Vyome Holdings - Earnings Call - Q3 2025

Executive Summary

• Q3 2025 marked Vyome’s first full reporting period as a Nasdaq-listed company; management highlighted a “clean capital structure,” cash of $5.7M, and an expected cash runway through year-end 2026, aided by disciplined spend and lower-than-expected cash burn.
• Clinical execution was the key positive: interim Phase 2 data for lead asset VT-1953 in malignant fungating wounds showed statistically significant malodor reduction (P<0.001), pain improvement, and QoL gains; FDA interactions for a pivotal design and orphan path are planned in 1H26, with a fuller Phase 2 data update expected in early December 2025.
• Strategic expansion into AI: Vyome acquired MIT spinout Oculo and launched an AI unit (targeting “AI psychiatrist” initiatives) while stating this will not slow core biotech assets; funding runway remains through 2026.
• Stock reaction catalysts: early-December Phase 2 readout for VT-1953; clarity on pivotal study design/orphan path in 1H26; continued AI strategy progress; and any capital strategy updates given one-time transaction charges and small revenue base.

What Went Well and What Went Wrong

What Went Well

• VT-1953 delivered highly encouraging interim Phase 2 results (malodor reduction P<0.001, plus pain and QoL improvements), with strong safety; management plans FDA discussions for a pivotal path and orphan designation in 1H26 and flagged a Phase 2 readout update in early December 2025.
• Strategic positioning and message discipline: “We executed a highly efficient transition to the public markets, spending less cash than expected… advancing our lead program,” said CEO Venkat Nelabhotla; Chairman Krishna Gupta emphasized a “laser focus on shareholder value” and the US–India innovation corridor.
• Clean capital structure and organizational upgrades: 5,556,295 shares outstanding, no preferred or “toxic” instruments; new CTO and SVP of Clinical Development added, with Big Pharma backgrounds.

What Went Wrong

• Limited commercial scale and heavy one-time costs: Nine-month revenue was $0.28M while transactional/financial advisory fees totaled $7.71M, driving a nine-month operating loss of $9.10M and net loss of $9.20M.
• Lack of traditional quarterly metrics disclosure: The press release did not provide quarterly revenue/EPS/margin detail or non-GAAP reconciliation; investors have limited visibility on operating cadence this quarter.
• Capital dependency remains a key risk per forward-looking statements (ability to raise capital, protect IP, and navigate competition/regulation), underscoring financing execution risk into 2026 despite current runway.

Transcript

Operator (participant)

Good morning and welcome to the Vyome Holdings Q3 2025 earnings call. At this time, all participants are in listen-only mode. Please note that today's discussion may include forward-looking statements, which are subject to risks and uncertainties. A full safe harbor disclosure appears in the company's press release. Now, I'd like to turn the call over to Venkat Nalabhotra, co-founder, President, and CEO of Vyome Holdings. Please go ahead.

Venkat Nelabhotla (Co-founder, President, and CEO)

Thank you, Shimali. Good morning, everyone. I'm very happy to share Vyome's first full reporting period as a publicly listed company. This quarter marks a significant step forward for our organization, and I'm pleased to report we are executing according to plan. We completed a streamlined NASDAQ listing with a 100% common stock structure, advanced early program VT1953 on schedule, and maintained the cost discipline central to our strategy. Our runway extends through 2026 as planned, and I'm particularly pleased to share that our disciplined spending model resulted in a lower cash burn than we had anticipated, demonstrating our operational efficiency while advancing our programs. On the team front, we strengthened our leadership by hiring a Chief Technology Officer and Senior Vice President of Clinical Development, both bringing big pharma backgrounds, deep drug development expertise, and experience across multiple FDA-approved therapies.

These additions strengthen our ability to execute on our pipeline programs. With a world-class team in place, we are focused on addressing inflammation, one of the largest challenges in global health, representing an addressable market opportunity of more than $120 billion. Our unique position, bridging the U.S. and India innovation corridors, gives us a strategic advantage. It provides access to world-class scientific talent, cost-efficient clinical trial infrastructure, and diverse patient populations, enabling us to develop therapies more rapidly and economically than traditional models while maintaining rigorous regulatory standards. Let me turn now to our lead program, VT1953. This quarter, we delivered encouraging interim phase two results for VT1953 in treating symptoms of malodor and pain of malignant fungating wounds, or MFW. We saw a significant reduction in malodor, the primary endpoint, measured by the Killer-Oder scale.

Patients also reported less lesion pain on a visual analog scale and improved quality of life. Importantly, no clinically significant adverse effects were observed with VT1953. For those unfamiliar with this condition, MFW is devastating. It affects 5%-14% of advanced cancer patients and often leads to severe emotional and social isolation due to extremely malodorous wounds that prevent interaction with family and friends. Representing a potential $1 billion addressable market opportunity in the United States, currently, there are no FDA-approved treatments for MFW. Therefore, a potentially significant demand from clinicians and patients for VT1953, with it anticipated to be the only approved drug. We are advancing it as a potential orphan drug candidate with full phase two data from our investigator-initiated trial expected in December 2025. These interim results validate our thesis that effective therapies can be developed through smartly designed and cost-efficient trials.

Moving to our second program, VT1908. We previously reported strong preclinical efficacy for VT1908 eye drops in uveitis models, reinforcing its promise as a highly needed steroid-sparing candidate. In a preclinical model of anterior uveitis, the most common form of the disease, twice daily, VT1908 eye drops significantly reduce the uveitis score. Notably, its efficacy was comparable to that of a clinically used steroid, underscoring the promise of VT1908 as a non-steroidal treatment option. FDA interactions are planned for the first half of 2026, alongside continued development activities to advance the program toward clinical readiness. Beyond our novel drug pipeline, we are also exploring the development of an AI-focused healthcare initiative through the acquisition of Oculos and MIT Spinout.

To wrap up, with our king capital structure, disciplined operations, and world-class team, we are well positioned to deliver on upcoming milestones and drive long-term value for both patients and shareholders. I'll now turn the call over to our CFO, Rob Dickey, to discuss financials.

Rob Dickey IV (CFO)

Thanks, Venkat, and good morning to everyone. I'll walk you through the financial highlights for the quarter ended September 30. We ended the quarter with cash, cash equivalents, and short-term investments totaling approximately $5.7 million, which we believe provides a runway through 2026, inclusive of planned clinical activities. Research and development and general administrative expenses reflect pre- and post-merger costs, and the net loss of $9.2 million primarily includes one-time transaction and non-cash financing charges associated with the merger. As noted in our press release, our outstanding common shares count stood at 5,556,295 shares, and we have no preferred stock, warrants, or convertible notes outstanding, maintaining a clean capital structure. Our disciplined spending model resulted in lower cash burn than anticipated, a development that we're pleased with given our strategic focus. Looking ahead, we remain committed to cost-efficient operations as we advance our pipeline.

I will now turn the call back to Venkat for closing remarks.

Venkat Nelabhotla (Co-founder, President, and CEO)

Thanks, Rob. Today marks a defining step for Vyome. Our strategic pillars, biotech pipeline, AI-enabled healthcare, provide multiple pathways to innovation, growth, and value creation. With our programs now in motion and regulatory engagement planned for the first half of 2026, we enter the next phase with momentum and clarity. Thank you to our team, partners, and shareholders for their support. We look forward to sharing continued progress. Thank you.

Operator (participant)

Thank you, and that concludes today's prepared remarks. Please note that we will not be taking questions on this call. Any questions may be submitted via email to [email protected]. Thank you for your participation in Vyome Holdings Q3 2025 earnings call.