Q3 2025 Vyome Holdings Inc Earnings Call
Operator: Good morning, welcome to the Vyome Holdings Inc. Q3 2025 Earnings Call. At this time, all participants are in a 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 Venkateswarlu Nelabhotla, co-founder, president, and CEO of Vyome Holdings. Please go ahead.
Operator: Good morning, welcome to the Vyome Holdings Inc. Q3 2025 Earnings Call. At this time, all participants are in a 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 Venkateswarlu Nelabhotla, co-founder, president, and CEO of Vyome Holdings. Please go ahead.
Speaker #1: Good morning and welcome to the VIOM Holdings Inc. third quarter 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.
Speaker #1: A full Safe Harbor disclosure appears in the company's press release. Now, I'd like to turn the call over to Venkat Nalabotra, co-founder of President and CEO of VIOM Holdings.
Speaker #1: Please go ahead.
Speaker #2: Thank you, Shimali. Good morning, everyone. I'm very happy to share VIOM'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.
Venkat Nelabhotla: 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 our lead program VT-1953 on schedule, and maintained the cost discipline central to our strategy.
Venkateswarlu Nelabhotla: 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 our lead program VT-1953 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 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.
Speaker #2: We completed a streamlined Nasdaq listing with a 100% common stock structure, advanced our lead program VT1953 on schedule, and maintained the cost discipline central to our strategy.
Speaker #2: Our runway extends through 2026 as planned, and I'm particularly pleased to share that our discipline spending model resulted in low cash burn, then we had anticipated.
Venkat Nelabhotla: Our runway extends through 2026 as planned, and I'm particularly pleased to share that our disciplined spending model resulted in 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.
Speaker #2: 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.
Speaker #2: 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.
Venkat Nelabhotla: 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 US and India innovation corridors gives us a strategic advantage.
Venkateswarlu Nelabhotla: 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 US 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, VT-1953. This quarter, we delivered encouraging interim phase 2 results for VT-1953, including symptoms of malodor and pain of malignant fungating wounds, or MFW. We saw a significant reduction in malodor, the primary endpoint measured by the Keeler Odor Scale.
Speaker #2: With a world-class team in place, we are focused on addressing information, one of the largest challenges in global health, representing an addressable market opportunity of more than 120 billion dollars.
Speaker #2: Our unique position bridging the US 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.
Venkat Nelabhotla: 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, VT-1953. This quarter, we delivered encouraging interim phase 2 results for VT-1953, including symptoms of malodor and pain of malignant fungating wounds, or MFW. We saw a significant reduction in malodor, the primary endpoint measured by the Keeler Odor Scale.
Speaker #2: Let me now turn now to our lead program VT1953. This quarter, we delivered encouraging interim phase two results for VT1953 in treating symptoms of malorder and pain of malignant fungating wounds or MFW.
Speaker #2: We saw a significant reduction in malorder, the primary endpoint measured by the Taylor order scale. Patients also reported less lesion pain on a visual analog scale and improved quality of life.
Venkateswarlu Nelabhotla: 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 VT-1953. For those unfamiliar with this condition, MFW is devastating. It affects 5 to 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 US, currently there are no FDA-approved treatments for MFW. Therefore, a potentially significant demand from clinicians and patients for VT-1953, with it anticipated to be the only approved drug. We are advancing it as a potential orphan drug candidate with full phase 2 data from our investigator-initiated trial expected in December 2025.
Venkat Nelabhotla: 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 VT-1953. For those unfamiliar with this condition, MFW is devastating. It affects 5 to 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 US, currently there are no FDA-approved treatments for MFW.
Speaker #2: Importantly, no clinically significant adverse effects were observed with VT1953. For those unfamiliar with this condition, MFW is devastating. It affects 5 to 14 percent 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.
Speaker #2: Representing a potential $1 billion addressable market opportunity in the United States, there are currently no FDA-approved treatments for MFW. Therefore, there is a potentially significant demand from clinicians and patients for VT1953, as it is anticipated to be the only approved drug.
Venkat Nelabhotla: Therefore, a potentially significant demand from clinicians and patients for VT-1953, with it anticipated to be the only approved drug. We are advancing it as a potential orphan drug candidate with full phase 2 data from our investigator-initiated trial expected in December 2025.
Speaker #2: 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.
Venkat Nelabhotla: These interim results validate our thesis that effective therapy can be developed through smartly designed and cost-efficient trials. Moving to our second program, VT-1908. We previously reported strong preclinical efficacy for VT-1908 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, VT-1908 eye drops significantly reduced the uveitis score.
Venkateswarlu Nelabhotla: These interim results validate our thesis that effective therapy can be developed through smartly designed and cost-efficient trials. Moving to our second program, VT-1908. We previously reported strong preclinical efficacy for VT-1908 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, VT-1908 eye drops significantly reduced the uveitis score. Notably, its efficiency was comparable to that of a clinically used steroid, underscoring the promise of VT-1908 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.
Speaker #2: Moving to our second program, VT1908. We previously reported strong preclinical efficacy for VT1908 eye drops in uveitis models. The reinforcing its promise as a highly needed steroid-sparing candidate.
Speaker #2: In a preclinical model of anterior uveitis, the most common form of the disease, twice daily, VT1908 eye drops significantly reduced the uveitis score. Notably, its efficiency was comparable to that of a clinically used steroid, underscoring the promise of VT1908 as a non-steroidal treatment option.
Venkat Nelabhotla: Notably, its efficiency was comparable to that of a clinically used steroid, underscoring the promise of VT-1908 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.
Speaker #2: 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 Oculo, an MIT spinout.
Venkateswarlu Nelabhotla: Beyond our novel drug pipeline, we are also exploring the development of an AI-focused healthcare initiative through the acquisition of Oculo, Inc., an MIT spin-out. To wrap up, with our clean 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, Craig Tooman, to discuss financials.
Venkat Nelabhotla: Beyond our novel drug pipeline, we are also exploring the development of an AI-focused healthcare initiative through the acquisition of Oculo, Inc., an MIT spin-out. To wrap up, with our clean 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, Craig Tooman, to discuss financials.
Speaker #2: So, to wrap up, with our keen 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.
Speaker #2: I'll now turn the call over to our CFO, Rob Dickey, to discuss financials.
Speaker #3: 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 dollars.
Craig Tooman: Thanks, Venkat, and good morning to everyone. I'll walk you through the financial highlights for the quarter ended 30 September. We ended the quarter with 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.
Rob Dickey: Thanks, Venkat, and good morning to everyone. I'll walk you through the financial highlights for the quarter ended 30 September. We ended the quarter with 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.
Speaker #3: 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 dollars primarily includes one-time transaction and non-cash financing charges associated with the merger.
Speaker #3: 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.
Rob Dickey: 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.
Speaker #3: 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.
Speaker #3: 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.
Craig Tooman: 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.
Speaker #2: Thanks, Rob. Today marks a defining step for VIOM. Our strategic pillars: biotech pipeline, AI-enabled healthcare, provide multiple pathways to innovation, growth, and value creation.
Venkat Nelabhotla: 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.
Venkateswarlu Nelabhotla: 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.
Speaker #2: 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.
Speaker #2: Thank you to our team, partners, and shareholders for their support. We look forward to sharing continued progress.
Speaker #2: you. Thank you, and that
Operator: Thank you. 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.
Operator: Thank you. 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.
Speaker #3: concludes today's PrePARE remarks. Please note that we will not be taking questions on this call. Any questions may be submitted via email to contact@viomtx.com.