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Vyome Holdings, Inc
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2024-11-01
Vyome Holdings, Inc
Summary
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Company responded
2024-12-05
Vyome Holdings, Inc
Summary
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Company responded
2025-01-14
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
1 company response(s)
Medium - date proximity
↓
Vyome Holdings, Inc
Awaiting Response
0 company response(s)
High
Vyome Holdings, Inc
Awaiting Response
0 company response(s)
High
Vyome Holdings, Inc
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2025-02-12
Vyome Holdings, Inc
Summary
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Company responded
2025-02-13
Vyome Holdings, Inc
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Company responded
2025-02-14
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2025-01-03
Vyome Holdings, Inc
Summary
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Company responded
2025-01-14
Vyome Holdings, Inc
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Company responded
2025-02-12
Vyome Holdings, Inc
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Vyome Holdings, Inc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2025-01-31
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-12-20
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-08-30
Vyome Holdings, Inc
Summary
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Company responded
2023-09-28
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2023-01-20
Vyome Holdings, Inc
Summary
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Company responded
2023-02-01
Vyome Holdings, Inc
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2023-02-01
Vyome Holdings, Inc
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2023-02-03
Vyome Holdings, Inc
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2023-02-03
Vyome Holdings, Inc
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Vyome Holdings, Inc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-09-10
Vyome Holdings, Inc
Summary
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Company responded
2021-09-15
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2021-04-09
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-02-14
Vyome Holdings, Inc
Summary
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Company responded
2020-02-27
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2019-07-16
Vyome Holdings, Inc
Summary
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Company responded
2019-07-17
Vyome Holdings, Inc
References: July 16, 2019
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Company responded
2019-07-30
Vyome Holdings, Inc
Summary
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2019-07-30
Vyome Holdings, Inc
Summary
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Company responded
2019-08-01
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-08-01
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-02-08
Vyome Holdings, Inc
Summary
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Company responded
2019-02-11
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2018-09-11
Vyome Holdings, Inc
Summary
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Company responded
2018-09-12
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2017-11-14
Vyome Holdings, Inc
Summary
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Company responded
2017-11-17
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2016-09-20
Vyome Holdings, Inc
Summary
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Company responded
2016-09-26
Vyome Holdings, Inc
References: September 20, 2016
Summary
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Company responded
2016-10-03
Vyome Holdings, Inc
Summary
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Company responded
2016-10-03
Vyome Holdings, Inc
Summary
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Vyome Holdings, Inc
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2016-08-31
Vyome Holdings, Inc
Summary
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Company responded
2016-09-08
Vyome Holdings, Inc
References: August 31, 2016
Summary
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Company responded
2016-09-16
Vyome Holdings, Inc
References: August 31, 2016
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-14 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-05-13 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-05-07 | SEC Comment Letter | Vyome Holdings, Inc | DE | 377-07967 | Read Filing View |
| 2025-04-28 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-03-14 | SEC Comment Letter | Vyome Holdings, Inc | DE | 001-37897 | Read Filing View |
| 2025-03-13 | SEC Comment Letter | Vyome Holdings, Inc | DE | 001-37897 | Read Filing View |
| 2025-02-14 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-02-13 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-02-12 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-02-12 | SEC Comment Letter | Vyome Holdings, Inc | DE | 333-284362 | Read Filing View |
| 2025-01-31 | SEC Comment Letter | Vyome Holdings, Inc | DE | 333-282459 | Read Filing View |
| 2025-01-14 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-01-14 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-01-03 | SEC Comment Letter | Vyome Holdings, Inc | DE | 333-283952 | Read Filing View |
| 2024-12-20 | SEC Comment Letter | Vyome Holdings, Inc | DE | 333-282459 | Read Filing View |
| 2024-12-05 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2024-11-01 | SEC Comment Letter | Vyome Holdings, Inc | DE | 333-282459 | Read Filing View |
| 2023-09-28 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-08-30 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-02-03 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-02-03 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-02-01 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-02-01 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-01-20 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2021-09-15 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2021-09-10 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2021-04-09 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2020-02-27 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2020-02-14 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-08-01 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-08-01 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-07-30 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-07-30 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-07-17 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-07-16 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-02-11 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2018-09-12 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2018-09-11 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2017-11-17 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2017-11-14 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-10-03 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-10-03 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-09-26 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-09-20 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-09-16 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-09-08 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-08-31 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-07 | SEC Comment Letter | Vyome Holdings, Inc | DE | 377-07967 | Read Filing View |
| 2025-03-14 | SEC Comment Letter | Vyome Holdings, Inc | DE | 001-37897 | Read Filing View |
| 2025-03-13 | SEC Comment Letter | Vyome Holdings, Inc | DE | 001-37897 | Read Filing View |
| 2025-02-12 | SEC Comment Letter | Vyome Holdings, Inc | DE | 333-284362 | Read Filing View |
| 2025-01-31 | SEC Comment Letter | Vyome Holdings, Inc | DE | 333-282459 | Read Filing View |
| 2025-01-03 | SEC Comment Letter | Vyome Holdings, Inc | DE | 333-283952 | Read Filing View |
| 2024-12-20 | SEC Comment Letter | Vyome Holdings, Inc | DE | 333-282459 | Read Filing View |
| 2024-11-01 | SEC Comment Letter | Vyome Holdings, Inc | DE | 333-282459 | Read Filing View |
| 2023-08-30 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-01-20 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2021-09-10 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2020-02-14 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-08-01 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-07-16 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2018-09-11 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2017-11-14 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-09-20 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-08-31 | SEC Comment Letter | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-14 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-05-13 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-04-28 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-02-14 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-02-13 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-02-12 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-01-14 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2025-01-14 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2024-12-05 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-09-28 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-02-03 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-02-03 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-02-01 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2023-02-01 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2021-09-15 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2021-04-09 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2020-02-27 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-08-01 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-07-30 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-07-30 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-07-17 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2019-02-11 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2018-09-12 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2017-11-17 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-10-03 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-10-03 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-09-26 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-09-16 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
| 2016-09-08 | Company Response | Vyome Holdings, Inc | DE | N/A | Read Filing View |
2025-05-14 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm May 14, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attn: Doris Stacey Gama Re: ReShape Lifesciences Inc. Registration Statement on Form S-4, as amended File No. 333-282459 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, ReShape Lifesciences Inc. (the "Registrant") hereby respectfully requests that the effective date of the above-referenced registration statement be accelerated so that it will be declared effective at 4:01 p.m., Eastern Time, on May 14, 2025, or as soon thereafter as is practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Fox Rothschild LLP, counsel to the Registrant, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Brett Hanson of Fox Rothschild LLP at (612) 607-7330. Thank you for your assistance in this matter. Should you have any questions, please call Mr. Hanson. Very truly yours, /s/ Paul F. Hickey Paul F. Hickey Chief Executive Officer
2025-05-13 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm May 13, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attn: Doris Stacey Gama Re: ReShape Lifesciences Inc. Registration Statement on Form S-3 File No. 333-287168 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, ReShape Lifesciences Inc. (the "Registrant") hereby respectfully requests that the effective date of the above-referenced registration statement be accelerated so that it will be declared effective at 4:01 p.m., Eastern Time, on May 14, 2025, or as soon thereafter as is practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Fox Rothschild LLP, counsel to the Registrant, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Brett Hanson of Fox Rothschild LLP at (612) 607-7330. Thank you for your assistance in this matter. Should you have any questions, please call Mr. Hanson. Very truly yours, /s/ Paul F. Hickey Paul F. Hickey Chief Executive Officer
2025-05-07 - UPLOAD - Vyome Holdings, Inc File: 377-07967
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 7, 2025 Paul F. Hickey Chief Executive Officer ReShape Lifesciences Inc. 18 Technology Dr., Suite 110 Irvine, CA 92618 Re: ReShape Lifesciences Inc. Draft Registration Statement on Form S-3 Submitted May 2, 2025 CIK No. 0001427570 Dear Paul F. Hickey: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days prior to the requested effective date and time. 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 Doris Stacey Gama at 202-551-3188 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Brett Hanson, Esq. </TEXT> </DOCUMENT>
2025-04-28 - CORRESP - Vyome Holdings, Inc
CORRESP
1
filename1.htm
April 28, 2025
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn: Gary Newberry, Mary Mast, Doris Stacey Gama and Joe McCann
Re: ReShape Lifesciences Inc.
Amendment No. 2 to Registration
Statement on Form S-4
Filed January 14, 2025
File No. 333-282459
Ladies and Gentlemen:
ReShape Lifesciences Inc. (the " Company ," " ReShape ,"
" we ," or " our ") is submitting this letter in response to comments from the staff (the " Staff ")
of the Securities and Exchange Commission (the " Commission ") received by electronic mail dated January 31, 2025,
relating to the Amendment No. 2 to Registration Statement on Form S-4 filed January 14, 2025 by the Company (the " Registration
Statement "). Amendment No. 3 to the Registration Statement (" Amendment No. 3 ") is being submitted
via EDGAR concurrently herewith responding to the Staff's comments and including certain other revisions and updates. The numbered
paragraphs below correspond to the numbered comments in the Staff's letter, and the Staff's comments are presented in italics.
Page numbers in the text of the Company's responses correspond
to page numbers in Amendment No. 3. Please note that capitalized terms used but not otherwise defined in this letter have the
meanings ascribed to such terms in Amendment No. 3.
Our responses are as follows:
Amendment No. 2 to Registration Statement on Form S-4
Certain U.S. Federal Income Tax Consequences, page 140
1. We refer to the short-form opinion filed as Exhibit 8.2. Please revise to indicate that the disclosure in the prospectus regarding
the U.S. federal income tax consequences of the Merger or Asset Sale to U.S. Holders of ReShape Shares represents the opinion of Fox Rothschild
LLP. For guidance regarding short-form tax opinions, please refer to Staff Legal Bulletin No. 19 (Oct. 14, 2011).
In response to the Staff's comment, the Company has revised the
disclosure on page 141 of Amendment No. 3 and filed an updated opinion of Fox Rothschild LLP as Exhibit 8.2.
2. With reference to page 3 of the long-form tax opinion filed as Exhibit 8.1, please revise the prospectus disclosure on
pages 21, 101, and 141 to clarify that it is the opinion of Sichenzia Ross Ference Carmel LLP ("SRFC") that the Exchange
will be treated as a reorganization under Code section 368(a)(1)(a) and that under Code section 354 of the Code no gain or loss will
be recognized by the U.S. Holders of Vyome stock as a result of the Merger. Also disclose that SRFC's tax opinion is presented in
Exhibit 8.1 to the registration statement. For guidance regarding longform tax opinions, please refer to Staff Legal Bulletin No. 19
(Oct. 14, 2011).
Because of the economic substance issue arising under the Section 368(a)(1) reorganization
(from the issuance of Vyome India shares), an issue which is addressed extensively in the opinion, SRFC cannot, without some elaboration,
make the definitive statements requested by the SEC on pages 21 and 102. Accordingly, the discussion on pages 21 and 102 (and
on page 141) recites that (i) it is SRFC's opinion that the Merger qualifies under Section 368(a)(1) and is
tax free under Section 354 and (ii) the opinion is based on the favorable resolution of the economic substance issue and it
is SRFC's opinion that that issue is also resolved favorably.
Vyome's Executive Compensation, page 210
3. Please provide executive compensation information, where applicable, for the fiscal year ended 12/31/2024 for both Vyome and ReShape.
In response to the Staff's comment, the Company has updated the
disclosure beginning on page 236 regarding ReShape's executive compensation and the disclosure beginning on page 245 regarding
Vyome's executive compensation for the fiscal year ended 12/31/2024.
* * * * *
Thank you for your review of the submissions. If you should have any
questions regarding the response letter, please do not hesitate to contact the Company's outside legal counsel, Brett Hanson of
Fox Rothschild LLP, at (612) 607-7330.
Sincerely,
/s/ Paul Hickey
Paul Hickey
cc: Brett Hanson, Fox Rothschild LLP
2025-03-14 - UPLOAD - Vyome Holdings, Inc File: 001-37897
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 14, 2025 Paul Hickey President and Chief Executive Officer ReShape Lifesciences Inc. 8 Technology Drive, Suite 110 Irvine, CA 92618 Re: ReShape Lifesciences Inc. Preliminary Proxy Statement on Schedule 14A Filed March 3, 2025 File No. 001-37897 Dear Paul Hickey: 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, Division of Corporation Finance Office of Life Sciences cc: Brett Hanson, Esq. </TEXT> </DOCUMENT>
2025-03-13 - UPLOAD - Vyome Holdings, Inc File: 001-37897
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 13, 2025 Paul Hickey President and Chief Executive Officer ReShape Lifesciences Inc. 8 Technology Drive, Suite 110 Irvine, CA 92618 Re: ReShape Lifesciences Inc. Preliminary Proxy Statement on Schedule 14A Filed March 3, 2025 File No. 001-37897 Dear Paul Hickey: We have reviewed your filing and have the following comments. Please respond to this letter 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 a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Preliminary Proxy Statement on Schedule 14A General 1. We note your references in your preliminary proxy statement to an "alternative cashless exercise" of the Warrants. The term "cashless exercise" is generally understood to allow a warrant holder to exercise a warrant without paying cash for the exercise price and reducing the number of shares receivable by the holder by an amount equal in value to the aggregate exercise price the holder would otherwise pay to exercise the warrant(s). In cashless exercises, it is expected that the warrant holder receives fewer shares than they would if they opted to pay the exercise price in cash. Please clarify your disclosure throughout by revising the references to "alternative cashless exercise" and exclusively using the term "zero exercise price" or another appropriate term that conveys that, in addition to the company receiving no cash upon the "alternative cashless exercise," the warrant holders would be entitled to receive more shares than they would under the cash exercise terms. 2. We note your disclosure on page 13 that you are seeking stockholder approval for the issuance of up to 15,132,975 shares of common stock upon the exercise of up to March 13, 2025 Page 2 2,703,862 warrants to purchase common stock. In each instance in your proxy statement where you describe Proposal 2, which is asking stockholders to approve the exercisability of the common stock purchase warrants, and the issuance of the common stock underlying such warrants, please clarify that the proposal seeks stockholder approval of up to 15,132,975 shares of common stock upon the exercise of up to 2,703,862 warrants to purchase common stock, which may be exercised under a provision with no exercise price. 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 Tim Buchmiller at 202-551-3635 or Suzanne Hayes at 202-551-3675 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Brett Hanson, Esq. </TEXT> </DOCUMENT>
2025-02-14 - CORRESP - Vyome Holdings, Inc
CORRESP
1
filename1.htm
February 14, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
ReShape Lifesciences Inc.
Registration Statement on Form S-1
File No. 333-284362
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, Maxim Group LLC (“Maxim”),
as placement agent, hereby concurs in the request by ReShape Lifesciences Inc. that the effective date of the above-referenced Registration
Statement be accelerated to 4:00 PM, Eastern Time, on Friday, February 14, 2025, or as soon thereafter as may be practicable.
Maxim affirms that it is aware
of its obligations under the Securities Act in connection with this offering.
Very truly yours,
Maxim Group LLC
By:
/s/ Ritesh
Veera
Name: Ritesh Veera
Title: Co-Head of Investment Banking
2025-02-13 - CORRESP - Vyome Holdings, Inc
CORRESP
1
filename1.htm
February 13, 2025
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Attn: Doris Stacey Gama
Re:
ReShape Lifesciences Inc.
Registration Statement on Form S-1
File No. 333-284362
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended,
ReShape Lifesciences Inc. (the “Registrant”) hereby respectfully requests 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 February 14, 2025, or
as soon thereafter as is practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to
the staff of the Commission. The Registrant hereby authorizes Fox Rothschild LLP, counsel to the Registrant, to orally modify or withdraw
this request for acceleration.
The Registrant requests that it be notified of such effectiveness by
a telephone call to Brett Hanson of Fox Rothschild LLP at (612) 607-7330.
Thank you for your assistance in this matter. Should you have any questions,
please call Mr. Hanson.
Very truly yours,
/s/ Paul F. Hickey
Paul F. Hickey
Chief Executive Officer
2025-02-12 - CORRESP - Vyome Holdings, Inc
CORRESP
1
filename1.htm
February 12, 2025
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Attn: Doris Stacey Gama
Re:
ReShape Lifesciences Inc.
Registration Statement on Form S-1
File No. 333-283952
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended,
ReShape Lifesciences Inc. (the “Registrant”) hereby respectfully requests 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 February 14, 2025, or
as soon thereafter as is practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to
the staff of the Commission. The Registrant hereby authorizes Fox Rothschild LLP, counsel to the Registrant, to orally modify or withdraw
this request for acceleration.
The Registrant requests that it be notified of such effectiveness by
a telephone call to Brett Hanson of Fox Rothschild LLP at (612) 607-7330.
Thank you for your assistance in this matter. Should you have any questions,
please call Mr. Hanson.
Very truly yours,
/s/ Paul F. Hickey
Paul F. Hickey
Chief Executive Officer
2025-02-12 - UPLOAD - Vyome Holdings, Inc File: 333-284362
February 12, 2025
Paul F. Hickey
Chief Executive Officer
ReShape Lifesciences Inc.
18 Technology Dr, Suite 110
Irvine, CA 92618
Re:ReShape Lifesciences Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed February 6, 2025
File No. 333-284362
Dear Paul F. Hickey:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments.
Amendment No. 1 to Registration Statement on Form S-1
Coverpage
1.Please revise the cover page to highlight that the warrants will not be exercisable at
closing and that there is a risk that the warrants could expire worthless if shareholder
approval is not obtained in the future.
We note that your revised disclosure indicates that you have added an "alternative
cashless exercise option." Based on your disclosures on pages 47-48 it appears that
each warrant could be exercised for 1.2 common shares on a cashless basis rather than
for one share on a cash basis. Accordingly, please revise the prospectus header to
reflect, if true, that you are offering up to 1,591,512 shares of common stock
underlying the Warrants rather than 1,326,260 shares. Also highlight that the
“alternative cashless exercise” provision would allow a warrant holder to receive 1.2
shares of common stock without the holder having to make any exercise payment. 2.
February 12, 2025
Page 2
Explain that as a result you do not expect to receive any cash proceeds from the
exercise of the Warrants because, if true, it is highly unlikely that a warrant holder
would wish to pay an exercise price in cash to receive one share when they could
choose the alternative cashless exercise option and pay no money to receive 1.2
shares.
Please contact Doris Stacey Gama at 202-551-3188 or Joe McCann at 202-551-6262
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Brett Hanson, Esq.
2025-01-31 - UPLOAD - Vyome Holdings, Inc File: 333-282459
January 31, 2025
Paul Hickey
President and Chief Executive Officer
ReShape Lifesciences Inc.
18 Technology Dr., Suite 110
Irvine, CA 92618
Re:ReShape Lifesciences Inc.
Amendment No. 2 to Registration Statement on Form S-4
Filed January 14, 2025
File No. 333-282459
Dear Paul Hickey:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our December 20, 2024
letter.
Amendment No. 2 to Registration Statement on Form S-4
Certain U.S. Federal Income Tax Consequences, page 140
1.We refer to the short-form opinion filed as Exhibit 8.2. Please revise to indicate that
the disclosure in the prospectus regarding the U.S. federal income tax consequences of
the Merger or Asset Sale to U.S. Holders of ReShape Shares represents the opinion of
Fox Rothschild LLP. For guidance regarding short-form tax opinions, please refer to
Staff Legal Bulletin No. 19 (Oct. 14, 2011).
With reference to page 3 of the long-form tax opinion filed as Exhibit 8.1, please
revise the prospectus disclosure on pages 21, 101, and 141 to clarify that it is the
opinion of Sichenzia Ross Ference Carmel LLP (“SRFC”) that the Exchange will be
treated as a reorganization under Code section 368(a)(1)(a) and that under Code 2.
January 31, 2025
Page 2
section 354 of the Code no gain or loss will be recognized by the U.S. Holders of
Vyome stock as a result of the Merger. Also disclose that SRFC’s tax opinion is
presented in Exhibit 8.1 to the registration statement. For guidance regarding long-
form tax opinions, please refer to Staff Legal Bulletin No. 19 (Oct. 14, 2011).
Vyome's Executive Compensation, page 210
3.Please provide executive compensation information, where applicable, for the fiscal
year ended 12/31/2024 for both Vyome and ReShape.
Please contact Gary Newberry at 202-551-3761 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Doris Stacey Gama at 202-551-3188 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Brett Hanson, Esq.
2025-01-14 - CORRESP - Vyome Holdings, Inc
CORRESP
1
filename1.htm
January 14, 2025
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn: Gary Newberry, Mary Mast, Doris Stacey Gama and Joe McCann
Re: ReShape Lifesciences Inc.
Amendment No. 1 to Registration Statement
on Form S-4
Filed December 6, 2024
File No. 333-282459
Ladies and Gentlemen:
ReShape Lifesciences Inc. (the “Company,” “ReShape,”
“we,” or “our”) is submitting this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) received by electronic mail dated December 20, 2024,
relating to the Amendment No. 1 to Registration Statement on Form S-4 filed December 6, 2024 by the Company (the “Registration
Statement”). Amendment No. 2 to the Registration Statement (“Amendment No. 2”) is being submitted
via EDGAR concurrently herewith responding to the Staff’s comments and including certain other revisions and updates. The numbered
paragraphs below correspond to the numbered comments in the Staff’s letter, and the Staff’s comments are presented in italics.
Page numbers in the text of the Company’s responses correspond
to page numbers in Amendment No. 2. Please note that capitalized terms used but not otherwise defined in this letter have the
meanings ascribed to such terms in Amendment No. 2.
Our responses are as follows:
Amendment No. 1 to Registration Statement on Form S-4
Cover Page
1. We refer to prior comment 2. With reference to the disclosure on page 14, please revise the prospectus coverpage to highlight
the equity percentage range (between 88.9% and 92.31%).
In response to the Staff’s comment, the Company has revised the
disclosure on the cover page of Amendment No. 2 and has conformed all other references accordingly.
Q: What is the proposed Asset Sale?, page 1
2. We note your response to prior comment 16. Please revise the Q&A to explain that ReShape expects to use substantially all of
the proceeds it received from the Asset Sale to pay transaction expenses related to the Merger and Asset Sale and ordinary course accounts
payable. Similarly, revise the disclosure on page 118 concerning Maxim’s valuation analysis to clarify why ReShape expects
to only having $1.5 million in cash as opposed to $5.16 million or more at closing.
In response to the Staff’s comment, the Company has revised the
disclosure on page 1 and page 132 of Amendment No. 2.
Q. What are the put-call option agreements to be entered into
with certain stockholders of Vyome and Vyome India…, page 2
3. We note your revised disclosure in response to prior comment 3. Revise the disclosure at the bottom of page 2 to explain the
“certain price” relating to the combined company’s call option. We also note that your beneficial ownership table on
page 267 indicates that the two affiliated Navam entities hold approximately half of the entitled shares (751,147). Please tell us
whether any other Directors, Officers or 5% holders beneficially own entitled shares that are subject to the put-call option agreement,
including shares underlying options.
In response to the Staff’s comment, the Company has revised the
disclosure on page 3 of Amendment No. 2 to substitute the reference from “certain price” to the exchange ratio
at which all Vyome shareholders would be receiving ReShape shares at. Further, details of directors, officers or 5% holders that beneficially
own entitled shares which are subject to the put-call option agreement have been provided below. Disclosures under the referenced Q&A
for the put-call option agreement and under the section “Security Ownership of Certain Beneficial Owners and Management of the Combined
Company” have also been amended to clarify the same:
Name of Holder
Shares in the Combined Company
subject to put-call option agreement,
including shares underlying options
Venkat Nelabhotla
8
Rajeev Mantri
1
Mohanjit Jolly (through his affiliation with Iron Pillar India Fund I)
180,568
Navam Capital Private Limited
627,573
Navam Biotech Ventures
123,674
The Merger
Background of Merger, page 105
4. We note your response to prior comment 12. Please revise the January 23 entry to disclose the merger consideration and the
plans for ReShape’s business assets.
In response to the Staff’s comment, the Company has revised the
disclosure on page 118 of Amendment No. 2.
Opinion of ReShape’s Financial Advisor – Maxim Group
LLC, page 115
5. We note your response to prior comment 15. We also note that your disclosure continues to state that the Maxim opinion “was
not prepared for ReShape’s stockholders or any other person or entity, nor will it grant them any rights or remedies.” Please
remove this statement or disclose the basis for Maxim’s belief that shareholders cannot rely on the opinion to support any claims
against Maxim arising under applicable state law (e.g., the inclusion of an express disclaimer in Maxim’s engagement letter with
the company). Describe any applicable state-law authority regarding the availability of such a potential defense. In the absence of applicable
state-law authority, disclose that the availability of such a defense will be resolved by a court of competent jurisdiction. Also disclose
that resolution of the question of the availability of such a defense will have no effect on the rights and responsibilities of the board
of directors under applicable state law. Further disclose that the availability of such a state-law defense to Maxim would have no effect
on the rights and responsibilities of either Maxim or the board of directors under the federal securities laws.
In response to the Staff’s comment, the Company has revised the
disclosure on page 128 of Amendment No. 2.
Certain U.S. Federal Income Tax Consequences, page 126
6. With reference to prior comment 21, we note the revised disclosure on page 126 stating that there are no U.S. federal income
tax consequences of the Merger or Asset Sale to U.S. Holders of ReShape Shares. Please revise to provide a tax opinion regarding these
tax matters and consequences to the ReShape shareholders. Refer to Regulation S-K, Item 601(b)(8).
In response to the Staff’s comment, the Company will provide
the tax opinion of Fox Rothschild LLP as Exhibit 8.2.
U.S. Federal Income Tax Consequences of the Merger to U.S. Holders
of Vyome Shares, page 128
7. With reference to Exhibit 8.1, please revise to disclose that the disclosure in the section constitutes the opinion of Sichenzia
Ross Ference Carmel LLP, or advise.
In response to the Staff’s comment, the Company would like to
advise that the disclosure in the section “Reorganization” recites that it reflects the opinion of Sichenzia Ross Ference
Carmel LLP, but the disclosure does not constitute the actual opinion of Sichenzia Ross Ference Carmel LLP. The actual opinion of Sichenzia
Ross Ference Carmel LLP, which is not a short-form opinion but a full opinion, will be attached as Exhibit 8.1 to the amended registration
statement.
The Company has also revised the disclosure in the section “Section 351
transaction” to clarify that the disclosure reflects the opinion of Sichenzia Ross Ference Carmel LLC. However, as in the case of
the disclosure in “Reorganization” (above), the disclosure under the section “Section 351 transaction” does
not itself constitute the actual opinion of Sichenzia Ross Ference Carmel LLP (which is a full opinion attached to Exhibit 8.1).
Our Programs, page 171
8. We note your statement that the active agent in VT-1953 is approved by the US-FDA (NDA#22-308) as an eye drop for the treatment
of bacterial conjunctivitis. We note that NDA#22-308 approved the drug Besivance for the treatment of bacterial conjunctivitis. An FDA
approval is for the drug as a whole for a specific indication and not for a specific ingredient used in the formulation. As such, please
revise the statement that the active agent in VT-1953 is approved by the US-FDA.
In response to the Staff’s comment, the Company has revised the
disclosure on page 187 of Amendment No. 2 to clarify that an eye drop with the same active agent as in VT-1953 is approved
by the US- FDA (NDA#22-308) for the treatment of bacterial conjunctivitis.
9. We note your revised disclosure in response to prior comment 24. Please remove the disclosure indicating that mycophenolate has
been reported to be “clinically effective in unveitis.” To the extent that you include the quotations from the published third
party studies, please provide context by disclosing in the same paragraph, if true, that FDA has not approved mycophenolate or mycophenolate
sodium to treat patients with uveitis and that FDA would need to review clinical trial data in order to determine that these drugs were
safe and effective to treat uveitis.
In response to the Staff’s comment, the Company has:
1. deleted disclosure previously appearing in Amendment No. 1 to the Registration Statement indicating that mycophenolate has been
reported to be “clinically effective in uveitis.”
2. Included additional disclosure on page 187 of Amendment No. 2 providing context to state that FDA has not approved mycophenolate
or mycophenolate sodium to treat patients with uveitis and that FDA would need to review clinical trial data in order to determine that
these drugs were safe and effective to treat uveitis.
Our Strategy, page 173
10. We note your response to prior comment 25. Please also include a discussion here and on page 175 stating that, to date, you
have not had any meetings with the FDA regarding Phase 3 trial protocols or regarding obtaining orphan drug designation, as you do on
page 62, and that although you plan to receive orphan drug designation, there is no guarantee that such designation will be granted.
In response to the Staff’s comment, the Company has added disclosure
to page 190 of Amendment No. 2 to state that to date, Vyome has not had any meetings with the FDA regarding Phase 3 trial
protocols or regarding obtaining orphan drug designation, and although Vyome plans to receive orphan drug designation, there is no guarantee
that such designation will be granted.
Vyome’s differentiated development engine, page 174
11. In your response letter, in response to prior comment 26 you state that you have revised disclosure on page 174. We do not
note any changes on page 174, as such we reissue the comment. Please revise the last paragraph on page 174 to avoid the implication
that the FDA provides general approval for use of a molecule.
In response to the Staff’s comment, the Company has revised the
disclosure on page 191 of Amendment No. 2 to avoid the implication. Further, the Company would also like to clarify
that in line with response to the prior comment 26, the disclosure in Amendment No. 1 to the Registration Statement under the referenced
sub-section had previously been revised to avoid the implication that the FDA provides general approval for the use of molecule, along
with quoting additional studies to emphasize that at the same time, the data generated from clinical studies that led to an approval of
a molecule for an indication can be leveraged to support safety for label expansions (i.e. the drugs’ use in treating additional
indications).
Vyome’s Product Portfolio, page 176
12. We note that in response to prior comment 22 you state that you plan to use approximately $2.75 million for continued research
and development towards regulatory work and pivotal trial of VT-1953. Please clarify if this plan is for one or both indications of VT-1053.
In response to the Staff’s comment, the Company has revised the
disclosure on page 193 of Amendment No. 2 to clarify that the amount of $2.75 million is only for the therapeutic indication
of treating malodor in malignant fungating wounds. Additionally, the Company has also revised similar disclosure appearing under heading
titled “Expected Use of Proceeds” under the section titled “Vyome Management’s Discussion and Analysis of Financial
Condition and Results of Operations.”
13. We note your response to prior comment 29. Please remove the MRT Platform from the pipeline table because its inclusion indicates
that the platform has undergone clinical trials and received FDA approval. We would not object to a separate table for OTC products provided
it is clear that these OTC products are out-licensed for sales in India.
In response to the Staff’s comment, the Company has removed the
MRT platform from the pipeline table on page 192 of Amendment No. 2; further, a separate table for the MRT platform has been
included with the table clarifying that the product is being commercialized in India.
Pre-Clinical Toxicity Studies, page 180
14. We note your response to prior comment 31. Please revise to discuss the significance of each Cmax, AUC, and Tmax value. Further,
define CDLQI at first use.
In response to the Staff’s comment, the Company has revised
the disclosure beginning on page 197 of Amendment No. 2 to discuss the significance of each Cmax, AUC and Tmax
value. Further, the Company has also revised the disclosure to define CDLQI at first use.
15. In response to prior comment 32 you state that Phase 1 studies are typically performed on healthy volunteers and do not need to
be performed on patients with specific diseases for which it will be studied in pivotal studies. Please revise to clarify whether the
Phase 1 open-label, safety, tolerability and pharmacokinetics study conducted on 12 patients with moderate to severe facial acne vulgaris
will serve as the Phase 1 data for your future NDA applications pertaining to the MFW indication and the Inflammatory acne indication.
In response to the Staff’s comment, the Company has revised the
disclosure on page 203 of Amendment No. 2 to clarify that the safety and pharmacokinetics data from the Phase 1 and 2 clinical
studies referenced will be included in future NDA applications to the FDA and other regulatory agencies to support the topical use of
VT-1953 to treat different inflammatory conditions, including MFW and inflammatory acne.
Commercialization, page 199
16. In response to prior comment 39 you discuss the Development and Licensing Agreement with Sun Pharma. We note that Vyome is entitled
to “additional sales linked milestone payments upon launch of the product based upon the outcome of a clinical.” Please quantify
the additional milestone payments and discuss the outcome of the clinical trial referenced.
In response to the Staff’s comment, the Company has revised the
disclosure on page 217 of Amendment No. 2 to include disclosure listing out the additional sales-linked milestone payments
under the Development and Licensing Agreement with Sun Pharma. In addition, the Company has also revised the disclosure to clarify that
the clinical trial study has not been completed yet.
4. Share Issuances, page 279
17. You disclose that the $28,562 in the table on page 281 represents the equity portion of the purchase price. Please provide
a table breaking out the components of the entire purchase price and clarify, if such is the case, that the $28,562 is presented in thousands.
In response to the Staff’s comment, the Company has added disclosure
to page 308 of Amendment No. 2
Unaudited Pro Forma Condensed Combined Financial Statements
5. Notes to Unaudited Pro Forma Condensed Combined Balance Sheet-Pro
Forma Adjustments, page 281
18. Please separately disclose the amount of each adjustment included in adjustment C on page 282.
In response to the Staff’s comment, the Company has added disclosure
to page 310 of Amendment No. 2
* * * * *
Thank you for your review of the submissions. If you should have any
questions regarding the response letter, please do not hesitate to contact the Company’s outside legal counsel, Brett Hanson
2025-01-14 - CORRESP - Vyome Holdings, Inc
CORRESP
1
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January 14, 2025
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn: Doris Stacey Gama and Joe McCann
Re: ReShape Lifesciences Inc.
Registration Statement on Form S-1
Filed December 20, 2024
File No. 333-283952
Ladies and Gentlemen:
ReShape Lifesciences Inc. (the “Company,” “ReShape,”
“we,” or “our”) is submitting this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) received by electronic mail dated January 3, 2025,
relating to the Registration Statement on Form S-1 filed December 20, 2024 by the Company (the “Registration Statement”).
Amendment No. 1 to the Registration Statement (“Amendment No. 1”) is being submitted via EDGAR concurrently
herewith responding to the Staff’s comments and including certain other revisions and updates. The numbered paragraphs below correspond
to the numbered comments in the Staff’s letter, and the Staff’s comments are presented in italics.
Page numbers in the text of the Company’s responses correspond
to page numbers in Amendment No. 1. Please note that capitalized terms used but not otherwise defined in this letter have the
meanings ascribed to such terms in Amendment No. 1.
Our responses are as follows:
Registration Statement on Form S-1
Prospectus Summary, page 3
1. We note that the first three pages of the Summary highlight the business operations that you have agreed to sell pursuant
to the terms of an Asset Purchase Agreement with Ninjour Health International Limited. We further note that the Use of Proceeds indicates
that the offering proceeds will be directed to expenses relating to this asset sale and the acquisition of the Vyome business. Please
revise the Summary to provide balance to this section. Highlight the purpose of the equity line and convertible notes arrangement while
also explaining the risk that the closing of the merger and asset sale both remain subject to shareholder approval and other contingencies.
In response to the Staff’s comment, the Company has revised the
disclosure on page 4 of Amendment No. 1.
Use of Proceeds, page 48
2. Please revise to provide the disclosure referenced in Instruction 4 to Regulation S-K, Item 504.
In response to the Staff’s comment, the Company has revised the
disclosure on page 51 of Amendment No. 1.
General
3. We note your disclosure on page 6 that on July 8, 2024 you entered into an agreement and plan of merger with Vyome Therapeutics
and that on October 1, 2024 you filed a registration statement on Form S-4 in connection with the merger. Please amend to include
Vyome Therapeutics’ financial statements as required by Regulation S-X Item 3-05.
In response to the Staff’s comment, the Company has included
Vyome Therapeutics’ financial statements in Amendment No. 1.
* * * * *
Thank you for your review of the submissions. If you should have any
questions regarding the response letter, please do not hesitate to contact the Company’s outside legal counsel, Brett Hanson of
Fox Rothschild LLP, at (612) 607-7330.
Sincerely,
/s/ Paul Hickey
Paul Hickey
cc: Brett Hanson, Fox Rothschild LLP
2025-01-03 - UPLOAD - Vyome Holdings, Inc File: 333-283952
January 3, 2025
Paul F. Hickey
Chief Executive Officer
ReShape Lifesciences Inc.
18 Technology Dr, Suite 110
Irvine, CA 92618
Re:ReShape Lifesciences Inc.
Registration Statement on Form S-1
Filed December 20, 2024
File No. 333-283952
Dear Paul F. Hickey:
We have conducted a limited review of 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-1
Prospectus Summary, page 3
1.We note that the first three pages of the Summary highlight the business operations
that you have agreed to sell pursuant to the terms of an Asset Purchase Agreement
with Ninjour Health International Limited. We further note that the Use of Proceeds
indicates that the offering proceeds will be directed to expenses relating to this asset
sale and the acquisition of the Vyome business. Please revise the Summary to provide
balance to this section. Highlight the purpose of the equity line and convertible notes
arrangement while also explaining the risk that the closing of the merger and asset
sale both remain subject to shareholder approval and other contingencies.
January 3, 2025
Page 2
Use of Proceeds, page 48
2.Please revise to provide the disclosure referenced in Instruction 4 to Regulation S-K,
Item 504.
General
3.We note your disclosure on page 6 that on July 8, 2024 you entered into an agreement
and plan of merger with Vyome Therapeutics and that on October 1, 2024 you filed a
registration statement on Form S-4 in connection with the merger. Please amend to
include Vyome Therapeutics' financial statements as required by Regulation S-X Item
3-05.
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 Doris Stacey Gama at 202-551-3188 or Joe McCann at 202-551-6262
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Brett Hanson, Esq.
2024-12-20 - UPLOAD - Vyome Holdings, Inc File: 333-282459
December 20, 2024
Paul Hickey
President and Chief Executive Officer
ReShape Lifesciences Inc.
18 Technology Dr., Suite 110
Irvine, CA 92618
Re:ReShape Lifesciences Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed December 6, 2024
File No. 333-282459
Dear Paul Hickey:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our October 31, 2024 letter.
Amendment No. 1 to Registration Statement on Form S-4
Cover Page
1.We refer to prior comment 2. With reference to the disclosure on page 14, please
revise the prospectus coverpage to highlight the equity percentage range (between
88.9% and 92.31%).
Q:What is the proposed Asset Sale?, page 1
We note your response to prior comment 16. Please revise the Q&A to explain that
ReShape expects to use substantially all of the proceeds it received from the Asset
Sale to pay transaction expenses related to the Merger and Asset Sale and ordinary
course accounts payable. Similarly, revise the disclosure on page 118 concerning
Maxim's valuation analysis to clarify why ReShape expects to only having $1.5 2.
December 20, 2024
Page 2
million in cash as opposed to $5.16 million or more at closing.
Q. What are the put-call option agreements to be entered into with certain stockholders of
Vyome and Vyome India..., page 2
3.We note your revised disclosure in response to prior comment 3. Revise the disclosure
at the bottom of page 2 to explain the "certain price" relating to the combined
company's call option. We also note that your beneficial ownership table on page 267
indicates that the two affiliated Navam entities hold approximately half of the entitled
shares (751,147). Please tell us whether any other Directors, Officers or 5% holders
beneficially own entitled shares that are subject to the put-call option agreement,
including shares underlying options.
The Merger
Background of Merger, page 105
4.We note your response to prior comment 12. Please revise the January 23 entry to
disclose the merger consideration and the plans for ReShape’s business assets.
Opinion of ReShape's Financial Advisor - Maxim Group LLC, page 115
5.We note your response to prior comment 15. We also note that your disclosure
continues to state that the Maxim opinion "was not prepared for ReShape’s
stockholders or any other person or entity, nor will it grant them any rights or
remedies." Please remove this statement or disclose the basis for Maxim's belief that
shareholders cannot rely on the opinion to support any claims against Maxim arising
under applicable state law (e.g., the inclusion of an express disclaimer in Maxim’s
engagement letter with the company). Describe any applicable state-law authority
regarding the availability of such a potential defense. In the absence of applicable
state-law authority, disclose that the availability of such a defense will be resolved by
a court of competent jurisdiction. Also disclose that resolution of the question of the
availability of such a defense will have no effect on the rights and responsibilities of
the board of directors under applicable state law. Further disclose that the availability
of such a state-law defense to Maxim would have no effect on the rights and
responsibilities of either Maxim or the board of directors under the federal securities
laws.
Certain U.S. Federal Income Tax Consequences, page 126
6.With reference to prior comment 21, we note the revised disclosure on page 126
stating that there are no U.S. federal income tax consequences of the Merger or Asset
Sale to U.S. Holders of ReShape Shares. Please revise to provide a tax opinion
regarding these tax matters and consequences to the ReShape shareholders. Refer to
Regulation S-K, Item 601(b)(8).
U.S. Federal Income Tax Consequences of the Merger to U.S. Holders of Vyome Shares,
page 128
7.With reference to Exhibit 8.1, please revise to disclose that the disclosure in the
section constitutes the opinion of Sichenzia Ross Ference Carmel LLP, or advise.
December 20, 2024
Page 3
Our Programs, page 171
8.We note your statement that the active agent in VT-1953 is approved by the US-FDA
(NDA#22-308) as an eye drop for the treatment of bacterial conjunctivitis. We note
that NDA#22-308 approved the drug Besivance for the treatment of bacterial
conjunctivitis. An FDA approval is for the drug as a whole for a specific indication
and not for a specific ingredient used in the formulation. As such, please revise the
statement that the active agent in VT-1953 is approved by the US-FDA.
9.We note your revised disclosure in response to prior comment 24. Please remove the
disclosure indicating that mycophenolate has been reported to be "clinically effective
in unveitis." To the extent that you include the quotations from the published third
party studies, please provide context by disclosing in the same paragraph, if true, that
FDA has not approved mycophenolate or mycophenolate sodium to treat patients
with uveitis and that FDA would need to review clinical trial data in order to
determine that these drugs were safe and effective to treat uveitis.
Our Strategy, page 173
10.We note your response to prior comment 25. Please also include a discussion here and
on page 175 stating that, to date, you have not had any meetings with the FDA
regarding Phase 3 trial protocols or regarding obtaining orphan drug designation, as
you do on page 62, and that although you plan to receive orphan drug designation,
there is no guarantee that such designation will be granted.
Vyome's differentiated development engine, page 174
11.In your response letter, in response to prior comment 26 you state that you have
revised disclosure on page 174. We do not note any changes on page 174, as such we
reissue the comment. Please revise the last paragraph on page 174 to avoid the
implication that the FDA provides general approval for use of a molecule.
Vyome's Product Portfolio, page 176
12.We note that in response to prior comment 22 you state that you plan to use
approximately $2.75 million for continued research and development towards
regulatory work and pivotal trial of VT-1953. Please clarify if this plan is for one or
both indications of VT-1053.
13.We note your response to prior comment 29. Please remove the MRT Platform from
the pipeline table because its inclusion indicates that the platform has undergone
clinical trials and received FDA approval. We would not object to a separate table for
OTC products provided it is clear that these OTC products are out-licensed for sales in
India.
Pre-Clinical Toxicity Studies, page 180
14.We note your response to prior comment 31. Please revise to discuss the significance
of each Cmax, AUC, and Tmax value. Further, define CDLQI at first use.
In response to prior comment 32 you state that Phase 1 studies are typically performed
on healthy volunteers and do not need to be performed on patients with specific 15.
December 20, 2024
Page 4
diseases for which it will be studied in pivotal studies. Please revise to clarify
whether the Phase 1 open-label, safety, tolerability and pharmacokinetics study
conducted on 12 patients with moderate to severe facial acne vulgaris will serve as the
Phase 1 data for your future NDA applications pertaining to the MFW indication and
the Inflammatory acne indication.
Commercialization, page 199
16.In response to prior comment 39 you discuss the Development and Licensing
Agreement with Sun Pharma. We note that Vyome is entitled to "additional sales
linked milestone payments upon launch of the product based upon the outcome of a
clinical." Please quantify the additional milestone payments and discuss the outcome
of the clinical trial referenced.
4. Share Issuances, page 279
17.You disclose that the $28,562 in the table on page 281 represents the equity portion of
the purchase price. Please provide a table breaking out the components of the entire
purchase price and clarify, if such is the case, that the $28,562 is presented in
thousands.
Unaudited Pro Forma Condensed Combined Financial Statements
5. Notes to Unaudited Pro Forma Condensed Combined Balance Sheet-Pro Forma
Adjustments, page 281
18.Please separately disclose the amount of each adjustment included in adjustment C on
page 282.
Please contact Gary Newberry at 202-551-3761 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Doris Stacey Gama at 202-551-3188 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Brett Hanson, Esq.
2024-12-05 - CORRESP - Vyome Holdings, Inc
CORRESP
1
filename1.htm
December 5, 2024
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn: Doris Stacey Gama and Joe McCann
Re: ReShape Lifesciences Inc.
Registration Statement on Form S-4
Filed October 1, 2024
File No. 333-282459
Ladies and Gentlemen:
ReShape Lifesciences Inc. (the “Company,” “ReShape,”
“we,” or “our”) is submitting this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) received by electronic mail dated October 31, 2024,
relating to the Registration Statement on Form S-4 filed October 1, 2024 by the Company (the “Registration Statement”).
Amendment No. 1 to the Registration Statement (“Amendment No. 1”) is being submitted via EDGAR concurrently
herewith responding to the Staff’s comments and including certain other revisions and updates. The numbered paragraphs below correspond
to the numbered comments in the Staff’s letter, and the Staff’s comments are presented in italics.
Page numbers in the text of the Company’s responses correspond
to page numbers in Amendment No. 1. Please note that capitalized terms used but not otherwise defined in this letter have the
meanings ascribed to such terms in Amendment No. 1.
Our responses are as follows:
Registration Statement on Form S-4
Cover Page
1. With reference to your disclosure on page 5, please revise the coverpage to highlight that the closing of the Merger
is conditioned on Nasdaq approval for the new listing application.
In response to the Staff’s comment, the Company has revised the
disclosure on the cover page of Amendment No. 1.
2. With reference to your tabular disclosure on page 13, please revise to disclose, if true, that Vyome shareholders could receive
a maximum of 92.31% of the equity in the combined company. We also note the uncertainty in terms of the timing of the Determination Date.
Please explain how you will inform shareholders of the exchange ratio once it is established. Also, please tell us how fluctuation in
the price of the ReShape Shares impacts ReShape’s actual net cash position.
In response to the Staff’s comment, the Company has revised the
disclosure on page 14 of Amendment No. 1.
Questions and Answers about the Merger…, page 1
3. Given their impact on the Exchange Ratio, please revise to include a Summary Question and Answer that explains what “put-call”
options are and the reason(s) why the Combined Company is issuing them to certain Vyome holders. Discuss the volume of shares subject
to the arrangement.
In response to the Staff’s comment, the Company has revised the
disclosure beginning on page 2 of Amendment No. 1.
Q. Are Vyome stockholders entitled to appraisal rights?, page 8
4. You state that if the merger is complete, Vyome stockholders who have not waived such rights are entitled to appraisal rights.
Please disclose here how Vyome stockholders need to vote if they wish to retain their appraisal rights. We note on page 130 you state
that Vyome stockholders electing to exercise appraisal rights must have not voted "for" or consented to the merger. Please clarify
here and on page 130 whether a vote "against" or abstaining from voting is sufficient to retain appraisal rights.
In response to the Staff’s comment, the Company has revised the
disclosure on page 10 of Amendment No. 1 to disclose that stockholders of Vyome who did not provide their written consent to
the Merger are entitled to appraisal rights.
The Combined Company Board and Management After the Merger, page 13
5. Please revise to highlight your disclosure on page 39 regarding the part-time service of certain officers and directors.
The Company has revised the disclosure on page 15 of Amendment
No. 1 regarding the part-time service of certain officers and directors and included cross-reference to the risk factors section
where such other commitments of certain officers and directors are further discussed.
Opinion of ReShape’s Financial Advisor, page 15
6. With reference to the disclosure on page 113, please revise to highlight that Maxim did not opine on the fairness of the sale
of ReShape's business assets.
In response to the Staff’s comment, the Company has revised the
disclosure on page 16 of Amendment No. 1.
ReShape directors and executive officers and Vyome directors
and executive officers have interests in the Merger…, page 26
7. With a view to disclosure here or elsewhere in the proxy-prospectus, please tell us whether officers, directors or affiliates have
interests in the ReShape Asset Sale transactions.
In response to the Staff’s comment, the Company has revised the
disclosure on page 28 of Amendment No. 1.
The Combined Company’s ability to use net operating losses…,
page 37
8. Please state the total NOL carryforward you may be eligible to receive.
In response to the Staff’s comment, the Company has revised the
disclosure on page 37 of Amendment No. 1.
We are substantially dependent on the success of VT-1953 and
VT-1908…, page 62
9. You state that you also plan to initiate IND enabling studies followed by Phase 1 and 2 trials commencing in the last quarter of
2025. Please clarify the product candidate(s) you are referencing.
In response to the Staff’s comment, the Company has revised the
disclosure on page 62 of Amendment No. 1 to clarify that Vyome intends to initiate enabling studies for VT-1908.
The Merger
Background of the Merger, page 104
10. You state that on September 20, 2023 ReShape entered into a buy-side M&A advisory agreement with Maxim. Please discuss
the company's reasons for entering into such agreement.
In response to the Staff’s comment, the Company has revised the
disclosure on page 105 of Amendment No. 1.
11. We note the disclosure indicating that ReShape entered into a mutual confidentiality agreement with Vyome on December 20.
Revise to explain when and how the parties first met. Identify the individuals involved in those discussions.
In response to the Staff’s comment, the Company has revised the
disclosure on page 105 of Amendment No. 1.
12. Please revise to present the material terms of the January 23 submission. Discuss the merger consideration and the plans for
ReShape’s business assets.
In response to the Staff’s comment, the Company has revised the
disclosure on page 105 of Amendment No. 1.
13. You state that in early March you began discussions with potential investors regarding concurrent financing. Please revise
to discuss the amount of financing that the parties sought to raise in the financing and how they determined that amount.
In response to the Staff’s comment, the Company has revised the
disclosure on page 107 of Amendment No. 1 to discuss the amount of financing that the parties sought to raise in the Concurrent
Financing and the considerations taken into account in arriving at such amount.
14. You
state that on March 24, 2024 ReShape submitted an initial draft of the Asset Purchase
Agreement to Biorad. Please briefly discuss the material terms of the agreement.
In response to the Staff’s comment, the Company has revised the
disclosure on page 107 of Amendment No. 1.
Opinion of ReShape’s Financial Advisor - Maxim Group LLC,
page 112
15. You state that the Maxim Opinion was directed to and for the information of the ReShape Board only and was not prepared for ReShape's
stockholders or any other person or entity, nor will it grant them any rights or remedies. Investors are entitled to rely on the opinion
presented to them in this proxy/prospectus. Please revise this disclosure and the fairness opinion accordingly.
In response to the Staff’s comment, the Company has revised the
disclosure on page 115 of Amendment No. 1.
ReShape Valuation Analysis, page 117
16. We note your disclosure on pages 2 and 108 that the Merger Agreement Proposal and the Asset Sale Proposal are conditioned
upon one another and that the Asset Sale proceeds will be factored into the Exchange Ratio. Accordingly, please explain why Maxim’s
valuation analysis reflects ReShape only having $1.5 million in cash as opposed to $5.16 million or more at closing.
ReShape expects to use substantially all of the cash purchase price
from the Asset Sale to pay transaction expenses related to the Merger and Asset Sale and ordinary course accounts payable simultaneously
with the closing of the Merger.
Certain Vyome Management Prospective Financial Information, page 119
17. Please revise to disclose all material assumptions and contingencies relating to Vyome's projections. Discuss material uncertainties,
as applicable. Identify material product revenue streams driving the projections for all years presented. For example, it should be clear,
if true, that certain product candidate or candidates would need to be commercialized in 2027 to generate the $58.7 million in forecasted
revenue.
In response to the Staff’s comment, the Company has revised the
disclosure beginning on page 121 of Amendment No. 1.
18. Please revise to disclose whether and if so how the ReShape Board assessed the achievability of the Vyome Forecasts. In this regard,
it should be clear whether the ReShape Board determined the forecasts to be reasonable and/or reliable for purposes of use in Maxim’s
valuation models. Here we note the disclosure on page 237 indicating that Vyome does not expect to generate revenue from sales of
any biotechnology product candidates for a number of years, if ever.
In response to the Staff’s comment, the Company has revised the
disclosure on page 120 of Amendment No. 1.
Miscellaneous, page 119
19. Please revise to disclose the fee payable to Maxim and any conditions to payment. Also, we note that you entered into a buy-side
M&A advisory agreement. Please tell us whether you entered into a sell-side M&A advisory agreement or similar arrangement with
respect to the sale of substantially all of your non-cash assets.
Maxim has only one agreement with the Company as referenced in Amendment
No. 1 by the following sentence on page 120: ‘Maxim has also acted as an exclusive financial advisor to ReShape pursuant
to an agreement dated September 20, 2023, as amended on June 19, 2024, and upon the consummation of the Merger will be paid
a fixed cash fee.’ This is the only agreement in place between the Company and Maxim and the fixed payment includes the fee associated
with the sale of substantially all of the Company’s non-cash assets. Further, the fixed fee is contingent upon closing of the Merger.
Concurrent Financing, page 122
20. Please revise to disclose the method or methods the parties will use to value the combined company.
In response to the Staff’s comment, the Company has revised the
disclosure on page 124 of Amendment No. 1 to clarify the method that the parties will use to value the Combined Company in line
with the Merger Agreement.
Certain U.S. Federal Income Tax Consequences, page 124
21. Please revise to disclose the material tax consequences to the ReShape holders of the Merger and Asset Sale transaction(s). Also,
revise the Summary section to describe these consequences.
In response to the Staff’s comment, the Company has revised the
disclosure on pages 126 and 128 of Amendment No. 1.
Description of Vyome’s Business, page 168
22. Please revise to discuss Vyome's operating plan, including its plans for allocating the proceeds from the Merger, Asset Sale and
Concurrent Financing. With reference to the pipeline table on page 173, revise to discuss how Vyome plans to allocate the proceeds
across the four identified programs and which phase or phases of development are planned for that funding.
In response to the Staff’s comment, the Company has added the
disclosure beginning on page 176 of Amendment No. 1.
Our Programs, page 169
23. We note that you make several assertions regarding the safety and/or efficacy of the product candidates VT-1908 and VT-1953. Please
revise your disclosure to eliminate suggestions of safety and efficacy as those determinations are solely within the authority of the
FDA or comparable foreign regulators. Please present clinical trial end points and objective trial data without concluding efficacy. You
may state that your product is well tolerated, if true. For instance, and without limitation, we note the following statements:
· "VT-1908 exhibited efficacy..." (pg. 169)
· "...the active agent in VT-1953 is more effective..." (pg. 176)
· "...was more effective in reducing inflammation..." (pg. 176)
· "The safety of VT-1953 2% gel has been established..." (pg. 179)
· "Figure 7... demonstrating the safety..." (pg. 179)
· "...as we set the benchmark for clinical efficacy..." (pg. 182)
· "Figure 11. VT-1908 eye drop is effective..." (pg. 183)
· "Figure 16... with excellent safety..." (pg. 186)
· "VT-1953 demonstrated excellent efficacy..." (pg. 187)
In response to the Staff’s comment, Vyome has removed any assertions
regarding the safety and/or efficacy of the product. Vyome has replaced them with objective trial data points. Any reference to efficacy
or tolerability is now a direct reproduction of the conclusions/recommendations made by the clinical investigators in their clinical reports.
24. Please tell us your basis for asserting that "off-label" oral use of this active agent is clinically effective in uveitis.
In this regard, we note that efficacy determinations are solely within the authority of FDA and similar foreign regulators.
Vyome has revised the disclosure on page 190 to highlight that
the off-label use of the active agent in VT-1908 (mycophenolate) has been reported to be clinically effective in uveitis.
Once a drug is approved by the FDA, any clinician can use it ‘off-label’.
In this case, the active agent (mycophenolate) in VT-1908 is already approved by the FDA as an immunosuppressant for preventing transplant
rejection. There are multiple published reports of the use of oral mycophenolate in uveitis, which have now been referenced in the revised
disclosure. Please also note that Vyome has just reproduced independent published clinical findings and not made any independent assertions
on efficacy in the updated disclosures.
Our Strategy, page 170
25. We note your disclosure on page 62 indicating that you have not yet had meetings with FDA regarding the Phase 3 trial protocols
or for obtaining orphan drug designation for VT-1953. Accordingly, please tell us whether you have a basis to disclose that your clinical
trial will be pivotal, short and/or conducted with small patient populations. Provide context to any disclosures that speculate as to
the size or duration of any trial where the trial protocols have not been determined.
Malignant fungating wound is a rare indication in oncology. Most cancers
are considered as orphan conditions, and MFW occurs in 5-10% of such patients, which makes it extremely rare. Mathematically, based on
the incidence rate, it meets the less than 200,000 patients being affected criteria for being classified as an orphan condition.
Vyome has revised the disclosure beginning on page 173 to add
studies reported in journals and publications which state that typical pivotal oncology trials, especially for rare and unmet indications,
require small patient sample sizes.
MFW is a rare medical condition for which there are no approved treatments.
Hence, based on extensive prior examples, and based on the emerging Phase 2 data from the investigator-initiated trial testing VT-1953
in MFW, Vyome believes that there is a strong basis to expect a similar regulatory treatment. Note that unlike other clinical trials,
where a patients needs to be treated for many months, in this case, the patient is treated for 15 days. This shortens the duration of
the trial, which together with reduced pa
2024-11-01 - UPLOAD - Vyome Holdings, Inc File: 333-282459
October 31, 2024
Paul Hickey
President and Chief Executive Officer
ReShape Lifesciences Inc.
18 Technology Dr., Suite 110
Irvine, CA 92618
Re:ReShape Lifesciences Inc.
Registration Statement on Form S-4
Filed October 1, 2024
File No. 333-282459
Dear Paul Hickey:
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.With reference to your disclosure on page 5, please revise the coverpage to highlight
that the closing of the Merger is conditioned on Nasdaq approval for the new listing
application.
2.With reference to your tabular disclosure on page 13, please revise to disclose, if true,
that Vyome shareholders could receive a maximum of 92.31% of the equity in the
combined company. We also note the uncertainty in terms of the timing of the
Determination Date. Please explain how you will inform shareholders of the exchange
ratio once it is established. Also, please tell us how fluctuation in the price of
the ReShape Shares impacts ReShape’s actual net cash position.
October 31, 2024
Page 2
Questions and Answers about the Merger..., page 1
3.Given their impact on the Exchange Ratio, please revise to include a Summary
Question and Answer that explains what “put-call” options are and the reason(s) why
the Combined Company is issuing them to certain Vyome holders. Discuss the
volume of shares subject to the arrangement.
Q: Are Vyome stockholders entitled to appraisal rights?, page 8
4.You state that if the merger is complete, Vyome stockholders who have not waived
such rights are entitled to appraisal rights. Please disclose here how Vyome
stockholders need to vote if they wish to retain their appraisal rights. We note on page
130 you state that Vyome stockholders electing to exercise appraisal rights must have
not voted "for" or consented to the merger. Please clarify here and on page 130
whether a vote "against" or abstaining from voting is sufficient to retain appraisal
rights.
The Combined Company Board and Management After the Merger, page 13
5.Please revise to highlight your disclosure on page 39 regarding the part-time service
of certain officers and directors.
Opinion of ReShape's Financial Advisor, page 15
6.With reference to the disclosure on page 113, please revise to highlight that Maxim
did not opine on the fairness of the sale of ReShape's business assets.
ReShape directors and executive officers and Vyome directors and executive officers have
interests in the Merger..., page 26
7.With a view to disclosure here or elsewhere in the proxy-prospectus, please tell us
whether officers, directors or affiliates have interests in the ReShape Asset Sale
transactions.
The Combined Company's ability to use net operating losses..., page 37
8.Please state the total NOL carryforward you may be eligible to receive.
We are substantially dependent on the success of VT-1953 and VT-1908..., page 62
9.You state that you also plan to initiate IND enabling studies followed by Phase 1 and
2 trials commencing in the last quarter of 2025. Please clarify the product candidate(s)
you are referencing.
The Merger
Background of the Merger, page 104
10.You state that on September 20, 2023 ReShape entered into a buy-side M&A advisory
agreement with Maxim. Please discuss the company's reasons for entering into such
agreement.
11.We note the disclosure indicating that ReShape entered into a mutual confidentiality
agreement with Vyome on December 20. Revise to explain when and how the parties
first met. Identify the individuals involved in those discussions.
October 31, 2024
Page 3
12.Please revise to present the material terms of the January 23 submission. Discuss the
merger consideration and the plans for ReShape's business assets.
13.You state that in early March you began discussions with potential investors regarding
concurrent financing. Please revise to discuss the amount of financing that the parties
sought to raise in the financing and how they determined that amount.
14.You state that on March 24, 2024 ReShape submitted an initial draft of the Asset
Purchase Agreement to Biorad. Please briefly discuss the material terms of the
agreement.
Opinion of ReShape's Financial Advisor - Maxim Group LLC, page 112
15.You state that the Maxim Opinion was directed to and for the information of the
ReShape Board only and was not prepared for ReShape's stockholders or any other
person or entity, nor will it grant them any rights or remedies. Investors are entitled to
rely on the opinion presented to them in this proxy/prospectus. Please revise this
disclosure and the fairness opinion accordingly.
Reshape Valuation Analysis, page 117
16.We note your disclosure on pages 2 and 108 that the Merger Agreement Proposal and
the Asset Sale Proposal are conditioned upon one another and that the Asset Sale
proceeds will be factored into the Exchange Ratio. Accordingly, please explain why
Maxim’s valuation analysis reflects ReShape only having $1.5 million in cash as
opposed to $5.16 million or more at closing.
Certain Vyome Management Prospective Financial Information, page 119
17.Please revise to disclose all material assumptions and contingencies relating to
Vyome's projections. Discuss material uncertainties, as applicable. Identify material
product revenue streams driving the projections for all years presented. For example,
it should be clear, if true, that certain product candidate or candidates would need to
be commercialized in 2027 to generate the $58.7 million in forecasted revenue.
18.Please revise to disclose whether and if so how the ReShape Board assessed the
achievability of the Vyome Forecasts. In this regard, it should be clear whether the
ReShape Board determined the forecasts to be reasonable and/or reliable for purposes
of use in Maxim’s valuation models. Here we note the disclosure on page 237
indicating that Vyome does not expect to generate revenue from sales of any
biotechnology product candidates for a number of years, if ever.
Miscellaneous, page 119
19.Please revise to disclose the fee payable to Maxim and any conditions to payment.
Also, we note that you entered into a buy-side M&A advisory agreement. Please tell
us whether you entered into a sell-side M&A advisory agreement or similar
arrangement with respect to the sale of substantially all of your non-cash assets.
Concurrent Financing, page 122
20.Please revise to disclose the method or methods the parties will use to value the
combined company.
October 31, 2024
Page 4
Certain U.S. Federal Income Tax Consequences, page 124
21.Please revise to disclose the material tax consequences to the ReShape holders of the
Merger and Asset Sale transaction(s). Also, revise the Summary section to describe
these consequences.
Description of Vyome's Business, page 168
22.Please revise to discuss Vyome's operating plan, including its plans for allocating the
proceeds from the Merger, Asset Sale and Concurrent Financing. With reference to
the pipeline table on page 173, revise to discuss how Vyome plans to allocate the
proceeds across the four identified programs and which phase or phases of
development are planned for that funding.
Our Programs, page 169
23.We note that you make several assertions regarding the safety and/or efficacy of the
product candidates VT-1908 and VT-1953. Please revise your disclosure to eliminate
suggestions of safety and efficacy as those determinations are solely within the
authority of the FDA or comparable foreign regulators. Please present clinical trial
end points and objective trial data without concluding efficacy. You may state that
your product is well tolerated, if true. For instance, and without limitation, we note the
following statements:
•"VT-1908 exhibited efficacy..." (pg. 169)
•"...the active agent in VT-1953 is more effective..." (pg. 176)
•"...was more effective in reducing inflammation..." (pg. 176)
•"The safety of VT-1953 2% gel has been established..." (pg. 179)
•"Figure 7... demonstrating the safety..." (pg. 179)
•"...as we set the benchmark for clinical efficacy..." (pg. 182)
•"Figure 11. VT-1908 eye drop is effective..." (pg. 183)
•"Figure 16... with excellent safety..." (pg. 186)
•"VT-1953 demonstrated excellent efficacy..." (pg. 187)
24.Please tell us your basis for asserting that "off-label" oral use of this active agent is
clinically effective in uveitis. In this regard, we note that efficacy determinations are
solely within the authority of FDA and similar foreign regulators.
Our Strategy, page 170
25.We note your disclosure on page 62 indicating that you have not yet had meetings
with FDA regarding the Phase 3 trial protocols or for obtaining orphan drug
designation for VT-1953. Accordingly, please tell us whether you have a basis
to disclose that your clinical trial will be pivotal, short and/or conducted with small
patient populations. Provide context to any disclosures that speculate as to the size or
duration of any trial where the trial protocols have not been determined.
October 31, 2024
Page 5
Vyome's differentiated development engine, page 171
26.We note that FDA approves drugs to treat specific indications. Accordingly, please
revise the penultimate paragraph on page 172 to avoid the implication that FDA
provides general approval for use of a molecule.
27.You state that in parallel to focusing on rare immune-inflammatory diseases as your
initial indication for drug development you are also mapping non-orphan indications
that mechanically overlap with the orphan indications. Please clarify, if true, that
clinical trials for non-orphan indications typically take a longer time to complete.
Vyome's Product Portfolio, page 173
28.We note your pipeline table includes an unidentified "Discovery" program to treat an
undisclosed indication or indications. Given the stage of development and the lack of
information about the drug candidate, please revise to remove this program from the
pipeline table.
29.We note that your pipeline table includes a row for MRT Platform similar to your
current programs under development. Please tell us your basis for including the MRT
Platform in this table. In this regard, please tell us and, if applicable, clarify whether
the MRT Platform was used to develop a new drug product that followed
the IND/NDA pathway or a similar pathway in India.
Our solution for treating symptoms of MFW, page 175
30.You state here that VT-1953 is being developed as a "first in class" topical gel; on
page 169 that VT-1953 will be the first approved treatment; and on page 185 that VB-
1953 is a best in class product for the treatment of inflammatory acne. Please remove
references throughout your prospectus to potential "first in class" and "best in class"
when describing your product candidate as these descriptions imply an expectation of
regulatory approval and are inappropriate given their development status and
uncertainty with respect to securing marketing approval.
Pre-Clinical Studies, page 177
31.We note you present Cmax, AUC, and Tmax values. At first use, please define the
terms and the significance of each results shown.
32.You state that Vyome conducted a Phase 1 open-label, safety, tolerability and
pharmacokinetic study of VT-1953 in patients with moderate to severe facial acne.
Please clarify if any Phase 1 studies were conducted for the treatment of MFW.
You state that a Phase 2 proof of concept study was conducted. Please expand your
description of the trial to provide specific details, parameters, and results of the trial,
including:
•dates of the trial and location;
•identity of trial sponsor(s);
•trial design;
•patient information (e.g., number of patients enrolled and treated and the criteria
for participation in the study);33.
October 31, 2024
Page 6
•duration of treatment and dosage information;
•primary and secondary endpoints; and
•discussion of results, including adverse events and serious adverse events, if any.
34.You state that based on your observations you aim to initiate a pivotal study to test the
efficacy of VT-1953 in malodorous MFW in early 2025. We note you reference a
Phase 1 and Phase 2 study on page 179, but it is currently unclear whether such
studies refer to product candidate VT-1953 for the indication of malodorous MFW.
To the extent such studies do not relate to VT-1953 for the malodorous MFW
indication, please explain why you believe you are in a position to initiate pivotal
studies in early 2025.
Investigator-initiated study of VT-1953 in MFW, page 180
35.You state that an open-label investigator-initiated proof of concept study was
conducted to evaluate the safety and efficacy of VT-1953. You also discuss an
investigator-initiated, open label, single-arm clinical study in patients in India with
moderate to severe vulgaris. We note your disclosure on page 68 stating that you do
not control these trials and that you hope to obtain a license to access the use and
reference of such data. Accordingly, please revise the Business section to explain that
you did not conduct this study and that it was conducted by a third-party. To the
extent that you currently do not have the right to reference such data, please revise to
explain whether and if so how this impacts your ability to conduct Phase
3/pivotal trials.
Other pipeline opportunities, page 184
36.You state that a Phase 1 open-label study was conducted in the US. Please expand
your description of the trial to provide specific details, parameters, and results of the
trial, including the dates of the trial, identity of trial sponsor(s), primary and secondary
endpoints; and discussion of results, including adverse events and serious adverse
events, if any.
37.You state two Phase 2 studies were conducted, one in the Dominican Republic and
another in the US. Please include the date of the trials, identity of the sponsor(s),
and discussion of results, including adverse events and serious adverse events, if any.
Patent Portfolio, page 188
38.We note your table listing all patents as of the date of this prospectus. Please revise to
include the type of patent protection ( e.g., composition of matter, use, or process), the
date of expiration, and whether the patents have been granted or whether patent
applications are pending.
Commercialization, page 190
You state that you have commercialized three products based on MRT Technology in
India in partnership with Sun Pharma. Please disclose the material terms of your
partnership arrangements, including a description of each party's rights and
obligations, a quantification of any payment obligations, including any royalty fees or 39.
October 31, 2024
Page 7
milestone payments, and a summary of the material terms and termination provisions.
Please also file the agreement or agreements as exhibits in accordance with Item
601(b)(10) of Regulation S-K or, alternatively, explain why you are not required to do
so.
Employment Agreements, page 212
40.We note that Vyome has employment agreements with Venkat Nelabhotla and
Robert Dickey who will be the combined company's Chief Executive Officer and
Chief Financial Officer, respectively. Please include a description of any severance
provisions or explain that there are none.
Results of Operations, page 232
41.You state that the Company derives revenue from the sale of products, including
royalties related to sales of such products from one costumer, Sun Pharma. Please
include an appropriate risk factor highlighting the risks associated with deriving all
your revenue from one customer.
Comparison of Stockholde
2023-09-28 - CORRESP - Vyome Holdings, Inc
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September 28, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, NE
Washington, DC 20549
Attn: Margaret Schwartz
Re:
ReShape Lifesciences Inc.
Registration Statement on Form S-1
Filed August 25, 2023
File No. 333-274227
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended,
ReShape Lifesciences Inc. (the “Registrant”) hereby respectfully requests that the effective date of the above-referenced
registration statement, as amended, be accelerated so that it will be declared effective at 5:30 p.m., Eastern Time, on September 28,
2023, or as soon thereafter as is practicable, or at such later time as the Registrant or its counsel may orally request via telephone
call to the staff of the Commission. The Registrant hereby authorizes Fox Rothschild LLP, counsel to the Registrant, to orally modify
or withdraw this request for acceleration.
The Registrant requests that it be notified of such effectiveness
by a telephone call to Brett Hanson of Fox Rothschild LLP at (612) 607-7330.
Thank you for your assistance in this matter. Should you have any
questions, please call Mr. Hanson.
Very truly yours,
/s/ Paul F. Hickey
Paul F. Hickey
President and Chief Executive Officer
2023-08-30 - UPLOAD - Vyome Holdings, Inc
United States securities and exchange commission logo
August 30, 2023
Paul F. Hickey
President and Chief Executive Officer
ReShape Lifesciences Inc.
18 Technology Dr, Suite 110
Irvine, California 92618
Re:ReShape Lifesciences Inc.
Registration Statement on Form S-1
Filed August 25, 2023
File No. 333-274227
Dear Paul F. Hickey:
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 Margaret Schwartz at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Brett Hanson, Esq.
2023-02-03 - CORRESP - Vyome Holdings, Inc
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February 3, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, NE
Washington, DC 20549
Attn: Abby Adams
Re: ReShape Lifesciences Inc.
Registration Statement on Form S-1
Filed January 12, 2023
File No. 333-269207
Ladies and Gentlemen:
As the underwriter of the
proposed offering of ReShape Lifesciences Inc. (the “Company”), we hereby join
the Company’s request for acceleration of the above-referenced Registration Statement, requesting effectiveness for 5:00 p.m., Eastern
Time, on Friday, February 3, 2023, or as soon thereafter as is practicable.
Pursuant to Rule 460 of the
General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, we, acting
on behalf of the several underwriters, wish to advise you that, through February 3, 2023, we distributed to each underwriter or dealer,
who is reasonably anticipated to be invited to participate in the distribution of the security, as many copies, as well as “E-red”
copies of the Preliminary Prospectus dated February 3, 2023 as appears to be reasonable to secure adequate distribution of the preliminary
prospectus.
The undersigned advise that
they have complied and will continue to comply with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Maxim Group LLC
By:
/s/ Clifford A. Teller
Name: Clifford A. Teller
Title: Co-President
2023-02-03 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm February 3, 2023 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, NE Washington, DC 20549 Attn: Abby Adams Re: ReShape Lifesciences Inc. Registration Statement on Form S-1 Filed January 12, 2023 File No. 333-269207 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, ReShape Lifesciences Inc. (the “Registrant”) hereby respectfully requests that the effective date of the above-referenced registration statement, as amended, be accelerated so that it will be declared effective at 5:00 p.m., Eastern Time, on February 3, 2023, or as soon thereafter as is practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Fox Rothschild LLP, counsel to the Registrant, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Brett Hanson of Fox Rothschild LLP at (612) 607-7330. Thank you for your assistance in this matter. Should you have any questions, please call Mr. Hanson. Very truly yours, /s/ Paul F. Hickey Paul F. Hickey President and Chief Executive Officer
2023-02-01 - CORRESP - Vyome Holdings, Inc
CORRESP
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February 1, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, NE
Washington, DC 20549
Attn: Abby Adams
Re: ReShape
Lifesciences Inc.
Registration Statement on Form S-1
Filed January 12, 2023
File No. 333-269207
Ladies and Gentlemen:
As the underwriter of the
proposed offering of ReShape Lifesciences Inc. (the “Company”), we hereby join
the Company’s request for acceleration of the above-referenced Registration Statement, requesting effectiveness for 5:00 p.m., Eastern
Time, on Thursday, February 2, 2023, or as soon thereafter as is practicable.
Pursuant to Rule 460 of the
General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, we, acting
on behalf of the several underwriters, wish to advise you that, through February 1, 2023, we distributed to each underwriter or dealer,
who is reasonably anticipated to be invited to participate in the distribution of the security, as many copies, as well as “E-red”
copies of the Preliminary Prospectus dated January 26, 2023 as appears to be reasonable to secure adequate distribution of the preliminary
prospectus.
The undersigned advise that
they have complied and will continue to comply with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Maxim Group LLC
By:
/s/ Clifford A. Teller
Name: Clifford A. Teller
Title: Co-President
2023-02-01 - CORRESP - Vyome Holdings, Inc
CORRESP
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February 1, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, NE
Washington, DC 20549
Attn: Abby Adams
Re: ReShape Lifesciences Inc.
Registration Statement
on Form S-1
Filed January 12, 2023
File No. 333-269207
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended, ReShape
Lifesciences Inc. (the “Registrant”) hereby respectfully requests that the effective date of the above-referenced registration
statement, as amended, be accelerated so that it will be declared effective at 5:00 p.m., Eastern Time, on February 2, 2023, or as soon
thereafter as is practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff
of the Commission. The Registrant hereby authorizes Fox Rothschild LLP, counsel to the Registrant, to orally modify or withdraw this request
for acceleration.
The Registrant requests that it be notified of such effectiveness by
a telephone call to Brett Hanson of Fox Rothschild LLP at (612) 607-7330.
Thank you for your assistance in this matter. Should you have any questions,
please call Mr. Hanson.
Very truly yours,
/s/ Paul F. Hickey
Paul F. Hickey
President and Chief Executive Officer
2023-01-20 - UPLOAD - Vyome Holdings, Inc
United States securities and exchange commission logo
January 20, 2023
Paul F. Hickey
President and Chief Executive Officer
ReShape Lifesciences Inc.
1001 Calle Amanecer
San Clemente, California 92673
Re:ReShape Lifesciences Inc.
Registration Statement on Form S-1
Filed January 12, 2023
File No. 333-269207
Dear Paul F. Hickey:
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 Abby Adams at (202) 551-6902 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Brett R. Hanson, Esq.
2021-09-15 - CORRESP - Vyome Holdings, Inc
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September 15, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Attn: Dillon Hagius
Re: ReShape Lifesciences Inc.
Registration Statement
on Form S-3
Filed September 3, 2021
File No. 333-259301
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended, ReShape
Lifesciences Inc. (the “Registrant”) hereby respectfully requests that the effective date of the above-referenced registration
statement be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time, on September 17, 2021, or as soon thereafter
as is practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff of the Commission.
The Registrant hereby authorizes Fox Rothschild LLP, counsel to the Registrant, to orally modify or withdraw this request for acceleration.
The Registrant requests that it be notified of such effectiveness by
a telephone call to Brett Hanson of Fox Rothschild LLP at (612) 607-7330.
Thank you for your assistance in this matter. Should you have any questions,
please call Mr. Hanson.
Very truly yours,
/s/ Barton P. Bandy
Barton P. Bandy
Chief Executive Officer
2021-09-10 - UPLOAD - Vyome Holdings, Inc
United States securities and exchange commission logo
September 10, 2021
Barton Bandy
President and Chief Executive Officer
ReShape Lifesciences Inc.
1001 Calle Amanecer
San Clemente, California 92673
Re:ReShape Lifesciences Inc.
Registration Statement on Form S-3
Filed September 3, 2021
File No. 333-259301
Dear Mr. Bandy:
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 Dillon Hagius at 202-551-7967 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brett R. Hanson
2021-04-09 - CORRESP - Vyome Holdings, Inc
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OBALON THERAPEUTICS, INC.
5421 Avenida Encinas, Suite F
Carlsbad, CA 94111
April 9, 2021
VIA EDGAR
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jan Park
Re: Obalon Therapeutics, Inc.
Registration Statement on Form S-4
(File No. 333-254841)
Ladies and Gentlemen:
Pursuant to Rule 461
promulgated under the Securities Act of 1933, as amended, we hereby respectfully request acceleration of the effective date of the Registration
Statement on Form S-4 (File No. 333-254841) (as amended, the “Registration Statement”) of Obalon Therapeutics, Inc.
(the “Company”), so that such Registration Statement will be declared effective as of 4:00 p.m. on April 13,
2021, or as soon thereafter as practicable.
Once the Registration Statement has been declared
effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Daniel Rees at (714) 755-2244.
In connection with this request for acceleration of the effective date
of the Registration Statement, the Company acknowledges the following:
· 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.
Thank you for your assistance with this matter.
If you have any questions regarding the foregoing, please do not hesitate to contact Daniel Rees of Latham & Watkins LLP at (714)
755-2244.
Very truly yours,
OBALON THERAPEUTICS, INC.
By:
/s/ Andrew
Rasdal
Name: Andrew Rasdal
Title: President and Chief Executive Officer
cc: Daniel Rees,
Latham & Watkins LLP
2020-02-27 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm Document Obalon Therapeutics, Inc. 5421 Avenida Encinas, Suite F Carlsbad, CA 92008 February 27, 2020 Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attention: Paul Fischer Re: Obalon Therapeutics, Inc. Registration Statement on Form S-1 File No. 333-236327 Dear Mr. Fischer: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned, Obalon Therapeutics, Inc., a Delaware corporation (the “Registrant”), hereby requests acceleration of the effective date of the Registration Statement referred to above so that it may become effective at 4:30 p.m. Eastern Standard Time on February 28, 2020, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling B. Shayne Kennedy at (714) 755-8181. Thank you for your assistance in this matter. [Signature Page Follows] Very truly yours, OBALON THERAPEUTICS, INC., a Delaware corporation By: /s/ William Plovanic Name: William Plovanic Title: President and Chief Executive Officer cc: B. Shayne Kennedy, Latham & Watkins LLP
2020-02-14 - UPLOAD - Vyome Holdings, Inc
February 14, 2020
William Plovanic
Chief Financial Officer
Obalon Therapeutics, Inc.
5421 Avenida Encinas, Suite F
Carlsbad, CA 92008
Re:Obalon Therapeutics, Inc.
Registration Statement on Form S-1
Filed February 7, 2020
File No. 333-236327
Dear Mr. Plovanic:
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 Paul Fischer at 202-551-3415 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Shayne Kennedy, Esq.
2019-08-01 - UPLOAD - Vyome Holdings, Inc
July 31, 2019
William Plovanic
President and Chief Financial Officer
Obalon Therapeutics, Inc.
5421 Avenida Encinas, Suite F
Carlsbad, California 92008
Re:Obalon Therapeutics, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed July 30, 2019
File No. 333-232276
Dear Mr. Plovanic:
We have limited our review of your registration statement to those issues we have
addressed in our 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.
Amendment No. 2 to Registration Statement on Form S-1
Exhibits
1.We note your forum selection provision in the warrant. Please clearly and prominently
describe the provision in your prospectus and clearly describe the risks or other impacts
on investors. Also, disclose whether the provision applies to actions arising under the
Securities Act or Exchange Act. If the provision does not apply to actions arising under
the Securities Act or the Exchange Act, please ensure that the exclusive forum provision
in the governing documents states this clearly, or tell us how you will inform investors in
future filings that the provision does not apply to any actions arising under the Securities
Act or the Exchange Act.
2.We note the provisions in exhibit 1.1 regarding the waiver on behalf of stockholders of the
right to trial by jury. Please disclose whether the provisions would apply to claims under
FirstName LastNameWilliam Plovanic
Comapany NameObalon Therapeutics, Inc.
July 31, 2019 Page 2
FirstName LastName
William Plovanic
Obalon Therapeutics, Inc.
July 31, 2019
Page 2
the federal securities laws. If so, please include a separately captioned risk factor
addressing the impact of the provisions on investors and any uncertainty regarding
enforceability. If the provisions do not apply to actions arising under the federal securities
laws, please ensure that the provisions in the governing documents state this clearly.
Please contact Thomas Jones at 202-551-3602 or Russell Mancuso, Branch Chief, at 202-
551-3617 with any questions.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: B. Shayne Kennedy
2019-08-01 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm Document VIA EDGAR Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Thomas Jones, Russell Mancuso Re: Obalon Therapeutics, Inc. Amendment No. 3 to Registration Statement on Form S-1 File No. 333-232276 Ladies and Gentlemen: On behalf of our client, Obalon Therapeutics, Inc., a Delaware corporation (the “Company”), and pursuant to the applicable provisions of the Securities Act of 1933, as amended (the “Securities Act”), and the rules promulgated thereunder, we are hereby filing Amendment No. 3 to the Registration Statement on Form S-1 (“Amendment No. 3”). The Company originally filed its Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (the “Commission”) on June 21, 2019 (the “Original Registration Statement”) and subsequently amended the Registration Statement on July 26, 2019 (“Amendment No. 1”) and July 30, 2019 (“Amendment No. 2,” and the Original Registration as amended by Amendment No.1, Amendment No. 2 and Amendment No.3, the “Registration Statement”). Amendment No. 3 has been revised to reflect the Company’s responses to the comment letter to Amendment No. 2 received July 31, 2019 from the staff of the Commission (the “Staff”). August 1, 2019 Page 2 The numbered paragraphs in italics below set forth the Staff’s comments and are followed by the Company’s response. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in the Registration Statement. Amendment No. 2 to Registration Statement on Form S-1 Exhibits 1. We note your forum selection provision in the warrant. Please clearly and prominently describe the provision in your prospectus and clearly describe the risks or other impacts on investors. Also, disclose whether the provision applies to actions arising under the Securities Act or Exchange Act. If the provision does not apply to actions arising under the Securities Act or the Exchange Act, please ensure that the exclusive forum provision in the governing documents states this clearly, or tell us how you will inform investors in future filings that the provision does not apply to any actions arising under the Securities Act or the Exchange Act. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 74 and 124 of Amendment No. 3. Additionally, the Company has filed a new Form of Warrant, attached as Exhibit 4.6, to Amendment No. 3 in which the forum selection provision has been revised to indicate that it does not apply to actions arising under the Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”). 2. We note the provisions in exhibit 1.1 regarding the waiver on behalf of stockholders of the right to trial by jury. Please disclose whether the provisions would apply to claims under the federal securities laws. If so, please include a separately captioned risk factor addressing the impact of the provisions on investors and any uncertainty regarding enforceability. If the provisions do not apply to actions arising under the federal securities laws, please ensure that the provisions in the governing documents state this clearly. Response: In response to the Staff’s comment, the Company has filed a new form of Underwriting Agreement, attached as Exhibit 1.1 to Amendment No. 3, in which Section 13 of the Underwriting Agreement has been revised to indicate that it does not apply to actions arising under the Securities Act or the Exchange Act. August 1, 2019 Page 3 We look forward to resolving any outstanding issues with respect to the Registration Statement as quickly as possible. Please do not hesitate to contact me at (714) 755-8181 with any questions or further comments you may have regarding the Registration Statement or if you wish to discuss the above or enclosed. Sincerely, /s/ B. Shayne Kennedy B. Shayne Kennedy of LATHAM & WATKINS LLP Enclosures cc: (via e-mail) William Plovanic, President and Chief Financial Officer, Obalon Therapeutics, Inc. Drew Capurro, Latham & Watkins LLP Merrill M. Kraines, Pepper Hamilton LLP Thomas E. Mitchell, Pepper Hamilton LLP
2019-07-30 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm Document A.G.P./Alliance Global Partners 590 Madison Avenue, 36th Floor New York, New York 10022 July 30, 2019 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attn: Thomas Jones, Russell Mancuso Re: Obalon Therapeutics, Inc. (the “Company”) Registration Statement on Form S-1 (File No. 333-232276) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representative of the underwriters hereby join the request of Obalon Therapeutics, Inc. that the effectiveness of the above-referenced Registration Statement be accelerated to 5:00 p.m. (EDT) on August 1, 2019, or as soon thereafter as is practicable, or at such other time as the Company or its outside counsel, Latham & Watkins LLP, may orally request via telephone call to the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission. Pursuant to Rule 460 under the Act, please be advised that there will be distributed to each underwriter or dealer who is reasonably anticipated to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We further advise you that we have complied and will continue to comply, and that we have been informed by the participating underwriters and dealers that they have complied and will continue to comply, with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, A.G.P./Alliance Global Partners As the Representative of the Underwriters By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2019-07-30 - CORRESP - Vyome Holdings, Inc
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Document
Obalon Therapeutics, Inc.
5421 Avenida Encinas, Suite F
Carlsbad, California 92008
July 30, 2019
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-6010
Attention: Thomas Jones, Russell Mancuso
Re:
Obalon Therapeutics, Inc. Registration Statement on Form S-1 (Registration No. 333-232276)
Ladies and Gentlemen:
In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-1 (File No. 333-232276) (the “Registration Statement”) of Obalon Therapeutics, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 5:00 p.m., Eastern Time, on August 1, 2019, or as soon as practicable thereafter, or at such other time as our legal counsel, Latham & Watkins LLP, may orally request via telephone call to the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Shayne Kennedy at (714) 755-8181 or, in his absence, Benjamin Sosin at (714) 755-2267.
Thank you for your assistance in this matter.
Very truly yours,
OBALON THERAPEUTICS, INC.
By: /s/ William Plovanic
William Plovanic
President and Chief Financial Officer
CC:
B. Shayne Kennedy, Latham & Watkins LLP
Merrill M. Kraines, Pepper Hamilton LLP
2019-07-17 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm Document VIA EDGAR Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Thomas Jones, Russell Mancuso Re: Obalon Therapeutics, Inc. Registration Statement on Form S-1 Filed June 21, 2019 File No. 333-232276 Ladies and Gentlemen: On behalf of our client, Obalon Therapeutics, Inc., a Delaware corporation (the “Company”), and pursuant to the applicable provisions of the Securities Act of 1933, as amended (the “Securities Act”), and the rules promulgated thereunder, please find enclosed the Company’s proposed revisions to the above-captioned Registration Statement on Form S-1 (the “Registration Statement”), which was filed with the Securities and Exchange Commission (the “Commission”) on June 21, 2019 (the “Filing”). The enclosed Exhibit A reflect certain proposed revisions to the section of the Registration Statement titled “Risk Factors—Risks Related to This Offering and Ownership of our Common Stock,” as a response to the comment letter from the staff of the Commission (the “Staff”) to Mr. Plovanic, the Company’s President and Chief Financial Officer, dated July 16, 2019. Exhibit A is marked to show the differences between the proposed revisions and the applicable disclosure from the Filing. July 17, 2019 Page 2 The numbered paragraph in italics below set forth the Staff’s comment together with the response. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in the Registration Statement. Our restated certificate of incorporation designates the Court of Chancery of the State of Delaware, page 70 1. We note that your forum selection provision identifies the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation, including any "derivative action." Please disclose whether this provision applies to actions arising under the Securities Act or Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. If the provision applies to Securities Act claims, please alsorevise your prospectus to state that there is uncertainty as to whether a court would enforce such provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Response: In response to the Staff’s comment, the Company proposes to revise the disclosure on page 70 of the Registration Statement as reflected on Exhibit A hereto. July 17, 2019 Page 3 We look forward to resolving any outstanding issues with respect to the Registration Statement as quickly as possible. Please do not hesitate to contact me at (714) 755-8181 with any questions or further comments you may have regarding the Registration Statement or if you wish to discuss the above or enclosed. Sincerely, /s/ B. Shayne Kennedy B. Shayne Kennedy of LATHAM & WATKINS LLP Enclosures cc: (via e-mail) William Plovanic, President and Chief Financial Officer, Obalon Therapeutics, Inc. Drew Capurro, Latham & Watkins LLP Merrill M. Kraines, Pepper Hamilton LLP Thomas E. Mitchell, Pepper Hamilton LLP July 17, 2019 Exhibit A Comparison of Proposed Revisions against Filing Registration Statement, page 70 Our restated certificate of incorporation designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents. Our restated certificate of incorporation provides that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers, employees or agents to us or our stockholders, any action asserting a claim arising pursuant to any provision of the DGCL, our restated certificate of incorporation or our restated bylaws or any action asserting a claim that is governed by the internal affairs doctrine, in each case subject to the Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein and the claim not being one which. Notwithstanding the foregoing, this provision will not apply to any claims arising under the Securities Act or the Exchange Act, or any claim in which exclusive jurisdiction is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery or for which the Court of Chancery does not have subject matter jurisdiction. Any person purchasing or otherwise acquiring any interest in any shares of our capital stock shall be deemed to have notice of and to have consented to this provision of our restated certificate of incorporation. This choice of forum provision may limit our stockholders’ ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, employees or agents, which may discourage such lawsuits against us and our directors, officers, employees and agents even though an action, if successful, might benefit our stockholders. Stockholders who do bring a claim in the Court of Chancery could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Delaware. The Court of Chancery may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments or results may be more favorable to us than to our stockholders. Alternatively, if a court were to find this provision of our restated certificate of incorporation inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could have a material adverse effect on our business, financial condition or results of operations.
2019-07-16 - UPLOAD - Vyome Holdings, Inc
July 16, 2019
William Plovanic
President and Chief Financial Officer
Obalon Therapeutics, Inc.
5421 Avenida Encinas, Suite F
Carlsbad, California 92008
Re:Obalon Therapeutics, Inc.
Registration Statement on Form S-1
Filed June 21, 2019
File No. 333-232276
Dear Mr. Plovanic:
We have limited our review of your registration statement to those issues we have
addressed in our 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.
Form S-1 filed June 21, 2019
Our restated certificate of incorporation designates the Court of Chancery of the State of
Delaware, page 70
1.We note that your forum selection provision identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any "derivative
action." Please disclose whether this provision applies to actions arising under the
Securities Act or Exchange Act. In that regard, we note that Section 27 of the Exchange
Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or
liability created by the Exchange Act or the rules and regulations thereunder, and Section
22 of the Securities Act creates concurrent jurisdiction for federal and state courts over
all suits brought to enforce any duty or liability created by the Securities Act or the rules
and regulations thereunder. If the provision applies to Securities Act claims, please also
FirstName LastNameWilliam Plovanic
Comapany NameObalon Therapeutics, Inc.
July 16, 2019 Page 2
FirstName LastName
William Plovanic
Obalon Therapeutics, Inc.
July 16, 2019
Page 2
revise your prospectus to state that there is uncertainty as to whether a court would
enforce such provision and that investors cannot waive compliance with the federal
securities laws and the rules and regulations thereunder.
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 Thomas Jones at 202-551-3602 or Russell Mancuso, Branch Chief, at 202-
551-3617 with any questions.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: B. Shayne Kennedy
2019-02-11 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm Document Obalon Therapeutics, Inc. 5421 Avenida Encinas, Suite F Carlsbad, CA 92008 February 11, 2019 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attention: Michael Fay Re: Obalon Therapeutics, Inc. Registration Statement on Form S-1, as amended File No. 333-229142 Dear Mr. Fay: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned, Obalon Therapeutics, Inc., a Delaware corporation (the “Registrant”), hereby request acceleration of the effective date of the Registration Statement referred to above, as amended to date, so that it may become effective at 4:30 p.m. Eastern Standard Time on February 13, 2019, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling B. Shayne Kennedy at (714) 755-8181. Thank you for your assistance in this matter. Very truly yours, OBALON THERAPEUTICS, INC., a Delaware corporation By: _/s/ William Plovanic_____________________ Name: William Plovanic Title: Chief Financial Officer cc: B. Shayne Kennedy, Latham & Watkins LLP
2019-02-08 - UPLOAD - Vyome Holdings, Inc
February 6, 2019
Kelly Huang
President and Chief Executive Officer
Obalon Therapeutics, Inc.
5421 Avenida Encinas, Suite F
Carlsbad, CA 92008
Re:Obalon Therapeutics, Inc.
Registration Statement on Form S-1
Filed January 4, 2019
File No. 333-229142
Dear Dr. Huang:
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 Michael Fay at 202-551-3812 with any questions.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: B. Shayne Kennedy, Esq.
2018-09-12 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm Document Obalon Therapeutics, Inc. 5421 Avenida Encinas, Suite F Carlsbad, CA 92008 September 12, 2018 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attention: Heather Percival Re: Obalon Therapeutics, Inc. Registration Statement on Form S-3 Filed August 31, 2018 File No. 333-227160 Dear Ms. Percival: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned, Obalon Therapeutics, Inc., a Delaware corporation (the “Registrant”), hereby request acceleration of the effective date of the Registration Statement referred to above so that it may become effective at 5:00 p.m. Eastern Standard Time on September 14, 2018, or as soon as practicable thereafter. We acknowledge the following: • should the Securities and Exchange Commission (the “Commission”) or its 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 staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • 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. We appreciate your assistance in this matter. Very truly yours, OBALON THERAPEUTICS, INC., a Delaware corporation By: /s/ William Plovanic Name: William Plovanic Title: Chief Financial Officer cc: B. Shayne Kennedy, Latham & Watkins LLP
2018-09-11 - UPLOAD - Vyome Holdings, Inc
September 11, 2018
Andrew Rasdal
Chief Executive Officer
Obalon Therapeutics, Inc.
5421 Avenida Encinas, Suite F
Carlsbad, California 92008
Re:Obalon Therapeutics, Inc.
Registration Statement on Form S-3
Filed August 31, 2018
File No. 333-227160
Dear Mr. Rasdal:
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 Heather Percival at 202-551-3498 with any questions.
Sincerely,
Division of Corporation Finance
Office of Electronics and Machinery
cc: B. Shayne Kennedy
2017-11-17 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm Document Obalon Therapeutics, Inc. 5421 Avenida Encinas, Suite F Carlsbad, CA 92008 November 17, 2017 VIA EDGAR The Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attn: Heather Percival Re: Obalon Therapeutics, Inc. Registration Statement on Form S-3 Filed November 1, 2017 File No. 333-221264 Dear Ms. Percival: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned, Obalon Therapeutics, Inc., a Delaware corporation (the “Registrant”), hereby requests acceleration of the effective date of the Registration Statement referred to above so that it may become effective at 5:00 p.m. Eastern Standard Time on November 17, 2017, or as soon thereafter as practicable. We acknowledge the following: • should the U.S. Securities and Exchange Commission (the “Commission”) or its 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 staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • 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. We appreciate your assistance in this matter. Securities and Exchange Commission November 17, 2017 Page 2 Very truly yours, OBALON THERAPEUTICS, INC., a Delaware corporation By: /s/ William Plovanic Name: William Plovanic Title: Chief Financial Officer cc: B. Shayne Kennedy, Esq., Latham & Watkins LLP
2017-11-14 - UPLOAD - Vyome Holdings, Inc
Mail Stop 3030 November 14, 2017 Via E -mail Andrew Rasdal Chief Executive Officer Obalon Therapeutics, Inc. 5421 Avenida Encinas, Suite F Carlsbad, California 92008 Re: Obalon Therapeutics, Inc. Registration Statement on Form S-3 Filed November 1, 2017 File No. 333-221264 Dear Mr. Rasdal : 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 Heather Percival at (202) 551 -3498 with any questions. Sincerely, /s/ Heather Percival for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: B. Shayne Kennedy Latham & Watkins LLP
2016-10-03 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm CORRESP October 3, 2016 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Obalon Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-213551) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters (the “Underwriters”), hereby join in the request of Obalon Therapeutics, Inc. with respect to the effective time of the above-referenced Registration Statement so that it will become effective Wednesday, October 5, 2016, at 4:00 p.m. Eastern Time, or as soon thereafter as practicable. In connection with this acceleration request and pursuant to Rule 460 under the Act, please be advised that, during the period from September 26, 2016 to the date of this letter, we have effected approximately the following distribution of copies of the preliminary prospectus, dated September 26, 2016: To Whom Distributed Number of Copies Institutions, Brokers and Other 1948 We, the undersigned, as representatives of the several Underwriters, have complied and will comply, and we have been informed by the participating Underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. [signature page follows] Very truly yours, UBS SECURITIES LLC CANACCORD GENUITY INC. STIFEL, NICOLAUS & COMPANY, INCORPORATED on behalf of themselves and as representatives of the Underwriters UBS SECURITIES LLC By: /s/ John Hagens Name: John Hagens Title: Executive Director By: /s/ Evan Demcoe Name: Evan Demcoe Title: Associate Director CANACCORD GENUITY INC. By: /s/ Jeffrey G. Barlow Name: Jeffrey G. Barlow Title: President, Canaccord Genuity Inc. (U.S.) STIFEL, NICOLAUS & COMPANY, INCORPORATED By: /s/ Keith Lister Name: Keith Lister Title: Managing Director [Signature Page to Underwriters’ Acceleration Request Letter]
2016-10-03 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm CORRESP OBALON THERAPEUTICS, INC. 5421 Avenida Encinas, Suite F Carlsbad, California 92008 October 3, 2016 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Amanda Ravitz Geoff Kruczek Caleb French Kate Tillan Tara Harkins Re: Obalon Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-213551) filed September 9, 2016, as amended Requested Date: October 5, 2016 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: Obalon Therapeutics, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statement on Form S-1 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes Robert Freedman or Amanda Rose, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant hereby acknowledges 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 Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Registrant may not assert the 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. The Registrant requests that it be notified of such effectiveness by a telephone call to Mr. Freedman at (650) 335-7292 or in his absence, Ms. Rose at (206) 389-4553. Sincerely, OBALON THERAPEUTICS, INC. By: /s/ William Plovanic William Plovanic Chief Financial Officer cc: Andrew Rasdal, Chief Executive Officer Obalon Therapeutics, Inc. Robert Freedman, Esq. Amanda Rose, Esq. Fenwick & West LLP
2016-09-26 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm CORRESP September 26, 2016 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Amanda Ravitz Geoff Kruczek Caleb French Kate Tillan Tara Harkins Re: Obalon Therapeutics, Inc. Registration Statement on Form S-1 Filed September 9, 2016 File No. 333-213551 Ladies and Gentlemen: We are submitting this letter on behalf of Obalon Therapeutics, Inc. (the “Company”) in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by electronic mail dated September 20, 2016 relating to the Company’s Registration Statement on Form S-1 (File No. 333-213551) filed with the Commission on September 9, 2016 (the “Registration Statement”). The numbered paragraphs below correspond to the numbered comments in the Staff’s letter and the Staff’s comments are presented in bold italics. We have also enclosed with the copy of this letter that is being transmitted via overnight delivery five copies of Amendment No. 1 to the Registration Statement in paper format, which have been marked to show changes from the Registration Statement as filed on September 9, 2016. In addition to addressing the comments raised by the Staff in its letter, the Company has revised the Registration Statement to include the 2.90-to-1 reverse stock split and the anticipated price range for the initial public offering. Use of Proceeds, page 57 1. We note your response to prior comment 8. Given your disclosure regarding the different uses of the offering’s proceeds, please revise to clarify the approximate amount intended to be used for each purpose listed here. In response to the Staff’s comment, the Company has revised its disclosure on page 57 of the Registration Statement. U.S. Securities and Exchange Commission September 26, 2016 Page 2 Dilution, page 62 2. Please expand your revisions added in response to prior comment 9 to disclose how the amounts and percentages under the heading “Total consideration” would change assuming the exercise of all outstanding warrants and options. In response to the Staff’s comment, the Company has revised its disclosure on page 64 of the Registration Statement. Recently developed treatment alternatives, page 86 3. In addition to the one-year weight loss data you added in response to prior comment 19, please address that portion of the comment that asked you to disclose the data relating to the amount of pounds lost during your competitors’ trials. Ensure that your disclosure is clear regarding how those amounts compare to the amount lost during and as of completion of those trials, as well as during any follow-up subsequent to those trials. In response to the Staff’s comment, the Company has revised its disclosure on page 87 of the Registration Statement to provide the amount of pounds lost at the end of the six-month treatment period of each of the trials of the Company’s competitors, in addition to the total amount of pounds lost at the end of the six-month period following balloon removal (which was 12 months following the initial balloon placement). Sales and Marketing, page 96 4. Given your disclosed reliance on your distribution agreement with Bader for all of your current revenues, please address that portion of prior comment 21 that asked you to revise your disclosure to indicate the minimum purchase requirements under the agreement. In response to the Staff’s comment, the Company has revised its disclosure on page 97 of the Registration Statement to provide Bader’s 2016 and 2017 minimum purchase obligations. The Company respectfully advises the Staff that Bader’s minimum purchase obligations beyond 2017 are speculative and may be amended in the future based on business developments. Additionally, as noted on pages 68 and 69 of the Registration Statement, the Company expects that sales to Bader will constitute a significantly smaller percentage of its total revenue in the future as it plans to commence commercial sales of its product in the United States in 2017. Therefore, the Company believes Bader’s minimum purchase obligations beyond 2017 are not material to investors, and disclosure of such terms may cause investors to overestimate their importance or make estimates about future revenue that are not accurate. U.S. Securities and Exchange Commission September 26, 2016 Page 3 Exhibits 5. Please ensure that all exhibits filed are complete. For example, we note that exhibits 4.4, 4.5, and 4.6 refer to an attached capitalization table and exhibits 4.5 and 4.6 refer to Appendix 1, none of which appear to be attached. Also, exhibits C and D to exhibit 10.10 refer to a “New Borrower Kit,” but those documents do not appear to be attached. The Company advises the Staff that it has reviewed all original versions of the documents filed as exhibits, including the exhibits referenced in the Staff’s comment, and such original versions of the documents did not contain any exhibits, appendixes or other attachments that were not included in the version of such document filed as an exhibit to the Registration Statement. The references to the attached capitalization tables, Appendix 1 and the “New Borrower Kit” referenced in the Staff’s comment were either erroneous references or were never delivered in connection with the final document and are not included in the original record. ***** Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (650) 335-7292. Sincerely, /s/ Robert Freedman Robert Freedman cc: Andrew Rasdal, Chief Executive Officer William Plovanic, Chief Financial Officer Obalon Therapeutics, Inc. Robert Freedman, Esq. Matthew Rossiter, Esq. Amanda Rose, Esq. Fenwick & West LLP Shayne Kennedy, Esq. Keith Halverstam, Esq. Richard Kim, Esq. Latham & Watkins LLP
2016-09-20 - UPLOAD - Vyome Holdings, Inc
Mail Stop 3030 September 20, 2016 Via E -mail Andrew Rasdal President and Chief Executive Officer Obalon Therapeutics, Inc. 5421 Avenida Encinas, Suite F Carlsbad, CA 92008 Re: Obalon Therapeutics, Inc. Registration Statement on Form S -1 Filed September 9, 2016 File No. 333 -213551 Dear Mr. Rasdal : 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 no t 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. Unless we note otherwise, our references to prior comments are to comments in our August 31, 2016 letter. Use of Proceeds, page 57 1. We note your response to prior comment 8. Given your disclosure regarding the different uses of the offering’s proceeds, please revise to clarify the approximate amount intended to be used for each purpose listed here. Andrew Rasdal Obalon Therapeutics, Inc. September 20, 2016 Page 2 Dilution, page 62 2. Please expand your revisions added in response to prior comment 9 to disclose how the amounts and percentages under the heading “Total consideration” would change assuming the exercise of all outstanding warrants and options. Recently developed treatment alternatives, page 86 3. In addition to the one -year weight loss data you added in response to prior comment 19, please address that po rtion of the comment that asked you to disclose the data relating to the amount of pounds lost during your competitors’ trials. Ensure that your disclosure is clear regarding how those amounts compare to the amount lost during and as of completion of thos e trials, as well as during any follow -up subsequent to those trials. Sales and Marketing, page 96 4. Given your disclosed reliance on your distribution agreement with Bader for all of your current revenues, please address that portion of prior comment 21 that asked you to revise your disclosure to indicate the minimum purchase requirements under the agreement. Exhibits 5. Please ensure that all exhibits filed are complete. For example, we note that exhibits 4.4, 4.5, and 4.6 refer to an attach ed capitalization table and exhibits 4.5 and 4.6 refer to Appendix 1 , none of which appear to be attached. Also, exhibits C and D to exhibit 10.10 refer to a “New Borrower Kit,” but those documents do not appear to be attached. 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 regi stration 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 acti on with respect to the filing; Andrew Rasdal Obalon Therapeutics, Inc. September 20, 2016 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 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. You may contact Tara Harkins at (202) 551 -3639 or Kate Tillan, Assistant Chief Accountant, at (202) 551 -3604 if you have questions regarding comments on the financial statements and related matters. Please contact Caleb French at (202) 551 -6947 or Geoff Kruczek, Senior Attorney, at (202) 551 -3641 with any other questions. Sincerely, /s/ Geoff Kruczek for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Robert A. Freedman, Esq. Fenwi ck & West LLP
2016-09-16 - CORRESP - Vyome Holdings, Inc
CORRESP
1
filename1.htm
CORRESP
555 CALIFORNIA STREET, 12TH FLOOR SAN FRANCISCO CA, 94104
TEL 451.875.2300 FAX 415.281.1350 WWW.FENWICK.COM
September 16, 2016
CERTAIN PORTIONS OF THIS LETTER AS FILED VIA EDGAR HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED FOR THE OMITTED PORTIONS, WHICH HAVE BEEN REPLACED WITH THE FOLLOWING PLACEHOLDER: “[***].”
VIA EDGAR AND OVERNIGHT
DELIVERY
Securities and Exchange Commission
Division
of Corporation Finance
100 F Street, NE Washington, DC 20549
Attention:
Amanda Ravitz
Geoff Kruczek
Caleb French
Kate Tillan
Tara Harkins
Re:
Obalon Therapeutics, Inc.
Registration Statement on Form S-1
Filed
September 9, 2016
File No. 333-213551
Ladies and Gentlemen:
On
behalf of Obalon Therapeutics, Inc. (the “Company”), and in response to a comment from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
contained in your letter dated August 31, 2016 (the “Comment Letter”), relating to the above-referenced Registration Statement on Form S-1 (the “Registration Statement”), we submit this
supplemental letter to address comment 17 of the Comment Letter concerning the significant factors contributing to the difference between the fair value as of the date of grant and the estimated initial public offering
(“IPO”) price for options granted during the six months prior to the date of the most recent balance sheet. In this letter, we have recited comment 17 from the Staff in italicized, bold type and have followed the comment with
the Company’s response. For the convenience of the Staff, we are providing to the Staff by overnight delivery copies of this letter.
Because of the
commercially sensitive nature of information contained herein, this submission is accompanied by the Company’s request for confidential treatment of selected portions of this letter pursuant to Rule 83 of the Commission’s
Rules on Information and Requests, 17 C.F.R. § 200.83 and the Freedom of Information Act.
CONFIDENTIAL TREATMENT
REQUESTED BY OBALON THERAPEUTICS, INC.
OBALON - 1
Securities and Exchange Commission
Division of Corporation Finance
September 16, 2016
Page
2
17.
We note that you disclosed a placeholder for the aggregate intrinsic value of all outstanding options based on the midpoint of the estimated IPO price range. Please include an updated discussion of each
significant factor contributing to the difference between the fair value as of the date of grant and the estimated IPO price for options granted during the six months prior to the date of the most recent balance sheet once you have determined your
IPO price range.
The Company advises the Staff that the Company currently anticipates that it will include an expected price range
in its preliminary prospectus (the “Preliminary Prospectus”) for the proposed IPO that will be between $ [***] and $[***] per share before effecting a proposed [***] to 1 reverse stock split (the “Price
Range”). The Company anticipates effecting the reverse stock split in connection with its IPO pursuant to a future amendment of the Company’s certificate of incorporation that will be filed with the Secretary of State of the State
of Delaware before filing the Preliminary Prospectus with the Commission (the “Stock Split”). The share numbers and stock prices set forth in this letter do not reflect the Stock Split. On a post-Stock Split basis, the spread
of the actual price range included in the Preliminary Prospectus will be no more than $2.00, if the maximum price is $10.00 per share or less, or 20%, if the maximum price is greater than $10.00 per share. The Price Range has been determined based,
in part, upon current market conditions, recent public offerings of other comparable companies and input received from the lead underwriters of the proposed offering, including discussions that took place on September 14, 2016 between the
Company and representatives of UBS Securities LLC, Canaccord Genuity Inc. and Stifel, Nicolaus & Company, Incorporated, the lead underwriters.
Prior to September 14, 2016, the Company had not held formal discussions with the underwriters regarding a price range for the IPO. The Price Range does
not take into account the current lack of liquidity for the Company’s common stock and assumes a successful IPO as of the date of that discussion with no weighting attributed to any other outcome for the Company’s business, such as
remaining a privately held company.
We supplementally advise the Staff that, as previously described in response to comment 15 of the Comment Letter,
with respect to the option grants identified in the table below, the Company’s board of directors (the “Board”), with the assistance of management, determined the fair value of the Company’s common stock on each
grant date in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The fair value of the Company’s common
stock on the date of grant was determined by taking into account several factors, including the following:
•
contemporaneous valuations performed by unrelated third-party specialists;
•
existing indebtedness;
•
rights, preferences and privileges of the Company’s convertible preferred stock relative to those of the Company’s common stock;
•
actual operating and financial performance;
•
present value of future cash flows;
CONFIDENTIAL TREATMENT
REQUESTED BY OBALON THERAPEUTICS, INC.
OBALON - 2
Securities and Exchange Commission
Division of Corporation Finance
September 16, 2016
Page
3
•
likelihood of achieving a liquidity event, such as an initial public offering or a sale of the Company;
•
prevailing market conditions and the nature and history of the Company’s business;
•
illiquidity of stock-based awards involving securities in a private company;
•
experience of the Company’s management team;
•
market multiples of comparable companies in the Company’s industry;
•
stage of development of the Company;
•
industry information such as market size and growth; and
•
macroeconomic conditions.
For purposes of the third-party valuations, the per share common stock value
resulted from a methodology that first estimated the fair value of the business as a whole by taking the Company’s business enterprise value and adding the Company’s cash balance as of the valuation date, or total invested capital, and
then allocating the total invested capital to the common stock based on using a separate methodology. The resulting value was then further adjusted using a rate that accounts for lack of marketability considering that the Company’s stockholders
cannot freely trade the common stock in the public markets. The Board determined that the assumptions and inputs used in connection with any third-party valuations reflected the Board’s and management’s best estimate of the business
condition, prospects and operating performance of the Company at each valuation date.
The following table summarizes the stock option grants that have
been made since January 1, 2016:
Award Date
Options Granted
Fair Value
of
Common
Stock/Exercise Price
of Option
February 5, 2016
97,000
$0.32
March 9, 2016
75,000
$0.32
March 24, 2016
456,662
$0.32
May 11, 2016
854,000
$0.61
July 27, 2016
655,675
$0.97
August 3, 2016
10,000
$0.97
With respect to the stock options granted during the six months ended June 30, 2016, we refer the Staff to the
Company’s response to comment 15 of the Comment Letter, in which the Company previously provided the Staff with its analysis of how the Company determined the underlying fair value of its common stock on the grant date of such options and the
reasons for the increase in fair value during that period.
We supplementally advise the Staff as follows with respect to the July 27, 2016 and
August 3, 2016 stock option grants.
CONFIDENTIAL TREATMENT
REQUESTED BY OBALON THERAPEUTICS, INC.
OBALON - 3
Securities and Exchange Commission
Division of Corporation Finance
September 16, 2016
Page
4
June 30, 2016 Valuation Report
The Board obtained a third-party valuation report that estimated the fair value of the Company’s common stock as of June 30, 2016 was $0.97 per share
(the “June 2016 Valuation Report”). For purposes of the June 2016 Valuation Report, the total invested capital was estimated utilizing a combination of an estimate of the future IPO value of the Company and the Company’s
recently completed Series E financing in April 2016. The total invested capital was then allocated to the Company’s common stock using a combination of the Option Pricing Method (“OPM”) and Probability-Weighted
Expected-Return Method (“PWERM”), which is referred to as the Hybrid Method. The Hybrid Method combines the PWERM and OPM in a single framework. The Hybrid Method included a PWERM for the June 30, 2016 valuation date
because an IPO became a possible liquidity event and the Company was beginning to prepare for a potential IPO. The PWERM incorporated probability estimates for a potential IPO scenario, contemplating both an early IPO scenario in December 2016
(probability weighted at 6% with a Discount for Lack of Marketability (“DLOM”) of 15%) and a late IPO scenario in March 2017 (probability weighted at 14% with a DLOM of 15%), and a non-IPO scenario in which the Company
remained a private company (probability weighted at 80% with a DLOM of 25%). As the DLOM is a measure of marketability that considers the length of time to a liquidity event, the DLOM associated with the IPO scenario is lower as the liquidity event,
or the IPO, is contemplated to occur within a shorter period of time compared to a liquidity event in a non-IPO scenario. The following factors were taken into account when establishing the assigned probability of the IPO scenario:
•
The Company was awaiting an update from the U.S. Food and Drug Administration (“FDA”) regarding its premarket approval (“PMA”) submission and related timing of approval,
which it did not yet have. The Company did not receive PMA approval until September 8, 2016. In addition, as of June 30, 2016, the approval process was expected to take an additional six months based on the historical FDA review period of
approved products of other gastric balloon companies.
•
The Company was an early stage medical device company with less revenue from existing products in the six months ended June 30, 2016 than in the six months ended June 30, 2015 and did not yet have a product
approved for sale in the United States.
•
The potential for a lack of investor interest in the Company’s initial public offering given that medical device companies are valued in part based on their ability to generate revenue, and the Company had limited
revenue and no approved product in the United States at that time.
•
The market for small capitalization stocks and emerging growth companies continued to experience volatility.
Stock Options Granted on July 27, 2016 and August 3, 2016
As set forth in the table above, the Board granted stock options on July 27, 2016 and August 3, 2016 with exercise prices equal to $0.97 per share,
which the Board determined to be the fair value of common stock on each grant date. In order to make this determination, the Board reviewed the June 2016 Valuation Report and considered the fact that, from June 30, 2016 to each grant date,
there had been no significant corporate events or developments or additional equity sales. Given the lack of significant developments in the Company’s PMA submission and the fact that no additional capital raising transactions had occurred, in
the judgment of the Board, there were no internal or external developments that would indicate that the fair value of the common stock had changed from June 30, 2016
CONFIDENTIAL TREATMENT
REQUESTED BY OBALON THERAPEUTICS, INC.
OBALON - 4
Securities and Exchange Commission
Division of Corporation Finance
September 16, 2016
Page
5
for the grants on July 27 and August 3, 2016. As a result, no additional third-party valuation was completed subsequent to the June 2016 Valuation Report. The Company has not granted,
and does not anticipate granting, any additional options subsequent to those granted on August 3, 2016.
Comparison of IPO Price Range and Recent
Fair Value Determination
We are supplementally providing the Staff the following discussion regarding the significant factors contributing to the
difference between the Price Range and the estimated fair values of the Company’s common stock reflected in the table above.
We note that, as is
typical in IPOs, the estimated Price Range for this offering was not derived using a formal determination of fair value, but was determined by negotiation between the Company and the underwriters. Among the factors that were considered in setting
this range were the following:
•
an analysis of the typical valuation ranges seen in recent IPOs for companies in our industry;
•
the general condition of the securities markets and the recent market prices of, and the demand for, publicly traded common stock of generally comparable companies;
•
an assumption that there would be a receptive public trading market for a commercial stage medical device company such as the Company; and
•
an assumption that there would be sufficient demand for the Company’s common stock to support an offering of the size contemplated by this prospectus.
Specifically, the Company believes the differences between the fair value of its common stock determined for the stock options granted since January 1,
2016 and the Price Range are due primarily to the fact that in September 2016, the Company received PMA approval from the FDA to market and sell its product in the United States, as well as the following additional factors:
•
The Company’s April 2016 Series E preferred stock financing, which included both new and existing investors in the Company, all of which were sophisticated investors with well-informed views of the
then-current financing environment for both public and private medical device companies, including those in the obesity industry. These investors had engaged in robust, arms-length negotiations with the Company that involved extensive diligence and
price and value discovery discussions. This financing had not occurred, and therefore these discussions and resulting valuation were appropriately not included in the determinations of fair value prior to April 2016.
•
Early IPO preparations had not begun prior to June 2016, and therefore were appropriately not considered in connection with the determinations of fair value prior to July 2016, but were considered in connection with the
fair value determinations in July and August 2016.
•
New developments in the Company’s business, including, as noted above, the fact that in September 2016, the Company received PMA approval from the FDA to market and sell its product in the United States and
anticipates commencing the U.S. commercial launch of its product in early 2017, which was appropriately not taken into account in the Board’s historical determinations of fair value but was in determining the Price Range.
CONFIDENTIAL TREATMENT
REQUESTED BY OBALON THERAPEUTICS, INC.
OBALON - 5
Securities and Exchange Commission
Division of Corporation Finance
September 16, 2016
Page
6
•
Differences in the valuation methodologies, assumptions and inputs used by the underwriters in their valuation analysis discussed with the Company and used to determine the Price Range, which assume a successful IPO as
of today’s date with no probability weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company, compared to the valuation methodologies, assumptions an
2016-09-08 - CORRESP - Vyome Holdings, Inc
CORRESP 1 filename1.htm CORRESP September 9, 2016 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Amanda Ravitz Geoff Kruczek Caleb French Kate Tillan Tara Harkins Re: Obalon Therapeutics, Inc. Draft Registration Statement on Form S-1 Submitted August 4, 2016 CIK No. 0001427570 Ladies and Gentlemen: We are submitting this letter on behalf of Obalon Therapeutics, Inc. (the “Company”) in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by electronic mail dated August 31, 2016 relating to the Company’s draft Registration Statement on Form S-1 (CIK No. 0001427570) confidentially submitted to the Commission on August 4, 2016 (the “Registration Statement”). The Registration Statement is being publicly filed concurrently herewith. The numbered paragraphs below correspond to the numbered comments in the Staff’s letter and the Staff’s comments are presented in bold italics. We have also enclosed with the copy of this letter that is being transmitted via overnight delivery five copies of the Registration Statement in paper format, which have been marked to show changes from the draft Registration Statement as originally submitted. In addition to addressing the comments raised by the Staff in its letter, the Company has revised the Registration Statement to update other disclosures, including the U.S. Food and Drug Administration’s (“FDA”) recent approval of its Obalon balloon system. Prospectus Summary, page 1 The Obesity Epidemic, page 1 1. Please revise to clarify what you mean by “medical costs associated with obesity.” If this phrase includes costs related to the effects of obesity, rather than merely related to U.S. Securities and Exchange Commission September 9, 2016 Page 2 the treatment for obesity, please revise to clarify. Also revise to clarify what portion of that amount relates to the treatment of obesity. The Company advises the Staff that the amount of medical costs associated with obesity as disclosed on pages 2, 83 and 85 of the Registration Statement reflects the medical costs related to the effects of obesity, which may include treatment costs. The amount was determined by comparing all medical expenditures attributable to obesity, including out of pocket expenses, third-party payer expenses and Medicaid, for people who are obese versus people who are not obese. The Company has been unable to find a reliable statistic to quantify the amount spent directly on obesity treatments. In response to the Staff’s comment, the Company has revised its disclosure on pages 2, 83 and 85 of the Registration Statement to clarify that the number disclosed reflects the national medical care costs of obesity-related illness in adults, including out of pocket expenses, third-party payer expenses and Medicaid. Our Solution, page 2 Favorable Safety Profile, page 2 2. Please reconcile your disclosure here that all the reported serious adverse device events from your product occurred when the product was not used according to approved labelling with your disclosure in the first full paragraph on page 16 which indicates that in one instance you could not obtain enough information to verify an injury’s cause. The Company respectfully advises the Staff that even in the instance in which the Company could not obtain enough information to verify the exact cause of injury as described on page 16 of the Registration Statement, the Company did have enough information in that instance to confirm that the product was not used in accordance with approved labeling. In response to the Staff’s comment, the Company has clarified the nature of the information it was unable to verify on page 16 of the Registration Statement. Simple and Convenient Placement, page 2 3. If you believe it is appropriate to highlight the fact that your product can be placed without anesthesia or an endoscopy, please also provide disclosure, such as that found on page 4, indicating that removal of your product does require an endoscopy and sedation. In response to the Staff’s comment, the Company has revised its disclosure on pages 3, 84 and 88 of the Registration Statement. Implications of Being an Emerging Growth Company, page 6 4. 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 U.S. Securities and Exchange Commission September 9, 2016 Page 3 behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. In response to the Staff’s comment, the Company will provide to the Staff on a supplemental basis under separate cover copies of all written materials that the Company, or anyone authorized to do so on the Company’s behalf, presented to potential investors in reliance on Section 5(d) of the Securities Act of 1933, as amended. Summary Consolidated Financial Data, page 9 5. We note on page 10 and throughout the filing that you have presented pro forma adjustments relating to the automatic conversion of all the outstanding shares of your convertible preferred stock into common stock and ultimately the automatic conversion of your outstanding preferred warrants to purchase common stock. We further note from pages F-43 and F-44 that all of the preferred stock is automatically converted into common stock upon the company’s sale of your common stock in a firm commitment underwritten public offering in which the per share is price is at least $4.29. Explain to us why you believe these pro forma adjustments related to the conversion of your preferred shares upon the initial public offering are factually supportable by confirming to us that you presently expect the offering to meet such conditions. If management subsequently concludes the conditions may not be satisfied, please revise the filing accordingly. As the Staff notes, per the terms of the Company’s certificate of incorporation, all shares of the Company’s outstanding convertible preferred stock will automatically convert to common stock immediately prior to the closing of the Company’s initial public offering, provided that the offering price per share in the Company’s initial public offering is at least $4.29 and the aggregate gross proceeds to the Company in such offering is at least $30.0 million. The Company currently expects the price and aggregate gross proceeds will meet such conditions. If at a future date, however, the Company determines that the price and proceeds may not meet such conditions, then the Company will seek consent from the holders of at least 67% of the outstanding preferred stock (representing the requisite percentage under the Company’s certificate of incorporation) to automatically convert all shares of convertible preferred stock to common stock, effectively immediately prior to the closing of the initial public offering. In such case, the Company will update the disclosure in the Registration Statement to note that the requisite 67% of preferred stock holders have consented to the automatic conversion of convertible preferred stock to common stock immediately prior to the closing of the initial public offering. With respect to the automatic conversion of preferred stock warrants to common stock warrants, the Company respectfully refers the Staff to its response to comment 6 below. U.S. Securities and Exchange Commission September 9, 2016 Page 4 6. Explain to us why you believe that the outstanding preferred stock warrants and other warrants will be ultimately converted into common stock upon the initial public offering and are directly attributable to the transaction and factually supportable. The Company advises the Staff that the treatment of outstanding warrants upon the initial public offering is determined pursuant to the terms of each warrant. Certain of the Company’s outstanding warrants to purchase preferred stock contain provisions pursuant to which they will automatically convert to warrants to purchase common stock immediately prior to the closing of the initial public offering, and the other warrants to purchase preferred stock contain provisions pursuant to which they will automatically be deemed to have been net exercised immediately prior to the closing of the initial public offering based on the initial public offering price per share. The Company has clarified on pages 8 and 138 of the Registration Statement that this treatment occurs pursuant to the terms of the warrants, each of which is filed as an exhibit to the Registration Statement. Risk Factors, page 11 7. Given your disclosure on pages 52 and 130, please revise to clarify whether you will be a controlled company under applicable exchange rules and, if so, whether that status creates material risks. Also revise your disclosure beginning on page 114, as appropriate. The Company advises the Staff that, following the consummation of the offering, it will not be a “controlled company” under Nasdaq Listing Rule 5615(c), as no individual, group or other company will hold more than 50% of the voting power for the election of the Company’s directors. The officers, directors and significant stockholders referred to on pages 53 and 133 of the Registration Statement would not collectively be considered a “group” for purposes of Nasdaq Listing Rule 5615(c), and no single individual or “group” of Company stockholders has greater than 50% of the voting power for the election of the Company’s directors. Use of Proceeds, page 56 8. Please revise to clarify what you mean by “commercialization” of your product. If that term includes multiple, discrete uses to which you will apply proceeds, such as expanding your domestic sales force and manufacturing facilities, as noted on page 71, please describe those uses separately. Also describe whether the amount of proceeds will be sufficient or whether you will require additional funds. In response to the Staff’s comment, the Company has revised its disclosure on page 57 of the Registration Statement. Dilution, page 60 9. Please expand the disclosure on page 61 to clarify how the numbers and percentages in the table on that page would change assuming the exercise of all outstanding warrants and options. In response to the Staff’s comment, the Company has revised its disclosure on page 64 of the Registration Statement. U.S. Securities and Exchange Commission September 9, 2016 Page 5 Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 66 Overview, page 66 10. Please revise to clarify why it was necessary to discontinue sales in Europe and Mexico to focus on developing and seeking domestic regulatory approval of your current product. In response to the Staff’s comment, the Company has revised its disclosure on page 68 of the Registration Statement. Results of Operations, page 69 11. Please revise your discussion of revenues throughout this section to discuss, and where possible quantify, the changes in your revenues resulting from changes in prices, changes in volume or a combination of both items. Please refer to Item 303 and the related instructions in Regulations S-K as well as SEC Interpretive Release No. 33-8350. The Company advises the Staff that fluctuations in revenue were nearly entirely a result of changes in the volume of its product sold. The Company has revised its disclosure on pages 71 and 72 of the Registration Statement to clarify this fact. Liquidity and Capital Resources, page 70 12. We note from disclosures on page F-10 that a significant portion of your revenue is derived from foreign sources. We also note on pages F-3 and F-27 that your balance sheet presents cash and cash equivalents of approximately $3.3 million and $4.3 million as of December 31, 2015 and June 30, 2016, respectively. Please revise your liquidity discussion in Management’s Discussion and Analysis in future filings, to the extent that you believe material, to disclose the amount of cash and cash equivalents as well as liquid investments held by foreign subsidiaries at each balance sheet date presented in your financial statements and quantify the amount that would not be available for use in the United States without incurring U.S taxes. Please further provide a discussion of any known trends, demands or uncertainties as a result of your policies of permanently reinvesting earnings outside the United States that are reasonably likely to have a material effect on the business as a whole or that may be relevant to your financial flexibility. Refer to Item 303(a)(1) of Regulation S-K. The Company respectfully advises the Staff that, to date, the Company has only sold its product outside of the United States. The Company’s sales have been primarily to its sole distributor in the Middle East, Bader Sultan & Bros. Co W.L.L. (“Bader”), and the Company has historically sold its product in Europe and Mexico as well. All sales to Bader and into Europe have been made, and the cash received from such sales has been held, by the Company, which is located in the United States. The only other entity with sales and the ability to generate cash was the Company’s Mexico subsidiary, which always generated losses and had negative cash flows. U.S. Securities and Exchange Commission September 9, 2016 Page 6 As of December 31, 2015, the Company had approximately $7,000 in cash held by two foreign subsidiaries. As of June 30, 2016, both of the Company’s foreign subsidiaries had been dissolved. As further described in the Company’s response to comment 29 below, both of the foreign subsidiaries were never profitable and had cumulative net losses and, accordingly, all of the cash previously held by the foreign subsidiaries would have been available for use in the United States without incurring U.S. taxes. The Company does not believe that the insignificant amount held by the foreign subsidiaries in the past has had or will have a material effect on its business. 13. Given the historical amounts of cash you have used for the periods disclosed in your financial statements and amounts in the table on page 74, please revise to clarify why you believe the $18.3 million of cash, cash equivalents and short-term investments you hold as of June 30, 2016 will not be sufficient for the next 12 months, absent the proceeds of this offering. The Company advises that Staff that it has recently received approval of its Obalon balloon system from the FDA, and therefore expects to incur substantial additional expenditures in the next 12 months in connection with the commercial launch of its product in the United States, including the development of a direct sales force and the expansion of its manufacturing facilities. In response to the Staff’s comment, the Company has revised its disclosure on pages 72 and 73 of the Registration Statement to clarify that, absent the proceeds from the initial public offering, it would likely be unable to completely fund its planned expenditures in the next 12 months, particularly those related to the commercial launch of its product. Contractual Obligations, page 74 14. Please revise to quantify the amounts subject to the contracts noted in the first full paragraph following the table. The Company advises the Staff that any future amounts that may become owed to the Company’s clinical trial sites, clinical supply manufacturing organizations or vendors for preclinical studies, research supplies and other services are contingent upon an underlying event occurring, such as patient visits, internal Company approval of additional preclinical studies and further research, and are not legally binding or enforceable contractual purchase obligations unde
2016-08-31 - UPLOAD - Vyome Holdings, Inc
Mail Stop 3030 August 31, 2016 Via E -mail Andrew Rasdal President and Chief Executive Officer Obalon Therapeutics, Inc. 5421 Avenida Encinas, Suite F Carlsbad, CA 92008 Re: Obalon Therapeutics, Inc. Draft Registration Statement on Form S -1 Submitted August 4, 2016 CIK No. 0001427570 Dear Mr. Rasdal : 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 response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Prospectus Summary, page 1 The Obesity Epidemic, page 1 1. Please revise to clarify what you mean by “medical costs associated with obesity.” If this phrase includes costs related to the effects of obesity, rather than merely related to the treatment for obesity, please revise to clarify. Also revise to clarify what portion of that amount relates to the treatment of obesity. Andrew Rasdal Obalon Therapeutics, Inc. August 31, 2016 Page 2 Our Solution, page 2 Favorable Safety Profile, page 2 2. Please reconcile your disclosure here that all the reported serious adverse device events from your product occurred when the product was not used according to approved labelling with your disclosure in the first full paragraph on page 16 which indicates that in one instance you could not obt ain enough information to verify an injury’s cause. Simple and Convenient Placement, page 2 3. If you believe it is appropriate to highlight the fact that your product can be placed without anesthesia or an endoscopy, please also provide disclosure, such as that found on page 4, indicating that removal of your product does require an endoscopy and sedation. Implications of Being an Emerging Growth Company, page 6 4. 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. Summary Consolidated Fi nancial Data, page 9 5. We note on page 10 and throughout the filing that you have presented pro forma adjustments relating to the automatic conversion of all the outstanding shares of your convertible preferred stock into common stock and ultimately the automatic conversion of your outstanding preferred warrants to purchase common stock. We further note from pages F -43 and F -44 that all of the preferred stock is automatically converted into common stock upon the company’s sale of your common stock in a firm commitment underwritt en public offering in which the per share is price is at least $4.29. Explain to us why you believe these pro forma adjustments related to the conversion of your preferred shares upon the initial public offering are factually supportable by confirming to us that you presently expect the offering to meet such conditions. If management subsequently concludes the conditions may not be satisfied, please revise the filing accordingly. 6. Explain to us why you believe that the outstanding preferred stock warra nts and other warrants will be ultimately converted into common stock upon the initial public offering and are directly attributable to the transaction and factually supportable. Andrew Rasdal Obalon Therapeutics, Inc. August 31, 2016 Page 3 Risk Factors, page 11 7. Given your disclosure on pages 52 and 130, please re vise to clarify whether you will be a controlled company under applicable exchange rules and, if so, whether that status creates material risks. Also revise your disclosure beginning on page 114, as appropriate. Use of Proceeds, page 56 8. Please revise to clarify what you mean by “commercialization” of your product. If that term includes multiple, discrete uses to which you will apply proceeds, such as expanding your domestic sales force and manufacturing facilities, as noted on page 71, please describe those uses separately. Also describe whether the amount of proceeds will be sufficient or whether you will require additional funds. Dilution, page 60 9. Please expand the disclosure on page 61 to clarify how the numbers and percentages in the table on th at page would change assuming the exercise of all outstanding warrants and options. Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 66 Overview, page 66 10. Please revise to clarify why it was necessary to disco ntinue sales in Europe and Mexico to focus on developing and seeking domestic regulatory approval of your current product. Results of Operations, page 69 11. Please revise your discussion of revenues throughout this section to discuss, and where possible quantify, the changes in your revenues resulting from changes in prices, changes in volume or a combination of both items. Please refer to Item 303 and the related instructions in Regulations S -K as well as SEC Interpretive Release No. 33 -8350. Liquidity and Capital Resources, page 70 12. We note from disclosures on page F -10 that a significant portion of your revenue is derived from foreign sources. We also note on pages F -3 and F -27 that your balance sheet presents cash and cash equivalents of approximate ly $3.3 million and $4.3 million as of December 31, 2015 and June 30, 2016, respectively. Please revise your liquidity discussion in Management’s Discussion and Analysis in future filings, to the extent that Andrew Rasdal Obalon Therapeutics, Inc. August 31, 2016 Page 4 you believe material, to disclose the amount of cash and cash equivalents as well as liquid investments held by foreign subsidiaries at each balance sheet date presented in your financial statements and quantify the amount that would not be available for use in the United States without incurring U.S t axes. Please further provide a discussion of any known trends, demands or uncertainties as a result of your policies of permanently reinvesting earnings outside the United States that are reasonably likely to have a material effect on the business as a wh ole or that may be relevant to your financial flexibility. Refer to Item 303(a)(1) of Regulation S -K. 13. Given the historical amounts of cash you have used for the periods disclosed in your financial statements and amounts in the table on page 74, please re vise to clarify why you believe the $18.3 million of cash, cash equivalents and short -term investments you hold as of June 30, 2016 will not be sufficient for the next 12 months, absent the proceeds of this offering. Contractual Obligations, page 74 14. Please revise to quantify the amounts subject to the contracts noted in the first full paragraph following the table. Critical Accounting Policies and Estimates, page 74 Stock -Based Compensation, page 75 15. We note on page F -42 that you granted 1,482,662 o ptions to purchase common stock during the six months ended June 30, 2016. With respect to these options granted, please provide us with your analysis in valuing those grants including a detailed analysis on how you determined the underlying fair value of your common stock. 16. We note that for determining the expected volatility you relied on the volatility of a peer group that are publicly traded. Please provide to us the names of the companies you considered peer companies for purposes of determining the v olatility assumption, the volatility of each, and how you concluded that each company was similar to you. Tell us whether you considered industry, stage of life cycle, size, and financial leverage. Refer to FASB ASC 718 -10-55-25. Andrew Rasdal Obalon Therapeutics, Inc. August 31, 2016 Page 5 17. We note that you disclo sed a placeholder for the aggregate intrinsic value of all outstanding options based on the midpoint of the estimated IPO price range. Please include an updated discussion of each significant factor contributing to the difference between the fair value as of the date of grant and the estimated IPO price for options granted during the six months prior to the date of the most recent balance sheet once you have determined your IPO price range. Business, page 81 Overview, page 81 18. Given your disclosure on page 95 regarding saline -filled balloons previously approved by the FDA and your disclosure on page 98 regarding the requirements for approval of Class II devices, please revise to clarify why you are seeking approval pursuant to t he “PMA process.” Recently developed treatment alternatives, page 84 19. We note the data from your competitors’ clinical trials. Please expand to disclose the data relating to the amount of pounds lost during and as of the completion of those trials, simil ar to the information you disclose on pages 91 and 92 regarding your clinical trial. Our solution, page 85 20. Your disclosure here and on page 93 implies that the sustainability of weight loss relates to the use of your product. You r disclosure on page 8 4 implies that use of your competitors’ products relates to lower sustained weight loss than if your product w ere used. If so, please revise to clarify the basis for this conclusion. Please address in your response your consideration of other factors und erlying the ability to sustain weight loss following use of your product relative to your competitors, such as the individual behaviors of the participants in the studies, as opposed to the characteristics of the products . Please also clarify whether simi lar six -month follow -up was performed for the sham -control group. Sales and Marketing, page 94 21. Please expand to discuss the material features of your distribution agreement with Bader, including the minimum purchase requirements and other terms mention ed on pages 20 and 21. Andrew Rasdal Obalon Therapeutics, Inc. August 31, 2016 Page 6 Competition, page 94 22. Please revise to clarify the nature of the intragastric balloon developed by Allurion Technologies, as noted on page 95. Intellectual Property, page 96 23. Please revise to clarify the claims covered by the i ntellectual property described on this page. Ensure you r revisions address the “proprietary” features of the gas mix used to inflate balloons and how those features are protected. Principal Stockholders, page 129 24. Please disclose all natural persons who exercise the sole or shared voting and/or dispositive powers with respect to the shares held in the name of the entities identified in the table on page 130. Also, please tell us why you do not include your Chief Fi nancial Officer. Shares eligible for future sale, page 138 25. Please clarify the reference to “substantially all” security holders who entered into the lock-up agreements. Please also file those agreements as exhibits. Consolidated Financial Statement s Note 2. Summary of Significant Accounting Policies Revenue Recognition, page F -12 26. We note that you sell your products to distributors including your related party distributor arrangement with Bader Sultan & Bros. Co W.L.L. Please revise your disclos ure to summarize the significant terms of these arrangements with distributors, including any post shipment obligations and acceptance provisions that may exist and how you account for such obligations. Within your discussion, please explain if you grant price concessions to your distributors and, if so, how you account for price concessions. Refer to SAB Topic 13.B. 27. We further note that you recognized revenue net of allowances, discounts, and other adjustments. Please tell us and revise your filing to explain the nature of the allowances, discounts, and other adjustments for which you adjust revenue. Explain how you account for these allowances, discounts, and other adjustments. Andrew Rasdal Obalon Therapeutics, Inc. August 31, 2016 Page 7 Note 3. Fair Value Measurements, page F -15 28. Please revise your filing to explain how you determined the underlying significant assumptions within the Black -Scholes option pricing model to determine the fair value of your outstanding warrant liability. Refer to ASC 718 -10-50-2(f)(2). Note 9. Income Taxes, page F -25 29. We note from disclosures on page F -25 that you do not provide U.S. taxes and foreign withholding taxes on the undistributed earnings of foreign subsidiaries because you intend to permanently reinvest such earnings outside the U.S. Please revise your filing to disclose the amount of undistributed earnings related to your foreign subsidiaries that you consider to be indefinitely reinvested. Refer to the guidance in FASB ASC 740 -30-50- 2(b). You may contact Tara Harkins at (202) 551 -3639 or Kate Tillan, Assistant Chief Accountant, at (202) 551 -3604 if you have questions regarding comments on the financial statements and related matters. Please contact Caleb French at (202) 551 -6947 or Geoff Kruczek, Senior Attorney, at (202) 551 -3641 with any other questions. Sincerely, /s/ Geoff Kruczek for Amanda Ravitz Assistant Director Office of Electronics and Machinery cc: Robert A. Freedman, Esq. Fenwick & West LLP