Reported Earnings • May 14
First quarter 2026 earnings released First quarter 2026 results: US$0.14 loss per share. Net loss: US$962.9k (loss widened 228% from 1Q 2025). Revenue is forecast to grow 73% p.a. on average during the next 3 years, compared to a 8.7% growth forecast for the Pharmaceuticals industry in the US. Announcement • Apr 24
Vyome Holdings, Inc. Presents Transformational VT-1953 Phase 2 Clinical Study Data Vyome Holdings, Inc. presented its full Phase 2 investigator initiated study results and preclinical data supporting the efficacy and safety of VT-1953 as a potential treatment for symptoms of Malignant Fungating Wounds (MFW) at the 2026 American Association for Cancer Research (AACR) Annual Meeting in San Diego, on April 21, 2026. VT-1953 topical gel significantly reduced MFW-associated severe malodor over a 14 Day period (P=0.0020) as scored by investigators. VT-1953 efficacy was significantly superior to the vehicle control (P= 0.0015). 70% of patients treated with VT-1953 vs 0% of patients treated with vehicle (control arm) reported an improvement in patient-reported outcome measure of impact of malodor on life by Day 14 (P= 0.0256). Patients treated with VT-1953 reported a clinically significant 2 point improvement in lesion pain by Day 14 (p= 0.0020) as scored using a 10-point VAS scale. No change seen in vehicle-treated arm. No treatment-emergent adverse effects were reported in this Phase 2 study. MFWs are non-healing wounds that occur in ~10% of advanced cancer patients (~65,000 patients in the U.S. alone each year). Patients suffer symptoms such as severe ‘rotten meat’ malodor, pain, which negatively impacts quality of life. There are currently no FDA approved drugs to treat these symptoms of MFW. Vyome is developing VT-1953 as a first in class treatment for symptoms of MFW. VT-1953 acts by dual mechanism of action, inhibiting DNA Gyr and modulating MD2/TLR interactions, an inflammatory signal. In the Ph2 study, advanced cancer patients with MFW who scored at a median 0.5 (corresponding to extreme malodor that is detected 6-10ft away with dressing on) at start of treatment with VT-1953 improved (P=0.0020) to a median score of 4 (mild odor detectable up close only after removing dressing) by Day 14 on a TELER scale of 0-5 scored by clinical investigator (Primary endpoint). MFW patients treated with the vehicle as a control arm showed no improvement in malodor (median score remained the same on Day 14 as Day 1; P=0.9999). VT-1953 treatment was significantly superior to the control arm (P = 0.0015). On a secondary endpoint, where patients were asked to score the impact of malodor on their life, 70% of patients treated with VT-1953 reported an improvement to a score range of 3 to 5 by Day 14 from a baseline score of 0, as compared with 0% of patients in the vehicle-treated arm (P = 0.0256). Patients were also asked to score the level of malodor on a 10-point visual analog scale, where 0 was no smell, while 10 was the worst smell. Treatment with VT-1953 gel treatment group improved the median score from 7.5 at the start of treatment to 2.5 by Day 14, a significant improvement (p=0.0020) from baseline. Patients treated with the vehicle reported an increase (worsening) in median malodor score from 6.0 at baseline to 7.0 by Day 14 (p=0.0625). Patients treated with VT-1953 also reported a clinically significant 2-point improvement in lesion pain by Day 14 (p= 0.0020) as scored using a 10-point VAS scale, while patients treated with vehicle reported no improvement from baseline score. Treatment did not change exudate levels. There were no treatment-associated adverse effects reported. Announcement • Apr 07
Vyome to Present Compelling Phase 2 Clinical Data on VT-1953 for Treatment of MFW at AACR 2026 Vyome Holdings, Inc. announced that the company will present its full Phase 2 investigator initiated study results and preclinical data supporting the efficacy and safety of VT-1953 as a potential treatment for malodor and other symptoms of Malignant Fungating Wounds (MFW) at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place on April 17-22, 2026, in San Diego. The research will be presented at the session “Phase II and Phase III Clinical Trials in Progress.” Vyome will highlight mechanistic insights together with detailed clinical data comparing the VT-1953 active treatment with vehicle treatment in a Phase 2 study. VT-1953 is a first-in-class treatment for malodor and other symptoms of MFW in advanced cancer patients, which acts by a dual mechanism of action, inhibiting DNA Gyr and modulating MD2/TLR interactions, an inflammatory signal. MFW is a rare, debilitating condition that occurs in ~10% of advanced cancer patients, severely impacting the quality of life. The details of the presentation at the 2026 AACR Annual Meeting are: American Association for Cancer Research Annual Meeting 2026, San Diego. Date: April 21, 2026, 9:00 AM - 12:00 PM. Session title: (PO.CTP01.03) Phase II and Phase III Clinical Trials in Progress. Presentation number and title: CT208 /3 - Final results from a phase 2 trial testing safety and efficacy of VT-1953 topical gel in patients with malodorous malignant fungating wound. Authors: Arshit Narang, MBBS, Prashant Prakash Lad, MD, Shiladitya Sengupta PhD.