SEC Comment Letter 0000000000-24-014140 to Vyome Holdings, Inc (HIND)
Vyome Holdings, Inc
Date: Dec. 20, 2024 · CIK: 0001427570 · Accession: 0000000000-24-014140
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File numbers found in text: 333-282459
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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.