBS Act, page 39 25. Although you mention the extended transition period provided in Securities Act Sect ion 7(a)(2)(B) for complying with new or revised accounting standards, it is unclear whether you are opting out of this provision. Please revise your disclosure to clarify. To the extent you wish to follow the extended transition period permitted under t he Securities Act, please revise your disclosure here and in a risk factor to highlight that in the future your financial statements may not be comparable to those of other public companies. To the extent you opt out of the extended transition period, ple ase revise your disclosure to indicate that this election is irrevocable. Please see Questions 13 and 37 of the Jumpstart Our Business Startups Act Frequently Asked Questions. Research and Development, page 40 26. We noted a statement made during Oculus Inn ovative Sciences’ third quarter 2013 earnings call that your parent’s plan is to shift the burden of its high -expense RUT58 -60 drug development program to Ruthigen. Please include disclosure about the estimated future expenses related to the development of RUT58 -60. To the extent that this information is not estimable, disclose that fact an d the reason why it is not estimable . To the extent that at least some portion of future development expenses was estimated to support the size of your offering in di scussions with your underwriters, please disclose those estimates clarifying which specific future expenses are included in your disclosure. Please note that you may inform potential investors that the amounts you disclose are estimates and that those est imates are subject to revision and the reasons therefor. Liquidity and Capital Resources, page 40 27. Please include a discussion of the cash advances and direct payments made by your parent subsequent to March 31, 2013 as applicable. Contractual Obligations, page 41 28. Please include a discussion that quantifies the potential milestone payments to Oculus that have been omitted from a contractual obligations table and disclose the events that would trigger these payments. Please confirm to us that a ll of your payment obligations under your collaboration agreements with Oculus and / or with other parties have been disclosed in this section as appropriate. Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 7 Operating Capital and Capital Expenditure requirements, page 41 29. Although you disclose on page 67 that you have no equity awards outstanding at March 31, 2013, please include an itemized chronological schedule covering any equity instruments that have been or will be issued prior to or concurrently with the closing of your offering (including stock units, options, warrants, etc.) and include the following information separately for each equity instrument issuance: The date of the transaction; The number of equity instruments issued or options granted; The exercise price of equity instruments grante d if applicable; The fair value of the common stock on each grate date and how the fair value was determined; Whether or not the valuation used to determine the fair value of the equity instruments was contemporaneous or retrospective ; and, If the valuat ion specialist was a related party, please state that fact . After your estimated IPO price range has been disclosed, d iscuss each significant factor contributing to the difference between the fair value as of the date of each date of issuance and the esti mated IPO price . Please continue to update your disclosures for any grants or equity issuances up until the time of effectiveness of your registration statement. Please note that once your filing include s an estimated offering price we may have further comments. Business , page 43 Select Pathoge n Activity of RUT58 -60, page 49 30. This section contains several technical or other terms that are not defined or explained. Please explain the meaning and significance of the following terms the first time you use them: Biocompatibility ; Logs and log reduc tion; Full biological activity ; and Serial dilutions Hojabr Alimi Ruthigen, Inc. June 2 1, 2013 Page 8 Market Opportunity, page 51 31.