SPONSORED BY SICA MEDIA AND DISSEMINATED ON BEHALF OF RELMADA THERAPEUTICS, INC.*

Good Morning Market Enthusiast,

There’s a quiet shift underway in cancer care — and it’s being led by a name most of Wall Street hasn’t caught up to yet.

Relmada Therapeutics, Inc. (Nasdaq: RLMD) just delivered Phase 2 efficacy data in a major bladder cancer indication that’s hard to ignore:

👏 91% complete response at any timepoint.
💪 0% progression to invasive disease.
🧪 And all without triggering a single Grade 3 adverse event. (2)(3)(5)

(1)

Relmada didn’t stumble into these numbers. This is the result of a clever formulation strategy using existing chemo agents in a brand-new delivery platform — one that keeps the drugs in place for over 10 days and avoids the systemic toxicity other therapies can’t escape.(2)(5)

Now the roadmap is clear:

Q4 2025 → FDA interactions and additional data. 
H1 2026 → Phase 3 initiation. (2)(3)(5)

And with a debt-free balance sheet and $21 million in cash, Relmada isn’t limping toward the finish line — it’s sprinting. (2)(5)(6)(7)

Let’s break down why this setup has biotech watchers circling back, and why the next 6 months could reshape everything for this small-cap name.

(2)

🧬 The Backdrop: A $4.5B Bladder Cancer Market Desperate for Innovation

Bladder cancer is the 6th most common cancer in the U.S., and non-muscle invasive bladder cancer (NMIBC) makes up the bulk of those cases.

⚠️ 600,000 people in the U.S. are currently living with NMIBC.
📊 Up to 68,000 new patients are diagnosed each year.
🔁 And here’s the kicker: up to 80% will experience recurrence. (2)(5)

The current frontline therapy, BCG, has major issues:

🚫 Repeated supply shortages
🚫 Complex handling
🚫 Immune-related side effects
🚫 Limited efficacy in high-risk groups

Urologists need better tools. And they’ve been waiting for years. (2)(5)

Relmada’s solution? NDV-01 — a sustained-release, intravesical chemo formulation that delivers gemcitabine and docetaxel (Gem/Doce) directly to the bladder wall with 10 days of exposure, followed by safe excretion. (2)(5)

It’s a differentiated in-situ drug reservoir — no complicated devices, no systemic side effects, and no need for a hospital stay.

💡 Why NDV-01 Is Turning Heads

Relmada didn’t invent Gem/Doce. What they did was smarter.

They built NDV-01 to take a proven combo — one already used off-label by top urologists — and dramatically improve how it’s delivered.  (2)(3)

The result?

✅ 91% complete response rate (CRR) across all time points
✅ No Grade 3+ adverse events
✅ No patient progression to muscle-invasive disease
✅ No radical cystectomies required
✅ Zero treatment discontinuations (2)(3)(5)

That’s not a fluke — it’s a fundamental improvement.

(2)

And the urologic community is noticing. 

In recent coverage, Gem/Doce has been highlighted as a leading post-BCG therapy under active evaluation — far ahead of more complex or immune-based therapies.

Relmada’s NDV-01 offers all the efficacy with none of the complications:  (2)(3)(5)

🧪 Prefilled syringe
🧘 In-office procedure in under 10 minutes
🩺 No surgical removal
🚽 Safely excreted via urine

Put simply: NDV-01 is designed for adoption.
 

(2)

🗓️ What’s Coming Next — And Why the Timeline Matters

Relmada has clarity on its path forward — and it’s not vague:

🧪 Q4 2025:

→ Full 9-month Phase 2 data
→ Manufacturing scale-up begins

📅 Q1 2026:

→ 12-month data release

📞 H1 2026:

→ Begin FDA engagement
→ Kick off Phase 3 registration-track study

(2)

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.

To your success,

Max Masters

Co-founder, Market Tips Newsletter

Sources:

1. https://bit.ly/46vZhhw
2. https://d1io3yog0oux5.cloudfront.net/_c0429eff616d9cb234d0b657fddd5aa7/relmada/db/306/3197/pdf/Relmada+IR+Deck+09092025.pdf
3. https://finance.yahoo.com/news/relmada-issues-mid-ceo-letter-111500786.html
4. https://finance.yahoo.com/news/exclusive-relmada-ceo-says-recent-201037784.html
5. https://finance.yahoo.com/news/relmada-therapeutics-inc-rlmd-reports-075302143.html
6. https://finance.yahoo.com/quote/RLMD/
7. https://finance.yahoo.com/quote/RLMD/history/

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