CORRESP Filing
Pulmatrix, Inc.
Date: April 17, 2025 · CIK: 0001574235 · Accession: 0001641172-25-005167
AI Filing Summary & Sentiment
File numbers found in text: 333-284993
Referenced dates: March 14, 2025
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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