Vyome Holdings Reports First Quarter 2026 Results With Key FDA Filings and Strong Balance Sheet

Key Terms

orphan drug designation regulatory

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

pharmacokinetic medical

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

phase 2 medical

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

pivotal-stage medical

Pivotal-stage describes the late, definitive round of clinical testing designed to show whether a drug or medical device works and is safe enough for regulators to approve it. Think of it like a final exam for a new treatment: passing it clears the main obstacle to market access, while failing it can halt commercial prospects. Investors watch this stage closely because its outcome strongly affects a product’s chance of approval, potential sales, and company valuation.

malignant fungating wounds medical

Malignant fungating wounds are open, often damaged patches of skin and tissue that develop when an advancing cancer breaks through the skin, leading to pain, odor, bleeding and high infection risk. Investors care because these wounds drive demand for specialized wound-care products, palliative drugs, medical devices and home care services; like a house with a chronic leak, they create ongoing treatment costs, regulatory scrutiny and potential market opportunity for better therapies.

american association for cancer research medical

A leading professional organization that supports and promotes cancer research by funding studies, publishing scientific journals and hosting conferences where researchers share new findings. Think of it as a central marketplace for scientific news: companies and labs present data and early results there, and those disclosures can change expectations about a drug’s chances or spark partnerships. Investors monitor its meetings and publications because new positive findings or collaborations announced through the group can move biotech and pharmaceutical stock values.

jak inhibitor medical

A JAK inhibitor is a type of medicine that blocks Janus kinase enzymes, which help cells send signals that drive inflammation and immune activity. By turning down that cellular “volume knob,” these drugs can reduce symptoms in autoimmune diseases and certain blood disorders. Investors watch JAK inhibitors because their effectiveness, safety profile, approval status, and patent position directly affect drug sales, market competition, and regulatory risk for companies developing or selling them.

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• Vyome has signed an agreement with Impetis Biosciences Limited, a TATA Enterprise, to in-license two selective JAK inhibitor assets, opening access to a large and growing ~$57B global market¹
• VT-1953 regulatory submissions to the FDA for Orphan Drug Designation status and proposals for constructive FDA guidance on the next steps of development
• Company ends Q1 2026 with approximately $8.8 million in cash and cash equivalents while maintaining a clean capital structure with no debt, no preferred stock, and no toxic financing instruments

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vyome Holdings, Inc. (Nasdaq: HIND)(“Vyome”), a clinical-stage biopharmaceutical company focused on immuno-inflammatory and rare disease conditions, today reports financial results for the first quarter ended March 31, 2026, and provides a corporate update.

Krishna Gupta, Chairman of Vyome, said, “Over the last several quarters, Vyome has executed with focus and discipline, advancing differentiated programs in areas of significant unmet medical need focused on inflammatory disorders. Inflammation remains one of the world’s largest problems, and we believe Vyome is well positioned for long-term value creation. We continue to strengthen our scientific, operational, and governance foundation while remaining highly disciplined on capital structure and shareholder alignment.”

Venkat Nelabhotla, CEO of Vyome, stated, “We continue to advance VT-1953 toward pivotal-stage readiness while maintaining a strong focus on disciplined execution, regulatory engagement, manufacturing preparedness, and financial stewardship. We submitted to the FDA an application for the approval of orphan drug designation status and proposals across several areas of the next stages of development readiness, and continue to believe VT-1953 addresses a major unmet need in malignant fungating wounds, where there are currently no FDA-approved therapies specifically addressing the condition.”

“Importantly, we have continued to preserve what we believe is one of the Company’s key differentiators: a clean and disciplined capital structure with no debt, no preferred stock, and no toxic financing instruments. We remain focused on creating long-term shareholder value while advancing our immuno-inflammatory and rare disease strategy,” concluded Mr. Nelabhotla.

First Quarter 2026 and Recent Corporate Highlights

• Regulatory submissions with the FDA related to VT-1953 pivotal development readiness, including discussions involving manufacturing, toxicology, pharmacokinetic requirements, and clinical development considerations. Filed an Orphan Drug Designation application with the FDA
• Continued advancement of VT-1953 for malignant fungating wounds, a condition associated with significant unmet medical need and no FDA-approved therapies specifically addressing the condition
• Raised approximately $5.29 million in gross proceeds through the sale of 1,089,545 common shares on January 27, 2026, at an average price of $5.00 per share, representing a 59.2% premium to the prior day’s closing price, with total dilution to existing shareholders of approximately 15%
• Continued scientific and translational activities supporting VT-1908 and broader immuno-inflammatory initiatives
• Presented positive VT-1953 Phase 2 clinical study data at the prestigious American Association for Cancer Research (AACR) 2026
• Entered into a strategic in-licensing agreement with Impetis Biosciences Limited, a TATA Enterprise, for selective JAK inhibitor assets under a capital-light structure with payments at commercialization, and development using non-dilutive pathways

Financial Results for the Quarter Ended March 31, 2026

• Cash and cash equivalents were approximately $8.8 million as of March 31, 2026, compared with approximately $5.0 million as of December 31, 2025
• Total assets were approximately $10.2 million as of March 31, 2026
• Total stockholders’ equity was approximately $8.0 million as of March 31, 2026
• Total operating expenses for the quarter ended March 31, 2026, were approximately $1.1 million, including approximately $666,000 in research and development expenses and approximately $478,000 in selling, general, and administrative expenses
• Net loss attributable to common shareholders for the quarter ended March 31, 2026, was approximately $963,000, or approximately $0.15 per basic and diluted share

The Company will also host a conference call and webcast on Wednesday, June 3, 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=531gpp9T or dial in at 1-877-317-6789 (U.S./Canada toll-free) or +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, the anticipated timing and outcome of regulatory submissions to the FDA, 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 Securities and Exchange Commission. 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 CONDENSED CONSOLIDATED BALANCE SHEETS AS OF
	March 31, 2026			December 31, 2025
Cash and cash equivalents	$	8,795,783		$	4,982,333
Other current assets		366,799			455,988
Long term assets		1,022,864			1,058,856
Total assets	$	10,185,446		$	6,497,177
Liabilities	$	2,144,125		$	2,735,160
Total Stockholders’ equity (deficit)		8,041,321			3,762,017
Total liabilities and stockholders’ equity	$	10,185,446		$	6,497,177

SUMMARY OF CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
	Three months ended March 31, 2026				Three months ended March 31, 2025
Revenues	$	31,591			$	198,581
Cost of goods sold		(14,946	)			(44,162	)
Gross profit		16,645				154,419
Operating expenses		1,146,585				353,417
Operating loss		(1,129,940	)			(198,998	)
Interest and other expenses, net		144,419				(94,976	)
Net loss	$	(985,521	)		$	(293,974	)

¹https://www.researchandmarkets.com/report/jak-inhibitor?srsltid=AfmBOoonOb9NkQoIR8mj_k-Nb-XVnCirMY73UDt2qTp7k7IFfvbe41hi

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Source: Vyome Holdings, Inc.