# EDGAR Filing Document

**Accession Number:** 0001427570
**File Stem:** 0001213900-26-008575
**Filing Date:** 2026-1
**Character Count:** 48923
**Document Hash:** 72210b3c2ac9bda390920940644fce2c
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-26-008575.hdr.sgml**: 20260128

**ACCESSION NUMBER**: 0001213900-26-008575

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 40

**CONFORMED PERIOD OF REPORT**: 20260128

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260128

**DATE AS OF CHANGE**: 20260128

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Vyome Holdings, Inc
- **CENTRAL INDEX KEY:** 0001427570
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37897
- **FILM NUMBER:** 26568664

**BUSINESS ADDRESS:**
- **STREET 1:** 1001 CALLE AMANECER
- **CITY:** SAN CLEMENTE
- **STATE:** CA
- **ZIP:** 92673
- **BUSINESS PHONE:** 949-429-6680

**MAIL ADDRESS:**
- **STREET 1:** 1001 CALLE AMANECER
- **CITY:** SAN CLEMENTE
- **STATE:** CA
- **ZIP:** 92673

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ReShape Lifesciences Inc.
- **DATE OF NAME CHANGE:** 20210621

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** OBALON THERAPEUTICS INC
- **DATE OF NAME CHANGE:** 20080220

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

Date of Report (Date of earliest event reported): **January 28, 2026**

**VYOME HOLDINGS, INC.**

(Exact name of registrant as specified in its charter)

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|:---|:---|:---|
| &nbsp;&nbsp;**Delaware** | &nbsp;&nbsp;**1-37897** | &nbsp;&nbsp;**26-1828101** |
| &nbsp;&nbsp;(State or other jurisdiction of<br> incorporation) | &nbsp;&nbsp;(Commission File Number) | &nbsp;&nbsp;(I.R.S. Employer<br> Identification Number) |

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| | |
|:---|:---|
| &nbsp;&nbsp; **Harvard Square, One Mifflin Place, Suite 400**<br> **Cambridge, MA** | &nbsp;&nbsp; <br> **02138** |
| &nbsp;&nbsp;(Address of principal executive offices) | &nbsp;&nbsp;(Zip Code) |

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**(949) 429-6680**

(Registrant's telephone number, including area code)

**Not applicable**

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities** **registered pursuant to Section 12(b) of the Act:**

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| | |
|:---|:---|
| **Title of Class** | **Name of Exchange on which Registered** |
| Common stock, $0.001 par value per share HIND | The Nasdaq Capital Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 7.01 Regulation FD Disclosure.**

Representatives of Vyome Holdings, Inc. (the "Company") intend to make presentations at investor conferences and in other forums, and these presentations may include the information contained in Exhibit 99.1 attached to this Current Report on Form 8-K. A copy of the presentation materials containing such information that may be disclosed by the Company is attached as Exhibit 99.1 to this report, and the information set forth therein is incorporated herein by reference and constitutes a part of this report.

The Company is furnishing the information contained in Exhibit 99.1 pursuant to Regulation FD and Item 7.01 of Form 8-K promulgated by the Securities and Exchange Commission ("SEC"). This information shall not be deemed to be "filed" with the SEC for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

The information contained in Exhibit 99.1 is summary information that is intended to be considered in the context of the Company's SEC filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in Exhibit 99.1, although it may do so from time to time as its management believes is warranted. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure. By filing this report and furnishing this information, the Company makes no admission as to the materiality of any information contained in this report, including Exhibit 99.1.

**Forward-Looking Statements**

Certain statements made in this filing are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "target," "believe," "expect," "will," "shall," "may," "anticipate," "estimate," "would," "positioned," "future," "forecast," "intend," "plan," "project," "outlook", and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such statements, include, but are not limited to, statements contained in this press release relating to the Company's business strategy, the Company's future operating results and liquidity and capital resources outlook, the successful Phase 3 completion and anticipated expenses relating to the same, the total addressable pharmacologic market in the United States for malignant fungating wounds, and the estimated peak annual net sales for VT-1953. Forward-looking statements are based on the Company's current expectations and assumptions regarding the Company's business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. The Company's actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. The Company cautions you, therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, the Company's ability to raise capital to fund continuing operations; our ability to protect the Company's intellectual property rights; the impact of any infringement actions or other litigation brought against the Company; competition from other providers and products; the Company's ability to develop and commercialize products and services, including VT-1953; changes in government regulation; the Company's ability to complete capital raising transactions; and other factors relating to the Company's industry, operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Factors or events that could cause the Company's actual results to differ may emerge from time to time, and it is not possible for the Company to predict all of them. the Company cannot guarantee future results, levels of activity, performance, or achievements. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release, except as may be required under applicable securities law.

**Item 8.01 Other Events.**

On January 27, 2026, the Company issued a press release announcing key findings from an independent U.S. market assessment, commercial forecast, and valuation analysis of VT-1953, the Company's lead clinical candidate for the treatment of symptoms of malignant fungating wounds (MFW). A copy of the press release is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K, and the information set forth therein is incorporated herein by reference and constitutes a part of this report.

**Item 9.01 Financial Statements and Exhibits.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Product Assessment and Valuation Report (furnished herewith)](ea027436701ex99-1_vyome.htm) |
| 99.2 | [Press Release issued January 27, 2026](ea027436701ex99-2_vyome.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | |
|:---|:---|
| **RESHAPE LIFESCIENCES INC.** | **RESHAPE LIFESCIENCES INC.** |
| By: | */s/ Venkat Nelabhotla* |
|  | Venkat Nelabhotla |
|  | President & Chief Executive Officer |

---

Dated: January 28, 2026

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

1 U.S. Market & Product Assessment and Valuation of VT - 1953 for the Treatment of Symptoms of Malignant Fungating Wounds H1 2026

![](ex99-1_002.jpg)

2 PROJECT OVERVIEW Destum Partners performed a U.S. market and product assessment, commercial forecast, and valuation for the use of VT - 1953 for the treatment of symptoms of Malignant Fungating Wounds (MFW) Commercial Forecast Market & Product Assessment ▪ Epidemiology ▪ Market Dynamics ▪ Target Product Profile ▪ Pricing & Reimbursement ▪ Competitive Landscape ▪ Development Strategy ▪ Strategic Positioning ▪ Relevant Development Expenses Valuation ▪ rNPV valuation ▪ Sensitivity and scenario analyses ▪ Model asset value change overtime, IRR, ROI, payback period & other financial metrics ▪ Patient - derived commercial forecast (units and revenue) ▪ Base scenario and sensitivity analyses ▪ Evaluation of overall business case

![](ex99-1_003.jpg)

3 Summary Unmet Need • Malignant fungating wounds (MFWs) are a rare but devastating complication of advanced solid tumors, occurring predominantly in the final 6 - 12 months of life and associated with severe malodor, pain, exudate, bleeding, and psychosocial distress • Management is palliative and symptom - focused; no therapies address underlying inflammatory and microbial drivers of MFW symptoms, and wounds rarely heal • Patients and caregivers face high burden of care, frequent dressing changes, and social isolation, underscoring a significant unmet need in oncology wound care Market Landscape and Dynamics • There are no FDA - approved therapies indicated for the symptoms of malignant fungating wounds • Current management relies on fragmented, off - label interventions, each address individual symptoms with variable and incomplete effectiveness with difficulty to administer by clinicians, patients, and caregivers • Review of development pipelines did not identify any approved or late - stage investigational therapies targeting MFW symptoms VT - 1953 Market Positioning • VT - 1953 has the potential to be a first - in - class, indication - specific therapy for MFW symptom management • By targeting key inflammatory and microbial contributors to malodor and pain, VT - 1953 is designed to address multiple core symptoms with a single topical therapy • VT - 1953 is expected to complement and replace much of the off - label approaches to MFW symptom treatment • Pricing and access considerations are expected to meaningfully influence uptake, with KOLs highlighting the importance of affordability for their patients Program Value • Despite a relatively small patient population, the absence of direct therapeutic competition and high unmet need support meaningful clinical and commercial value • The base - case valuation of VT - 1953 by rNPV methodology is $455M in the United States as of as of Phase 2 completion and will grow to $1.086B H1 2028 following completion of the Phase 3 study • Based on Destum's bottom - up model, incorporating modeled patient counts, treatment duration, and pricing assumptions, and a 30% peak market share, VT - 1953's modeled peak sales imply a total addressable pharmacologic MFW symptom - treatment market of approximately $2.2B in 2026 and growing to $2.8B in 2040 in the United States • An optimal partner for VT - 1953 would have capabilities in oncology supportive or wound care, access to oncology, palliative, and hospice settings, and the ability to enable efficient market access and adoption for a novel therapy in this space (i.e., BMS, Pierre Fabre, Servier, Almirall, Helsinn, Horizon (Amgen), and Recordati Rare Disease to name a few) • Despite significant research, limited comparable transactions with publicly disclosed terms were identified

![](ex99-1_004.jpg)

4 $455 $503 $551 $602 $1,086 $1,165 $1,346 $1,420 $1,499 $1,605 $1,674 $1,700 $1,727 $400 $200 $0 $600 $1,000 $800 $1,200 $1,400 600 $1, $1,800 $2,000 H1 2026 H2 2026 H1 2027 H2 2027 H1 2028 H2 2028 H1 2029 H2 2029 Phase 3 Completion Commercial Approval H1 2030 H2 2030 H1 2031 H2 2031 H1 2032 Asset Value ($mm) VT - 1953 – Value Over Time VT - 1953 currently has a value of $455M in the United States growing to over $1B in 2028 following completion of the Phase 3 trial Near - Term Value Inflection Points The initial NPV of VT - 1953 is estimated at $455M in the United States in H1 2026 with value inflection points in H1 2028 following completion of the Phase 3 trial, and in H1 2029 upon receiving commercial approval.

![](ex99-1_005.jpg)

5 **Table of Contents** VT - 1953 for the Treatment of Symptoms of Malignant Fungating Wounds ▪ Background & Epidemiology ▪ Treatment Algorithm ▪ Competitive Landscape ▪ Total Treatable Patient Population ▪ Market Size & Potential ▪ Risk Assessments ▪ Forecast ▪ rNPV ▪ Summary

![](ex99-1_006.jpg)

6 Malignant Fungating Wounds Overview Malignant fungating wounds are cutaneous manifestations of locally advanced cancer caused by tumor invasion, ischemia, necrosis, and polymicrobial colonization that sustain chronic inflammation and prevent healing ▪ Malignant fungating wounds occur when cells infiltrate the dermis and subcutaneous tissue, disrupting normal vascular and lymphatic structures and causing tissue ischemia and necrosis. 1 ▪ These wounds represent a cutaneous manifestation of locally advanced malignancy and are most frequently associated with breast, head and neck, and genitourinary cancers, although any tumor extending to the skin can produce them. 2 ▪ The resulting necrotic and hypoxic tissue forms a nutrient - rich microenvironment that supports dense polymicrobial colonization exceeding 10 5 CFU per gram, typically involving Staphylococcus aureus , Pseudomonas aeruginosa , Bacteroides , and Peptostreptococcus species. 3 ▪ Anaerobic metabolism by these organisms generates volatile amines such as putrescine and cadaverine that cause the characteristic malodor, while tumor - and host - derived cytokines (IL - 1β, IL - 6, TNF - α) sustain inflammation and nociceptor activation, leading to pain and exudate production. 3 ▪ Clinically, MFW appear as ulcerative or exophytic lesions with friable, necrotic tissue, heavy drainage, intermittent bleeding, and severe odor that collectively result in profound psychosocial distress and impaired quality of life . 2 , 3 1. Vardhan et al., Front Cell Infect Microbiol. 2019. 2. NCCN Palliative Care Guidelines, V2. 2025 3. Tilley et al. J Wound Ostomy Continence Nurs. 2021. 4. Morris, British J Nurs, 2008. Diagram Representing Malignant Fungating Wound 4

![](ex99-1_007.jpg)

7 Malignant Fungating Wounds Epidemiology MFWs are an uncommon complication of advanced solid tumors concentrated near end of life ▪ MFWs occur almost exclusively in patients with advanced or uncontrolled solid tumors, most commonly breast cancer (~50 - 70%) and head & neck cancers, with smaller contributions from gynecologic, genitourinary, and other solid tumors. 1 ▪ Data on the incidence of MFWs is limited, though most authors agree that between 5 - 14% of advanced or terminal cancer patients will develop a MFW. 1 ▪ MFWs typically develop late in the disease course, most often during the final 6 - 12 months of life, and are considered a marker of terminal or near - terminal cancer. After reviewing 77 cases of cutaneous tumor metastases over 10 years, Saeed et al, reported that 28.6% of patients died within the first month following diagnosis, 66.23% had died within the first six months, and 75% within the first 12 months. 2 ▪ No reliable epidemiologic data quantifying the annual prevalence of advanced or terminal cancer patients with MFWs is available. Given the strong end - of - life clustering, Destum used annual U.S. cancer mortality as a proxy for the advanced cancer population at risk. The American cancer society estimates the number of cancer deaths in the U.S. continued to fall in 2025 to 618,120. 3 ▪ U.S. cancer incidence and mortality are projected to decline though 2040, reflecting earlier detection and improved therapeutics. From data published by Rahib et al, Destum calculated an annual rate of decrease of 1.5%. 4 ▪ For modeling purposes, Destum used the midpoint of published incidence estimates (9.5%) for the proportion of advanced or terminal cancer patients who develop an MFW. Applying this rate to ACS reported U.S. cancer mortality in 2025, yields an estimated 58,721 MFW cases in the United States in 2025. 1. Tilley et al. J Wound Ostomy Continence Nurs. 2021. 2. Alexander S, J Wound Care. 2009. 3. Siegel et al. CA Cancer J Clin. 2025. 4. Rahib et al. Oncology. 2021.

![](ex99-1_008.jpg)

8 Symptom Management Care for MFWs is palliative and symptom - focused, relying on off - label therapies and advanced wound care rather than disease modification ▪ Management of MFWs is not directed at treating the underlying malignancy, but instead focuses on palliative treatment of local symptoms, including odor, pain, exudate, bleeding, ▪ Infection: MFWs are typically colonized rather than acutely infected. Systemic antibiotics are generally avoided unless there are signs of invasive infection, as penetration into necrotic tissue is poor and benefits are limited. 1. NCCN Palliative Care Guidelines, V2. 2025 2. Furka et al. Cancers. 2022. and infections. 1 ▪ There are currently no FDA - approved therapies specifically for the symptoms of malignant fungating wounds . Current management is fragmented, off - label, and symptom - specific, often requiring multiple concurrent interventions with variable effectiveness and high burden of care. Key Symptoms & Management Approaches 1 ▪ Malodor : Odor is primarily driven by bacterial metabolism within necrotic tissues . Standard management includes topical antimicrobials, most commonly off - label metronidazole, along with charcoal or silver - impregnated dressings to absorb odor - causing compounds . ▪ Pain: Pain arises from inflammation, tissues ischemia, and nerve involvement. Management typically combines systemic analgesics, including opioids, with topical anesthetics or analgesic adjuncts. ▪ Exudate: Heavy exudate is managed with high - absorbency dressings and frequent dressing changes; in severe cases, drainage systems may be required. ▪ Bleeding : Friable tumor vasculature can cause recurrent bleeding . Local measures include non - adherent dressings, topical hemostatic agents, and gentle wound handling . Multidisciplinary View of Cancerous Wounds Treatment 2

![](ex99-1_009.jpg)

9 **Table of Contents** VT - 1953 for the Treatment of Symptoms of Malignant Fungating Wounds ▪ Background & Epidemiology ▪ Treatment Algorithm ▪ Competitive Landscape ▪ Total Treatable Patient Population ▪ Market Size & Potential ▪ Risk Assessments ▪ Forecast ▪ rNPV ▪ Summary

![](ex99-1_010.jpg)

10 Competitive Landscape for VT - 1953 1. Destum Analysis No approved or late - stage therapies are in development for the symptoms of malignant fungating wounds • There are currently no FDA - approved drugs or late - stage clinical programs specifically indicated for malignant fungating wounds, positioning VT - 1953 as a potential first - in - class, indication - specific therapy • The current treatment landscape consists primarily of repurposed or off - label products used to manage individual symptoms rather than underlying inflammatory or microbial drivers of MFW symptoms • Review of current development pipelines did not identify any investigational therapies targeting MFW symptoms other than VT - 1953. • Primary market research and KOL interviews conducted by Destum Partners confirm that off - label metronidazole is widely used and is expected to remain part of standard of care, but is viewed as insufficient as a standalone solution due to limited symptom coverage and lack of approval • As a result, VT - 1953 is expected to enter a market with minimal direct therapeutic competition, with adoption driven by its ability to complement or replace fragmented off - label approaches

![](ex99-1_011.jpg)

11 Market Share Estimation 1. Destum Analysis VT - 1953 enters a market where providers and patients are actively seeking new treatment options given the limited options currently available No current FDA approved topical treatments for malignant fungating wounds • Currently, there are no FDA approved topical treatments available to patients for malignant fungating wounds • As supported by Destum Partner's primary market research, key opinion leaders (KOLs) state the need for new treatment options in this space for their patients No current viable competitors in development for malignant fungating wounds • Currently, there are no viable competitors in development for malignant fungating wounds leaving the door of opportunity open for VT - 1953 to become a competitive treatment option for patients in the space Effective topical treatments available in preferred formulations • Despite there being no current FDA approved topical treatments for patients with malignant fungating wounds and no viable competitors in development, KOLs emphasize the effectiveness of off label used products such a metronidazole for the treatment of malignant fungating wound symptoms. Nonetheless, significant administration burden of metronidazole (crushed oral tablets) exists for clinicians, patients, and caregivers Socioeconomic factors driving market share • As supported by Destum Partner's research, majority of patients experiencing malignant fungating wounds fall into the Medicare / Medicaid insurance bucket and need affordable and accessible treatment options for their disease. Given the affordability and accessibility of comparable products such as StrataXRL®, Destum Partners assumed a 30% peak market share for VT - 1953

![](ex99-1_012.jpg)

12 Benchmarking VT - 1953 Pricing Destum evaluated relevant products in orphan dermatology, wound care, and palliative symptom relief to inform a clinically and commercially grounded Wholesale Acquisition Cost (WAC) for VT - 1953 To establish a realistic and defensible WAC for VT - 1953, Destum evaluated a range of comparable products and market dynamics • Mechanism and Intended Use: VT - 1953 is a topical therapy for symptom relief rather than wound healing or disease modification. This differentiates it from high - cost regenerative agents like Regranex® and Filsuvez®. • Most Relevant Comparables : Products like Rectiv®, Amzeeq®, and Eucrisa® share similar characteristics, including route, intended use, and chronic or sensitive populations. These products cluster in the $13 - $22/gram range. • Context of Use and Access Considerations: In late - stage cancer care, affordability and payer support are critical. Prescribers interviewed emphasized that patient access is often dictated by coverage. Taking these into account along with KOL's responses, Destum proposes a WAC of $20/gram , or $9,125 per month assuming 7.5 g per application twice per day, for VT - 1953, reflecting VT - 1953's clinical role and aligning with comparable pricing. 1. BIO. Clinical Development Success Rates and Contributing Factors 2011 - 2020. Price/Gram WAC Price Route Indication Product $80 $1,872 (23.4 g) Topical gel Epidermolysis Bullosa Filsuvez® (birch triterpenes) - - $24,250/vial Topical gene Epidermolysis Bullosa Vyjuvek® (beremagene geperpavec) $86.33 $1,295 (15g) Topical gel Ulcer wounds Regranex® (becaplermin) Kit - priced $585 - 3,634 Topical patch Neuropathic pain Qutenza® (capsaicin 8%) $21.36 $640.74 (30g) Rectal ointment Anal fissure pain Rectiv® (nitroglycerin 0.4% $9.14 $274.25 Topical ointment Burns, ulcers Santyl® (collagenase) $16.81 $503.40 Topical foam Acne Amzeeq® (minocycline) $13.22 $793.41 (60g) Topical ointment Atopic Dermatitis Eucrisa® (crisaborole)

![](ex99-1_013.jpg)

13 Clinical Development Plan Destum used the following clinical development timeline for its valuation of VT - 1953 2030 2029 2028 2027 2026 2025 Commercial FDA Review Phase 3 $12.5 M VT - 1953 Malignant Fungating Wounds Clinical Development Plan & Timelines: Phase 3 trial start: Q3 2026 Phase 3 trial completion: Q4 2027 NDA approval: Q4 2028 Product launch: Q4 2028 H2 2026: Add misc. prep/consulting $500K Development and Regulatory Costs: Phase 3 costs include cost of trial, CMC cost, and related G&A costs of the public company. Estimated costs from now until 2028, including allocated salaries and overheads, are $10 million. PDUFA waived under orphan drug designation

![](ex99-1_014.jpg)

14 U.S. Patient Population for VT - 1953 for Treatment of Symptoms of MFW Estimated U.S. New Cases in 2025 of Cancer at any Site 2,041,910 Estimated Number of Patients with MFWs 58,721 U.S. Treatable Patient Population 58,721 ▪ The American Cancer Society estimates there will be approximately 2,041,910 new cancer cases in the United States in 2025. 1 Estimated Number of Cancer Related Deaths 618,120 1. Siegel et al. Cancer Statistics, 2025. CA Cancer Journal for Clinicians. 2025. 2. Rahib et al. JAMA Netw Open 2021. 3. Vardhan et al., 2019 ▪ Vardhan et al., 2019 reported that approximately 5 - 14% of patients with advanced cancer in the United States develop MFWs. 3 Destum applied the midpoint (9.5%) of this range to the 2025 U.S. cancer mortality estimate to approximate annual MFW onset. ▪ MFWs occur almost exclusively in advanced or terminal cancer; Destum used U.S. cancer mortality as a proxy for the annual population of advanced cancer patients. American Cancer Society estimates 618,120 cancer deaths in 2025 1 ▪ Because updated U.S. mortality projections are not yet available, Destum estimated forward - year values by applying the mortality growth rate reported by Rahib et al., 2021 to the ACS 2025 baseline, pairing the most current baseline figure with peer - reviewed trend data. 2 ▪ Based on the above stratifiers, Destum estimates ~58k U.S. patients with malignant fungating wounds in 2025, representing the treatable population for VT - 1953 in the United States

![](ex99-1_015.jpg)

15 Commercial Assumptions Destum Partners made the following commercial assumptions for its valuation Rationale Assumption Expense Industry Standard 5% WAC\* COGs\* Average of Major Pharma 28% of sales SG&A and Marketing Credit Suisse 2 20% of sales Gross - to - Net Calculation (Rebates, etc.) Industry Standard 1 2% of sales Distribution Expense Industry Standard 1 1% of sales Legal & Consulting Expense Industry Standard 1 1% of sales Pharmacovigilance Patent Expiration Date 2043 Patent Expiration US Corporate Tax Rate 21% Tax Rate Industry Standard 15% Discount Rate 1. Based on Destum's transaction experience; 36 transactions since 2015 totaling $5.05B+ in Deal Value 2. Credit Suisse: Global Pharma, Equity Research Report 2015 Canva.com

![](ex99-1_016.jpg)

16 Probability of Success Destum estimates that VT - 1953 has a 56.5% probability of approval based on historical rates of success for non - oncology rare diseases. Cumulative Likelihood Of Approval from Event Approval Predicted Probability of Success Event 56.5%\* 60.4% Successful Phase III 93.6% 93.6% Approval 1. BIO. Clinical Development Success Rates and Contributing Factors 2011 - 2020. \*Calculated as the product of Phase III to Approval (60.4%) and NDA to Approval (93.6%) success rates for non - oncology rare diseases

![](ex99-1_017.jpg)

17 Revenue Forecast Assumptions Rationale Destum Partners' Assumption • Commercial launch modeled in H1 2029 with forecast extending through expected patent expiration to capture full commercial window ▪ H1 2026 – H2 2043 Forecast Period • Based on 20 - year patent term with filing date of 2023 ▪ 2043 IP/Exclusivity • Total Cancer Incidence: the American Cancer Society estimated over 2 million new cancer cases in the U.S. in 2025 • Proxy for Advanced Cancer: Because MFWs arise almost exclusively in terminal or advanced disease, Destum used cancer - related mortality as a proxy for the annual advanced cancer population • MFW Incidence Rate: Literature reports that 5 - 14% of patients with advanced cancer develop MFWs. Destum applied a 9.5% rate to the ACS mortality estimate. • Longitudinal Trend: Long - term projections from Rahib et al, 2021 show that U.S. cancer mortality is expected to stabilize and then gradually decline through 2040 as demographic structure shifts and therapeutic outcomes improve. • Treatment Duration: Published evidence indicates MFWs typically occur in the final 6 - 12 months of life. Retrospective data shows many patients fall on the shorter end of this range (28.6% die within 1 month of onset, 66% within 6 months, and 75% within 12 months). Based on this, Destum used 6 months as an estimate of the treatment window. ▪ ~58,700 patients with malignant fungating wounds in the United States in 2025 Prevalence/Incidence (2025) • VT - 1953 will be the only FDA - approved therapy for MFW symptoms; KOL interviews revealed strong clinical interest, but real - world uptake may be limited by access constraints and entrenched off - label use of metronidazole ▪ 30% Peak Market Share • VT - 1953 is a topical product for palliative symptom relief rather than disease modification, aligning it with orphan wound - care and dermatology comparables. • Relevant comparators used in chronic or sensitive populations cluster in around $20/gram • A $9,125 per month WAC reflects VT - 1953's clinical role, maintains payer feasibility, and is consistent with price anchors across analogous typical products ▪ $20 per gram; $9,125 per month ▪ (7.5 g per application, BID) Annual WAC Price • Assumes standard rebates/discount structure for similar therapies and payer - negotiated pricing ▪ 20% Gross to Net Calculation Canva.com

![](ex99-1_018.jpg)

18 **Table of Contents** VT - 1953 for the Treatment of Symptoms of Malignant Fungating Wounds ▪ Background & Epidemiology ▪ Treatment Algorithm ▪ Competitive Landscape ▪ Total Treatable Patient Population ▪ Market Size & Potential ▪ Risk Assessments ▪ Forecast ▪ rNPV ▪ Summary

![](ex99-1_019.jpg)

19 U.S. Revenue Forecast for VT - 1953 Peak U.S. net sales for VT - 1953 are projected to reach $696 M in 2043 for the symptoms of MFW Based on this bottom - up model, incorporating modeled patient counts, treatment duration, and pricing assumptions, and a 30% peak market share, VT - 1953's modeled peak sales imply a total addressable pharmacologic MFW symptom - treatment market of approximately $2.2B in 2026 and growing to $2.8B in 2040 1. Destum Analysis 2043 2042 2041 2040 2039 2038 2037 2036 2035 2034 2033 2032 2031 2030 2029 Treatment of the Symptoms of Malignant Fungating Wounds 467.72 475.02 482.44 489.97 497.62 505.38 513.27 521.29 529.42 537.69 546.08 554.60 563.26 572.05 580.98 Advanced Cancer Cases (K) 44.43 45.13 45.83 46.55 47.27 48.01 48.76 49.52 50.30 51.08 51.88 52.69 53.51 54.35 55.19 Incident MFW Cases (K) 30% 30% 30% 30% 30% 30% 30% 30% 30% 30% 30% 30% 20% 10% 5% Market Share 13.33 13.54 13.75 13.96 14.18 14.40 14.63 14.86 15.09 15.32 15.56 15.81 10.70 5.43 2.76 Treated Patients (K) 79.98 81.23 82.50 83.78 85.09 86.42 87.77 89.14 90.53 91.94 93.38 94.84 64.21 32.61 16.56 Treatment Duration (Months) 55.99 56.86 57.75 58.65 59.56 60.49 61.44 62.40 63.37 64.36 65.37 66.39 44.95 22.82 11.59 Adherent Patients (70%) 839.79 852.90 866.22 879.74 893.47 907.42 921.58 935.97 950.58 965.42 980.49 995.79 674.23 342.37 173.86 Tubes Sold (K) $1,036 $1,005 $976 $948 $920 $893 $867 $842 $818 $794 $771 $748 $726 $705 $685 Unit WAC $869.72 $857.57 $845.59 $833.78 $822.13 $810.64 $799.32 $788.15 $777.14 $766.28 $755.58 $745.02 $489.74 $241.45 $119.04 Gross Sales (Millions USD) $695.78 $686.06 $676.47 $667.02 $657.70 $648.52 $639.46 $630.52 $621.71 $613.03 $604.46 $596.02 $391.79 $193.16 $95.23 U.S. Net Sales (80% gross to net, M USD)

![](ex99-1_020.jpg)

20 $455 $503 $551 $602 $1,086 $1,165 $1,346 $1,420 $1,499 $1,605 $1,674 $1,700 $1,727 $400 $200 $0 $600 $1,000 $800 $1,200 $1,400 600 $1, $1,800 $2,000 H1 2026 H2 2026 H1 2027 H2 2027 H1 2028 H2 2028 H1 2029 H2 2029 Phase 3 Completion Commercial Approval H1 2030 H2 2030 H1 2031 H2 2031 H1 2032 Asset Value ($mm) VT - 1953 – Value Over Time VT - 1953 currently has a value of $455M in the United States growing to over $1B in 2028 following completion of the Phase 3 trial Near - Term Value Inflection Points The initial NPV of VT - 1953 is estimated at $455M in the United States in H1 2026 with value inflection points in H1 2028 following completion of the Phase 3 trial, and in H1 2029 upon receiving commercial approval.

![](ex99-1_021.jpg)

21 $607 $661 $555 $517 $464 $455 $446 $346 $356 $394 $250 unt Rate S Disco ercial cPO D Comm enue R& Rev $0 $100 $200 $300 $400 $500 $600 $700 Value Millions Sensitivity analysis was performed on the U.S. value of VT - 1953. The model is most sensitive to revenue and discount rate, while being least sensitive to development costs. Sensitivity Analysis 20% Increase Base Case 20% Decrease SENSITIVITY ANALYSIS 1. Destum Analysis www.destumpartners.com ▪ To assess the robustness of the financial modeling, Destum performed sensitivity analyses ▪ To do this, a single parameter is increased (blue dots) or decreased (gray dots) by 20% while holding all others at their base value to observe the impact that deviating just one parameter has on the rNPV ▪ The rNPV here is most sensitive to changes in revenue. Holding all else equal, increasing revenue by 20% would lead to an rNPV of $661M, or a 45% increase from $455M. ▪ The model is quite insensitive to changes in R&D costs. Increasing R&D costs by 20% would lead to a $9M decrease in the rNPV from $455M to $446M

![](ex99-1_022.jpg)

22 Date Acquisition Details/Additional Notes Deal Value Upfront Indication(s) Stage Licensee Licensor March 2024 ZKN - 013 is a phase I ready oral therapy in recessive Dystrophic Epidermolysis Bullosa (RDEB), Junctional Epidermolysis Bullosa (JEB) and familial adenomatous polyposis (FAP). Upfront, development, regulatory, and sales milestones, as well as tiered royalties on future global sales. $473M $3M Rare Derm Diseases Phase I Ready Almiral Eloxx Jan 2023 Chiesi paid 107% premium on Amryt last closing price plus CVRs. Heavily driven by Oleogel - S10 which was approved in 2016 by the EMA for the treatment of partial thickness wounds in adults but not commercially launched . European Commission approval for the treatment of DEB and JEB granted in June 2022. Acquisition occurred shortly thereafter . $1.475B + $1.25B Rare Diseases/ EB (DEB / JEB) Commercial and Various Stages Chiesi (M & A) Amryt Pharma Jan 2021 Mar 2019 ProQR spins out all DEB activities (QR - 313 in exon 73 of the COL7A1 gene) into Wings Therapeutics formed and financed by EBRP; ProQR has a minority stake in Wings Therapeutics and is eligible for milestone and royalty rights to future sales. Phoenicis acquires Wings from ProQR and other shareholders (Undisclosed). Undisclosed Undisclosed Dystrophic Epidermolysis Bullosa (DEB) Phase 1/2 EB Research Partnership (EBRP) ProQR/Wings Therapeutics/ Phoenicis Aug 2016 Research collaboration focusing on gene therapy treatments (EB - 101) for EB; Philanthropy and potential commercial partnership with patient group and academic research center Undisclosed Undisclosed Epidermolysis Bullosa (EB) Phase 2 EBRP and EB Research Medical Foundation (EBMRF) Abeona Therapeutics Recent Comparable Transactions in a Rare Disease

![](ex99-1_023.jpg)

23 **Table of Contents** VT - 1953 for the Treatment of Symptoms of Malignant Fungating Wounds ▪ Background & Epidemiology ▪ Treatment Algorithm ▪ Competitive Landscape ▪ Total Treatable Patient Population ▪ Market Size & Potential ▪ Risk Assessments ▪ Forecast ▪ rNPV ▪ Summary

![](ex99-1_024.jpg)

24 $455 $503 $551 $602 $1,086 $1,165 $1,346 $1,420 $1,499 $1,605 $1,674 $1,700 $1,727 $400 $200 $0 $600 $1,000 $800 $1,200 $1,400 600 $1, $1,800 $2,000 H1 2026 H2 2026 H1 2027 H2 2027 H1 2028 H2 2028 H1 2029 H2 2029 Phase 3 Completion Commercial Approval H1 2030 H2 2030 H1 2031 H2 2031 H1 2032 Asset Value ($mm) VT - 1953 – Value Over Time VT - 1953 currently has a value of $455M in the United States growing to over $1B in 2028 following completion of the Phase 3 trial Near - Term Value Inflection Points The initial NPV of VT - 1953 is estimated at $455M in the United States in H1 2026 with value inflection points in H1 2028 following completion of the Phase 3 trial, and in H1 2029 upon receiving commercial approval.

![](ex99-1_025.jpg)

25 Summary Unmet Need • Malignant fungating wounds (MFWs) are a rare but devastating complication of advanced solid tumors, occurring predominantly in the final 6 - 12 months of life and associated with severe malodor, pain, exudate, bleeding, and psychosocial distress • Management is palliative and symptom - focused; no therapies address underlying inflammatory and microbial drivers of MFW symptoms, and wounds rarely heal • Patients and caregivers face high burden of care, frequent dressing changes, and social isolation, underscoring a significant unmet need in oncology wound care Market Landscape and Dynamics • There are no FDA - approved therapies indicated for the symptoms of malignant fungating wounds • Current management relies on fragmented, off - label interventions, each address individual symptoms with variable and incomplete effectiveness with difficulty to administer by clinicians, patients, and caregivers • Review of development pipelines did not identify any approved or late - stage investigational therapies targeting MFW symptoms VT - 1953 Market Positioning • VT - 1953 has the potential to be a first - in - class, indication - specific therapy for MFW symptom management • By targeting key inflammatory and microbial contributors to malodor and pain, VT - 1953 is designed to address multiple core symptoms with a single topical therapy • VT - 1953 is expected to complement and replace much of the off - label approaches to MFW symptom treatment • Pricing and access considerations are expected to meaningfully influence uptake, with KOLs highlighting the importance of affordability for their patients Program Value • Despite a relatively small patient population, the absence of direct therapeutic competition and high unmet need support meaningful clinical and commercial value • The base - case valuation of VT - 1953 by rNPV methodology is $455M in the United States as of as of Phase 2 completion and will grow to $1.086B H1 2028 following completion of the Phase 3 study • Based on Destum's bottom - up model, incorporating modeled patient counts, treatment duration, and pricing assumptions, and a 30% peak market share, VT - 1953's modeled peak sales imply a total addressable pharmacologic MFW symptom - treatment market of approximately $2.2B in 2026 and growing to $2.8B in 2040 in the United States • An optimal partner for VT - 1953 would have capabilities in oncology supportive or wound care, access to oncology, palliative, and hospice settings, and the ability to enable efficient market access and adoption for a novel therapy in this space (i.e., BMS, Pierre Fabre, Servier, Almirall, Helsinn, Horizon (Amgen), and Recordati Rare Disease to name a few) • Despite significant research, limited comparable transactions with publicly disclosed terms were identified

![](ex99-1_026.jpg)

26 Thank You Tom Filipczak Managing Director and Partner tfilipczak@destumpartners.com Ryan Zahn, MSPH MBA Senior Associate rzahn@destumpartners.com Kate Hutchinson, Ph.D. Associate khutchinson@destumpartners.com www.destumpartners.com

## Exhibit 99.2

**Exhibit 99.2**

**Independent Analyst Values Vyome's VT-1953 at USD 1 Billion Upon Successful Completion of Phase 3 Study**

● Third-party analysis estimates the total addressable U.S. market to be approximately USD 2.2 billion

● Modeled peak annual U.S. sales approaching USD 600 million for VT-1953

● Independent valuation analysis estimates post-Phase 3 asset value approaching USD 1 billion, and the current valuation with a positive Phase 2 is estimated to be USD 455 million

CAMBRIDGE, Mass. — Vyome Holdings, Inc. ("Vyome") (NASDAQ: HIND), a clinical-stage biopharmaceutical company focused on developing therapies for serious immuno-inflammatory and rare conditions, today announced key findings from an independent U.S. market assessment, commercial forecast, and valuation analysis commissioned by Vyome and conducted by Destum Partners, Inc. ("Destum Partners"), a reputed life sciences strategy and transaction advisory firm.

The independent analysis evaluated VT-1953, Vyome's lead clinical candidate for the treatment of symptoms of malignant fungating wounds (MFW), a rare and devastating complication of advanced solid tumors associated with severe malodor, pain, and profound psychosocial distress.

"Malignant fungating wounds represent one of the most severe and underserved conditions in oncology supportive care," said Tom Filipczak, Managing Director and Partner at Destum Partners. "Our team conducted rigorous primary and secondary research, including clinician interviews, epidemiology modeling, pricing benchmarking, and valuation analyses. Based on the absence of approved therapies and the high unmet need, we believe this indication represents a compelling clinical and commercial opportunity."

According to Destum Partners' comprehensive assessment, the total addressable pharmacologic market in the United States for malignant fungating wounds is estimated to be approximately USD 2.2 billion. Based on a bottom-up commercial model, estimated peak annual net sales for VT-1953 are approximately USD 600 million. Using a risk-adjusted net present value (rNPV) methodology, the estimated U.S. asset value as of now, with the successful and positive Phase 2 data, is projected to be USD 455 million, and following successful Phase 3 completion, is projected to approach USD 1 billion.

"This independent analysis reinforces our conviction in the potential of VT-1953," said Venkat Nelabhotla, Chief Executive Officer of Vyome. "We engaged a highly experienced third-party consulting firm to conduct a rigorous and unbiased assessment of the commercial opportunity for this program, where there are currently no FDA-approved drugs. Destum Partners' conclusion around the total addressable market in the U.S., together with the modeled potential peak sales and significant post-Phase 3 potential valuation, provides important external validation as we seek to advance VT-1953 toward pivotal development."

The analysis by Destum Partners incorporated extensive secondary research, epidemiology modeling, competitive landscape evaluation, pricing benchmarking, and primary research interviews with key opinion leaders across oncology, palliative care, wound care, and hospice settings.

**About Vyome Holdings, Inc.**

Vyome is building the world's premier platform spanning the US-India innovation corridor. Based in Cambridge, MA, Vyome's immediate focus is on leveraging its clinical-stage assets to transform the lives of patients with immuno-inflammatory conditions. By applying groundbreaking science and its unique positioning, Vyome seeks to deliver lasting value to shareholders in a cost-efficient manner while upholding global standards of quality and safety. To learn more, please visit www.vyometx.com

**About Destum Partners, Inc.**

Destum Partners is a boutique advisory and consulting firm dedicated to biopharma. Since 2006, Destum Partners has been providing clients with customized solutions that unlock value and optimize decision making. Its consulting practice is focused on market and product assessments and valuations across therapeutic areas, stage of development, modality, and geography. Destum Partners' advisory practice is focused on licensing, M&A, and R&D collaborations, and has completed over 40 transactions worth over USD $5.2B. To learn more, please visit www.destumpartners.com

**Forward-Looking Statements**

Certain statements made in this press release are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "target," "believe," "expect," "will," "shall," "may," "anticipate," "estimate," "would," "positioned," "future," "forecast," "intend," "plan," "project," "outlook", and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such statements, include, but are not limited to, statements contained in this press release relating to Vyome's business strategy, Vyome's future operating results and liquidity and capital resources outlook, the successful Phase 3 completion and anticipated expenses relating to the same, the total addressable pharmacologic market in the United States for malignant fungating wounds, and the estimated peak annual net sales for VT-1953. Forward-looking statements are based on Vyome's current expectations and assumptions regarding Vyome's business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Vyome's actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. Vyome cautions you, therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, Vyome's ability to protect Vyome's intellectual property rights; the impact of any infringement actions or other litigation brought against Vyome; competition from other providers and products; Vyome's ability to develop and commercialize products and services, including VT-1953; changes in government regulation; Vyome's ability to complete capital raising transactions; and other factors relating to Vyome's industry, operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Factors or events that could cause Vyome's actual results to differ may emerge from time to time, and it is not possible for Vyome to predict all of them. Vyome cannot guarantee future results, levels of activity, performance, or achievements. Vyome assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release, except as may be required under applicable securities law.

**Contacts**

contact@vyometx.com

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