-- 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
CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 26, 2026--
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 Year ended
December 31, 2025 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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March 26, 2026 08:00 ET (12:00 GMT)