Vyome Holdings Q3 2025 Earnings Call - Advancing VT1953 With Solid Interim Phase 2 Data and Disciplined Financials
Summary
Vyome Holdings reports its first full quarter as a publicly listed entity with signs of operational discipline and pipeline progress. The lead candidate VT1953 showed promising interim phase two data for malignant fungating wounds, a neglected condition with no FDA-approved treatments, potentially opening a $1 billion U.S. market. Management highlights a streamlined NASDAQ listing, a clean capital structure, and cash runway through 2026, underscoring financial prudence amid clinical advancement. The company bolsters its ranks with experienced biotech executives and plans FDA interactions on its uveitis eye drop candidate, VT1908, in early 2026. Vyome also signals an AI-healthcare initiative through acquisitions, diversifying its innovation avenues.
Key Takeaways
- Vyome Holdings completed its first full reporting period as a public company with a streamlined NASDAQ listing and a 100% common stock structure.
- The company’s lead program, VT1953, showed encouraging interim phase two results, significantly reducing malodor in malignant fungating wounds (MFW), the primary endpoint.
- Patients on VT1953 also reported less lesion pain and improved quality of life, with no clinically significant adverse effects observed.
- MFW affects 5%-14% of advanced cancer patients and currently has no FDA-approved treatments, representing a potential $1 billion U.S. market opportunity.
- Vyome is advancing VT1953 as a potential orphan drug with full phase two data expected by December 2025 from an investigator-initiated trial.
- Second program VT1908, for anterior uveitis, demonstrated strong preclinical efficacy comparable to steroids and is progressing towards FDA interactions planned for the first half of 2026.
- The company maintained strong cost discipline, resulting in lower cash burn than anticipated, with a cash runway expected through 2026 inclusive of planned clinical activities.
- Vyome expanded its leadership team by hiring a Chief Technology Officer and Senior Vice President of Clinical Development with big pharma experience.
- The company is exploring an AI-focused healthcare initiative through acquisitions, including Oculos and an MIT Spinout, diversifying its pipeline beyond biotech.
- Vyome holds a clean capital structure with approximately 5.56 million common shares outstanding and no preferred stock, warrants, or convertible notes.
- Management emphasized the strategic advantage of bridging U.S. and India innovation corridors, accessing cost-efficient trial infrastructure and diverse patient populations.
- No Q&A session was held in the earnings call; investors were directed to submit questions via email.
Full Transcript
Shimali, Call Moderator, Vyome Holdings: 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 Nalabhotra, Co-Founder, President, and CEO, Vyome Holdings: 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, CFO, Vyome Holdings: 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 Nalabhotra, Co-Founder, President, and CEO, Vyome Holdings: 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.
Shimali, Call Moderator, Vyome Holdings: 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 contact@vyometx.com. Thank you for your participation in Vyome Holdings Q3 2025 earnings call.