MARKET WIRE NEWS

Vyome Reports Transformational 2025 Results: Company Well Positioned for Breakout Phase

MWN-AI** Summary

Vyome Holdings, Inc. (Nasdaq: HIND) has announced transformative results for 2025, marking a significant milestone in the company's evolution as a public entity. Following a successful Nasdaq listing via a merger transaction, Vyome is strategically positioned for a breakout phase in the biotechnology sector, primarily focusing on immuno-inflammatory diseases.

The company reported encouraging final Phase 2 results for its lead program, VT-1953, aimed at treating the distressing symptoms associated with malignant fungating wounds (MFW). This innovative topical treatment exhibited statistically significant improvements in reducing malodor and pain, with independent valuations estimating its potential market value at around $1 billion. With no existing FDA-approved treatments for MFW, Vyome’s success could address a substantial clinical need, as the condition impacts approximately one million cancer patients.

Throughout 2025, Vyome demonstrated disciplined operations, burning less cash than anticipated, which provides a financial runway extending into mid-2027 and covering expected pivotal trial interim analyses. The newly appointed executive team, with extensive backgrounds in major pharmaceutical companies, enhances Vyome’s capabilities in advancing clinical development.

Financially, the company reported approximately $4.94 million in cash and equivalents, alongside a net loss of $10.48 million, primarily due to one-time merger costs. However, the clean capital structure—free of preferred stock or debt—positions Vyome favorably for future growth.

Chairman Krishna Gupta emphasized the company's commitment to target significant inflammation-related challenges, while CEO Venkat Nelabhotla highlighted the operational efficiency and the substantial promise of their clinical programs. The company aims to deliver long-term value for shareholders and improve patient outcomes in the immuno-inflammatory space. A conference call is scheduled for March 30, 2026, to further discuss these promising developments.

MWN-AI** Analysis

Vyome Holdings, Inc. has unveiled promising results for its fiscal year 2025, signaling an optimistic outlook for investors. With the successful merger for a streamlined Nasdaq listing, Vyome has positioned itself for substantial growth, particularly with the encouraging Phase 2 results for its lead product, VT-1953. Notably, VT-1953 demonstrated a significant reduction in malodor and pain associated with malignant fungating wounds, a condition affecting many cancer patients.

The independent valuation of VT-1953 at around $1 billion highlights its potential as a unique market player, especially considering the projected $2.2 billion addressable market devoid of current FDA-approved treatments. This substantial unmet need further solidifies Vyome's strategic positioning within the immuno-inflammatory sector.

Furthermore, Vyome's disciplined operational approach is reflected in its cash management, with a runway extended through mid-2027. This financial stability allows the company to navigate upcoming pivotal trials without immediate funding constraints. Additionally, the recruitment of high-caliber personnel from Big Pharma adds depth to Vyome's strategic and operational capabilities, enhancing its prospects for further clinical advancements.

Investors should consider Vyome as a strong potential breakout opportunity, with the company's clean capital structure and promising drug pipeline providing a solid foundation for growth. The projected interactions with the FDA regarding pivotal study design will be crucial milestones to watch for, as they could drive investor sentiment and market valuations.

As Vyome proceeds with its plans and continues to meet key milestones, maintaining a close watch on their developments will be essential. This company exemplifies the intersection of innovative healthcare solutions and robust operational frameworks, making it a compelling consideration for any growth-focused portfolio.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: Business Wire
  • Completed a streamlined Nasdaq listing through a merger transaction, with a common stock capital structure and no preferred stock or debt
  • Delivered positive final Phase 2 results for VT-1953 in treating symptoms of malignant fungating wounds, in line with expectations
  • Independent valuation consulting firm, Destum Partners, valued VT-1953 at approximately $1 billion after a successful pivotal study
  • Disciplined, cost-efficient operations as Vyome burned less cash than expected, giving the company a cash runway expected to extend through mid 2027, taking it up to pivotal trial interim readouts
  • Added a new CTO, SVP of Clinical Development, and Senior Medical Advisor, bringing Big Pharma backgrounds, deep drug-development expertise, and experience across multiple FDA-approved therapies

Vyome Holdings, Inc., (“Vyome”) (Nasdaq: HIND), a next-generation inflammation-focused company leveraging the US-India innovation corridor, today announced its financial results and corporate and clinical milestones following its successful listing on Nasdaq.

This quarter marks Vyome’s first annual reporting period as a listed Nasdaq company. Vyome is a clinical-stage company positioned to accelerate development across immuno-inflammatory and potential orphan indications.

“Vyome is targeting one of the biggest challenges in the world today - inflammation. So many of our medical and mental problems are linked to increased inflammation. We are building our business with a laser focus on shareholder value, whether it’s our capital structure or the development of our assets,” said Krishna Gupta, Chairman of Vyome. “We had a great first fiscal year completion as a public company, thanks to our unique strengths, including expertise in/access to the US-India innovation corridor.”

“This annual reporting marks a defining step forward for Vyome. We executed a highly efficient transition to the public markets, spending less cash than expected in 2025 as a public company and strengthening our organization while advancing our lead program,” noted Venkat Nelabhotla, CEO of Vyome. “The promising final Phase 2 results for VT-1953 reinforce the scientific promise of our immuno-inflammation platform. With our disciplined operations, clean capital structure, and world-class team, we are well-positioned to deliver on the milestones ahead and drive long-term value for both shareholders and patients.”

VT-1953: Highly Encouraging Final Phase 2 Study Readouts

The Company’s lead clinical program, VT-1953, a novel, potential first-in-class topical product targeting symptoms of putrid smell and pain in malignant fungating wounds (“MFW”), which is an inflammatory condition afflicting an estimated one million cancer patients, continued to show strong clinical momentum.

  • Final Phase 2 Investigator-Initiated Study data demonstrated a statistically significant reduction in the study’s primary endpoint, malodor (P<0.002)
  • Patients also reported significant reductions in pain and improvements in quality of life
  • VT-1953 continues to show an excellent safety profile

Strong Progress on Milestones of VT-1953

  • The Company submitted an Orphan Drug Designation application to the FDA in January 2026
  • FDA interactions on pivotal study design and orphan drug designation are expected in the second quarter of 2026
  • Per an independent valuation analysis commissioned by Vyome and conducted by Destum Partners, Inc., treatment of malodor of MFW represents a potential addressable pharmacologic market opportunity of $2.2B in the U.S., with no FDA-approved drug; VT-1953 would be the only FDA approved solution on the market, with a potential valuation of $1B after a successful completion of a Phase 3 study

MFW is a devastating, rare condition affecting 5–14% of advanced cancer patients, often leading to severe emotional and social burden due to an extremely bad smell, which prevents any interaction with family or friends.

The Company previously reported strong preclinical efficacy for VT-1908 eye drops in uveitis models in the third quarter of 2025, reinforcing its promise as a highly needed steroid-sparing candidate in treating uveitis.

2025 Financial Summary

Cash Position

  • Total cash, cash equivalents, and short-term investments are approximately $4.94 million as of December 31, 2025, together with an additional financing of approximately $5.3 million in January 2026 from our ATM agreement, which is expected to cover our anticipated runway, including potential VT-1953 pivotal study interim analysis around mid-2027.

Operating Summary

  • R&D of $588,258 and G&A expenses of $2,365,565 reflect pre- and post-merger activities.
  • Net loss of $10,477,713 primarily reflects one-time merger and financing-related expenses of approximately $7.7 million, including non-cash charges associated with these transactions.

Clean Capital Structure

  • 5,919,337 outstanding shares of common stock
  • No preferred stock or debt

Company to Hold Conference Call to Review Results

The Company will host a conference call and webcast on Monday, March 30, 2026, at 11:00 a.m. ET to discuss the results. To access the webcast, please use the following link https://event.choruscall.com/mediaframe/webcast.html?webcastid=802ocw0n or dial in at 1-877-317-6789 (U.S./Canada toll-free) / +1-412-317-6789 (international).

A replay will be available on the Company Website.

About Vyome Holdings, Inc.:

Vyome is building the world’s premier platform spanning the US-India innovation corridor. 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 hyper cost-efficient manner while upholding global standards of quality and safety.

To learn more, please visit www.vyometx.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. 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 raise capital to fund continuing operations; our 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; changes in government regulation; and other factors relating to Vyome’s industry, operations and results of operations described in the Vyome’s Annual Report on Form 10-K for the year ended December 31, 2025, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K and subsequent filings with the SEC. 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.

SUMMARY FINANCIAL STATEMENTS
SUMMARY OF CONSOLIDATED BALANCE SHEETS AS OF ,

December 31, 2025

December 31, 2024

Cash and cash equivalents

$

4,982,333

$

101,904

Other current assets

455,988

200,142

Long term assets

1,058,856

1,079,515

Total assets

$

6,497,177

$

1,381,561

Liabilities

$

2,735,160

$

5,772,594

Total Stockholders’ equity (deficit)

3,762,017

(4,391,033

)

Total liabilities and stockholders’ equity

$

6,497,177

$

1,381,561

SUMMARY OF CONSOLIDATED STATEMENTS OF OPERATIONS

Year ended
December 31, 2025

Year ended
December 31, 2024

Revenues

$

319,714

$

256,944

Cost of goods sold

(100,943

)

(61,974

)

Gross profit

218,771

194,970

Operating expenses

2,965,808

1,201,310

Transactional and financial advisory fees including non-cash expenses

7,705,533

-

Operating loss

(10,452,570

)

(1,006,340

)

Interest and other expenses, net

(25,143

)

(441,121

)

Net loss

$

(10,477,713

)

$

(1,447,461

)

View source version on businesswire.com: https://www.businesswire.com/news/home/20260326931929/en/

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FAQ**

How does Vyome Holdings Inc. HIND plan to leverage its successful Phase 2 results for VT-1953 to attract future investors and expand its market presence in the pharmacologic market opportunity estimated at $2.2 billion?
Vyome Holdings Inc. plans to leverage its successful Phase 2 results for VT-1953 by highlighting its efficacy and safety profile to attract investors, aiming to secure funding for further development and marketing efforts in the burgeoning $2.2 billion pharmacologic market.
With a clean capital structure and the absence of preferred stock or debt, how does Vyome Holdings Inc. HIND intend to utilize its cash runway that extends through mid-20to advance its clinical programs and overall business strategy?
Vyome Holdings Inc. plans to strategically utilize its cash runway through mid-2027 to advance its clinical programs, enhance research and development initiatives, and execute its overall business strategy without the encumbrance of debt or preferred stock.
In light of the positive final Phase 2 results for VT-195what specific milestones does Vyome Holdings Inc. HIND aim to achieve in the upcoming pivotal study, and how will these milestones impact shareholder value?
Vyome Holdings Inc. aims to achieve regulatory approval and successful patient recruitment milestones in its pivotal study for VT-1953, which could enhance market confidence, drive stock performance, and ultimately increase shareholder value significantly.
Given the introduction of key leadership with Big Pharma backgrounds, how does Vyome Holdings Inc. HIND plan to capitalize on this expertise to ensure the successful transition of VT-1953 into the next phases of clinical development and potential FDA approval?
Vyome Holdings Inc. plans to leverage the leadership's Big Pharma experience to streamline clinical development processes, enhance strategic partnerships, and ensure compliance with regulatory standards, ultimately driving VT-1953 towards successful FDA approval.

**MWN-AI FAQ is based on asking OpenAI questions about Vyome Holdings Inc. (NASDAQ: HIND).

Vyome Holdings Inc.

NASDAQ: HIND

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