That means momentum is already building now — and the Phase 3 window is just months away.
Add in the current backdrop — where larger players are looking to partner or acquire NMIBC pipeline assets — and the market starts drawing lines forward.
💊 But That’s Not All: Sepranolone Adds a Second Major
Catalyst
Relmada isn’t a one-program pony.
Behind NDV-01 is sepranolone, a novel compound showing promise in compulsivity-linked disorders like: (2)(3)(5)
🧠 Prader-Willi Syndrome
🧠 Tourette Syndrome
🧠 OCD
🧠 Essential Tremor
Preclinical data shows normalization of GABAA receptor
activity without disrupting GABA signaling — a mechanism that may sidestep the side effects common in current treatments.
In its Tourette Phase 2 trial, sepranolone demonstrated:
🎯 28% drop in tic severity (p=0.051)
🎯 69% improvement in quality-of-life scores
🎯 No CNS or systemic side effects (2)(5)
Now, Relmada is preparing to launch a Phase 2 trial in Prader-Willi Syndrome in H1 2026 — another high-need market with no effective treatments and a global population of ~400,000. (2)(3)(5)
💯 Cash in the Bank, No Debt, No
Confusion
Small-cap biotechs often carry a red flag: capital overhang. But Relmada’s books say otherwise.
🔋 $20.6 million in cash
🧾 No debt
📊 ~33.2M shares outstanding (as-converted)
That’s an unlevered balance sheet heading into multiple Phase 3 prep milestones. There’s no convertible note drama,
no toxic financing, no looming warrants clogging the story. (2)(3)(5)(6)(7)
It’s simple: they’re funded, focused, and in motion.
And the market isn’t sleeping on it.
With 91% response data, FDA talks just months away, a Phase 3 path lining up, and a second asset moving into a high-need space, Relmada has stacked a string of catalysts rarely seen
this clean in small-cap biotech.
Add the balance sheet clarity — cash on hand, no debt, no overhang — and you start to see why Relmada Therapeutics, Inc. (Nasdaq: RLMD) has already ripped over 420% in the last 6 months as momentum chasers pile in.
For many, it’s less about “if” and more about “how far” this setup can stretch before the crowd fully catches on. (2)(3)(5)(6)(7)
🔎 Final Word: The Setup Speaks for Itself
Relmada is building momentum in a space that’s hungry for innovation. And they’re doing it with: (2)(3)(5)
✅ Validated chemo agents
✅ Breakthrough formulation
✅ Strong data
✅ Clear near-term milestones
✅ A second
asset ready to pivot into clinical use
The crowd hasn’t caught up yet — but that window won’t stay open forever.