First-in-class RNA medicines, from lab to clinic.

Stress urinary incontinence (SUI) is a chronic, debilitating disease affecting 1 in 3 women, with current standard of care limited to physical therapy and highly invasive surgical procedures — there are no FDA-approved therapeutics. Women with SUI are 4–9x more likely to suffer from depression or anxiety, and 88% of severe cases report a significant impact on work. Conservative pricing suggests peak sales potential above $10 billion.

VMB-100, ValamAi’s engineered IGF-I mRNA candidate, is delivered by intra-urethral injection into the sphincter muscle. In a rat SUI model (vaginal distention injury), a single intra-urethral injection of 10 µg VMB-100 demonstrated substantial regeneration of the urinary sphincter muscle. VMB-100 has received FDA IND clearance, with a Phase IIa safety and Phase IIb efficacy & dose-finding study in women with SUI planned for Q1 2027.

Building on the same regenerative mechanism validated in SUI, ValamAi is expanding VMB-100 into disc herniation via intra-disc injection. In a rabbit disc herniation model, treatment reduced the loss of disc height index versus vehicle over 90 days post-injury, supporting further indication expansion of the IGF-I mRNA platform into orthopedic and spine applications.

Topical treatment is strongly preferred over systemic therapy in dermatology, yet topical formulations have historically been limited to small molecules — leaving roughly 85–90% of proteins undruggable by classical small-molecule approaches. ValamAi’s VAI-002 is a topical RNA cream in development for androgenetic alopecia (hair loss), part of a broader dermatology strategy that also spans acne, melasma, wrinkles, psoriasis, atopic dermatitis and vitiligo.

RNA combined with topical formulation is a novel, largely uncontested niche, with the potential for a faster path to market than systemic RNA therapies.

VAI-003 combines mRNA and siRNA in a single molecule, modulating the local tumor environment through simultaneous upregulation and suppression of different targets in a correctly balanced biological ratio. The biological mechanisms targeted are scientifically validated and apply to solid tumor types where current treatments have limited efficacy, and ValamAi’s combinatorial approach aims to bring a solution to difficult-to-treat disease.