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Correspondence 0001104659-24-125984 from Vyome Holdings, Inc (HIND)

Vyome Holdings, Inc
Date: Dec. 5, 2024 · CIK: 0001427570 · Accession: 0001104659-24-125984

AI Filing Summary & Sentiment

File numbers found in text: 333-282459

Date
December 5, 2024
Author
Not clearly detected
Form
CORRESP
Company
Vyome Holdings, Inc

Letter

Re: ReShape Lifesciences Inc.

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

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

Show Raw Text
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