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Vyome Appoints Renowned Medical Oncologist, Dr. Aditya Bardia, as Senior Medical Advisor to Guide the Development of MFW Program

Dr. Bardia has led the clinical development and FDA approvals of multiple blockbuster drugs

Vyome Holdings, Inc. (“Vyome”) (NASDAQ: HIND), a clinical-stage healthcare holding company, today announced Dr. Aditya Bardia as Senior Medical Advisor to Vyome. In this consulting role, Dr. Bardia will guide the clinical development of Vyome’s lead asset, VT-1953, for the treatment of symptoms of malignant fungating wounds (MFW), a debilitating condition in cancer patients for which approval is being targeted in 2026.

“I am excited to work with Vyome team and guide the clinical development of VT-1953 for the treatment of symptoms of malignant fungating wound, a debilitating condition that can significantly impair quality of life for patients with cancer,” said Dr. Bardia. “In my clinical practice, I have seen patients suffer from this horrible condition, and we really need an effective treatment for this major unmet clinical need. I am encouraged by the preliminary data with VT-1953 in MFW, and the mechanistic basis for this therapy. This is the perfect opportunity to develop a first-in-class therapy, which can improve the quality of life for patients with cancer.”

Dr. Bardia has led clinical trials that have resulted in many drug approvals, including Sacituzumab Govitecan, Trastuzumab Deruxtecan, and Datopotamab Deruxtecan, which became blockbuster drugs. Dr. Bardia also led the clinical development of Elacestrant, the first oral SERD approved for patients with metastatic HR+ positive breast cancer. Trained at Johns Hopkins in medical oncology, Dr. Bardia joined Massachusetts General Hospital-Harvard Medical School as a faculty member before moving to David Geffen School of Medicine at UCLA and the UCLA Health Jonsson Comprehensive Cancer Center as Professor and director of the Breast Cancer Program and Translational Research Integration. He has also received numerous awards and honors.

“Dr. Bardia’s expertise in having led the development of multiple drugs and especially steering them through accelerated FDA approvals aligns with our strategy of designing robust, but cost-efficient, trials,” said Dr. Shiladitya Sengupta, Associate Professor of Medicine, Harvard Medical School, and Co-Founder of Vyome. “We are delighted that Dr. Bardia decided to work with the Vyome team, significantly bolstering our depth in developing next-generation therapies, as we embark on pivotal studies with our lead asset.”

“The collaboration with Dr. Bardia marks an important milestone in Vyome’s growth journey. We have a brilliant team in place to unlock the next milestones of value in our lead program,” said Venkat Nelabhotla, CEO of Vyome.

About MFW

MFW is a debilitating condition that occurs in 5-14% of advanced cancer patients, and it’s estimated that there are over 650,000 patients with advanced cancer in the US, with approximately 10 million patients globally. These numbers were recently confirmed in the latest research published in June 2025(1). Cancer cells break through the skin and cause a chronic wound (MFW), which is extremely distressing to patients, given the high burden of symptoms, including extreme malodor, severe pain, a feeling of shame, low self-esteem, and social isolation(2).

VT-1953 topical gel is designed to treat the symptoms of MFW by targeting the cause of malodor and inhibiting the drivers of inflammation. In prior clinical studies, VT-1953 topical gel has been well tolerated in over 500 patients. In the interim analysis, VT-1953, which exerts an immuno-anti-inflammatory effect by targeting TLR-MD2 and DNA gyrase, significantly reduced malodor symptom (P<0.001), as scored by clinical investigators using a TELER Odor scale, the primary endpoint in this interim analysis. Patients also reported a significant reduction in lesion pain scored on a visual analog scale (VAS) (P<0.001) and an improvement in quality of life (P<0.001), both secondary and exploratory end points, respectively, in the study. No clinically significant adverse trends were noted with VT-1953 administration(3).

References:

(1) Daniela Nigrelli, Francesca Gambalunga, Giuliano Anastasi, Angela Peghetti, Stefano Durante, Martina Giusti, Valentina Biagioli, Silvio Quirini, Laura Iacorossi, Roberto Latina. Malignant fungating wounds assessment in palliative care: a scoping review

https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1602493/full

(2) Alexander, S.J. An intense and unforgettable experience: the lived experience of malignant wounds from the perspectives of patients, caregivers and nurses. International Journal of Woundcare. 2010, 7:456-465

https://aacrjournals.org/cancerres/article/85/8_Supplement_2/CT091/761756/Abstract-CT091-Interim-results-from-a-phase-2

(3) Arshit Narang, Prashant Prakash Lad, Shiladitya Sengupta. Interim results from a phase 2 trial testing the safety and efficacy of VT-1953 topical gel in patients with malodorous malignant fungating wounds [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT091.

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 across the US-India innovation corridor, 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; 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.

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