Executive Summary

Q3 2025 focused on pipeline execution and capital strength: Relmada reported lower operating expenses and net loss year over year, secured FDA alignment on two registrational paths for NDV-01 in NMIBC, and completed a $100M financing, extending cash runway into 2028 .
Clinical data strengthened: NDV-01 showed 92% complete response at any time, 85% CR at nine months, and no ≥ Grade 3 TRAEs; subpopulation BCG‑unresponsive achieved 91% CR “any time” and 88% at nine months—supporting a potential best‑in‑class profile and rapid approval path in refractory settings .
Operating discipline continues: R&D fell to $4.04M (from $11.15M YoY) and G&A to $6.29M (from $11.86M YoY); net loss narrowed to $10.09M ($0.30/share) from $21.73M ($0.72/share) in Q3 2024 .
Stock reaction catalysts ahead: FDA-aligned Phase 3 initiations for two NDV‑01 indications and Sepranolone PWS Phase 2 in 1H 2026; 12‑month NDV‑01 data expected Q1 2026—each a potential inflection point .

What Went Well and What Went Wrong

What Went Well

NDV‑01 efficacy and safety: 92% CR “any time,” 85% CR at nine months; no progression to muscle-invasive disease, no cystectomies, and no ≥ Grade 3 TRAEs—“Positive 9-month data… reinforce our confidence in NDV‑01’s potential” (CEO) .
Regulatory alignment: FDA indicated a single‑arm registrational study may be acceptable for high‑risk second‑line BCG‑unresponsive patients; randomized adjuvant study post‑TURBT acceptable for intermediate‑risk; no additional non‑clinical studies required for 505(b)(2) NDA—“key de‑risking milestone” (CMO) .
Capital runway: Completed $100M financing (≈$94M net), extending runway into 2028—“well capitalized… resources to support planned operations into 2028” (CFO, CEO) .

What Went Wrong

Pre‑revenue profile persists; estimates unavailable: No revenue line items disclosed; Wall Street consensus EPS/revenue for Q3 2025 unavailable via S&P Global* .
Cash and investments down sequentially prior to financing: Cash, equivalents & short‑term investments fell to $13.9M at 9/30/25 from $20.6M at 6/30/25 (before net offering proceeds), highlighting need for external capital ahead of Phase 3 scale‑up .
Dilution risk and share count dynamics: Shares outstanding reported at 73,333,622 (as of Nov 10, 2025), implying potential dilution vs 33.19M weighted average shares; necessary for runway but a valuation headwind .

Financial Results

Income Statement Snapshot (USD Millions; EPS in USD)

Metric	Q3 2024	Q2 2025	Q3 2025
Research & Development ($MM)	$11.15	$2.82	$4.04
General & Administrative ($MM)	$11.86	$7.40	$6.29
Total Operating Expenses ($MM)	$23.01	$10.22	$10.33
Net Loss ($MM)	$(21.73)	$(9.87)	$(10.09)
Diluted EPS ($)	$(0.72)	$(0.30)	$(0.30)
Weighted Avg Shares (MM)	30.17	33.19	33.19

Balance Sheet and Liquidity

Metric	Q4 2024	Q2 2025	Q3 2025
Cash + Short‑Term Investments ($MM)	$44.91	$20.60	$13.89 (excl. ≈$94M net offering proceeds)
Shares Outstanding (MM)	30.17	33.19	73.33 (as of Nov 10, 2025)

Notes: Q3 2025 cash excludes ≈$94M net proceeds from the $100M offering closed Nov 5, 2025 .

KPIs – NDV‑01 Clinical Efficacy and Safety

KPI	Value
CR “any time”	92% (23/25)
CR at 3 months	84% (21/25)
CR at 6 months	87% (20/23)*
CR at 9 months	85% (17/20)*
BCG‑Unresponsive CR “any time”	91% (10/11)
BCG‑Unresponsive CR at 9 months	88% (7/8)
Safety signals	No ≥ Grade 3 TRAEs; no discontinuations due to AEs
Progression/cystectomy	None observed (no progression to muscle‑invasive; no cystectomy)

*Includes patients with CR after re‑induction; 60% CR rate after re‑induction .

Segment Breakdown

Not applicable; company is pre‑commercial and reports consolidated operating expenses .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Company horizon	Adequate through key milestones into H1 2026	Sufficient to support planned expenses into 2028 (post‑offering)	Raised
NDV‑01 Phase 3 – High‑risk BCG‑Unresponsive	Start	H1 2026 planned initiations noted in prior updates	H1 2026 initiation; single‑arm may be acceptable per FDA	Maintained, path clarified
NDV‑01 Phase 3 – Intermediate‑risk Adjuvant	Start	H1 2026 planned initiations noted in prior updates	H1 2026 initiation; randomized post‑TURBT vs observation acceptable to FDA	Maintained, path clarified
NDV‑01 12‑month Phase 2 data	Timing	Q1 2026 planned	Q1 2026 reaffirmed	Maintained
Sepranolone (PWS) Phase 2	Start	H1 2026 planned	H1 2026 reaffirmed	Maintained

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 2025)	Previous Mentions (Q2 2025)	Current Period (Q3 2025)	Trend
NDV‑01 efficacy	AUA topline: 90% ORR “any time”; 100% DF at 6 months among 7 evaluable	91% CR “any time”; 90% at 6 months; favorable safety	92% CR “any time”; 85% at 9 months; no progression/cystectomy; strong safety	Improving durability; consistent safety
FDA path	Seeking FDA to discuss registrational strategy; outline possible routes (chemoablation; randomized intermediate‑risk)	Preparations for FDA interactions	FDA alignment: single‑arm in high‑risk; randomized adjuvant in intermediate‑risk; no new non‑clinical	De‑risked, clearer path
Manufacturing/supply chain	Plan to scale up and add second manufacturer; not complex gel‑based product	Transfer to CMOs and scale‑up planned	Production transfer and clinical batch scale‑up ongoing	Advancing readiness
Financing / runway	~$27.1M cash at 3/31; disciplined spend	$20.6M cash at 6/30; clean balance sheet	$100M offering closed; runway into 2028	Strengthened capital
OpEx discipline	R&D down post REL‑1017 wind‑down	R&D down to $2.8M; G&A $7.4M	R&D $4.0M; G&A $6.3M; net loss narrower YoY	Sustained cost control
Pricing/competitive context	Not detailed	Strategy discussion vs UroGen/BCG; FDA pathways	Pricing comps: INLEXZO ~$69k/dose; first‑year near ~~$700k; expected NDV‑01 pricing somewhere between ZUSDURI (~~$120k) and INLEXZO; will be data‑driven (management)	Market pricing benchmark forming

Management Commentary

CEO: “Positive 9‑month data… and the positive outcome of our Type B meeting with the FDA further reinforce our confidence in NDV‑01’s potential to become a best‑in‑class treatment for NMIBC… The recent $100M underwritten financing provides the resources to drive forward the planned registrational studies for NDV‑01” .
CMO (Oncology): “Securing FDA alignment for two distinct registrational paths provides a clear path to advance NDV‑01… We believe a single‑arm registrational study in high‑risk, refractory BCG‑unresponsive patients offers a rapid route to potential approval” .
CFO: “Based on current plans, the company believes that its current cash balance, including net proceeds from the offering, is sufficient to support planned expenses into 2028” .

Q&A Highlights

Indication strategy and market sizing: High‑risk BCG‑unresponsive (~8k/year) versus intermediate‑risk (~80k incident/prevalent/year; ~40k receive adjuvant therapy); plan to initiate both trials around Q2 2026 for operational efficiency .
Trial timelines: High‑risk single‑arm: first patient Q2 2026; 3‑month data by Q4 2026; primary endpoint 12‑month CR in Q2 2027; topline Q2 2028. Intermediate‑risk adjuvant: enroll ~15 months; 18–24 months follow‑up; interim at 70% events .
Pricing landscape: Reference to J&J INLEXZO ~$69k/dose with total first‑year ~ $700k, ZUSDURI ~ $120k/year; Relmada will be data‑driven and assess market reception to competitor pricing before setting NDV‑01 price .
Differentiation and access: NDV‑01’s ready‑to‑use, in‑office 5‑minute intravesical instillation avoids specialized pharmacy and prolonged chair time—potentially expanding use in community urology (70–80% of care) versus conventional gem/doce hurdles .
BRIDGE trial implications: If Gem/Doce proves non‑inferior to BCG (n≈800; readout ~2 years), NDV‑01’s ease of use and sustained release could unlock off‑label uptake and broaden adoption .

Estimates Context

Q3 2025 Wall Street consensus EPS and revenue estimates via S&P Global were unavailable for RLMD’s quarter; Relmada is pre‑commercial and did not report revenue. As a result, no beat/miss analysis versus estimates can be provided for EPS or revenue.*
Target Price Consensus Mean data retrieved for “Q3 2025” was not applicable to quarterly comparisons and is not used in this recap.*

*Values retrieved from S&P Global.

Key Takeaways for Investors

NDV‑01 is building a high‑confidence efficacy and safety profile with 9‑month durability, and now has FDA‑aligned, two‑path registrational strategy—positioning for potential expedited approval in refractory BCG‑unresponsive patients .
Capital risk materially reduced: $100M raise extends runway into 2028, enabling parallel Phase 3 starts for two indications and PWS Phase 2—all likely news catalysts through 2026–2028 .
Operational leverage: Sustained cost discipline with YoY OpEx reductions and narrower net loss supports a cleaner setup ahead of trial scale‑up; watch for expense re‑acceleration as enrollment begins .
Market access differentiation: NDV‑01’s ready‑to‑use format addresses community‑care bottlenecks for conventional gem/doce, a key commercial advantage vs competitors requiring complex administration .
Pricing dynamics: Management indicates pricing will be data‑driven; competitor benchmarks range broadly ($120k–$700k/year). Adoption will hinge on clinical value, ease of use, and payer reception .
Near‑term catalysts: 12‑month Phase 2 NDV‑01 data (Q1 2026), IND clearance and Phase 3 initiations (H1 2026), interim updates, and Sepranolone PWS Phase 2 start—each with potential to re‑rate the stock .
Risk monitor: Execution on manufacturing scale‑up, regulatory interactions, enrollment pace (especially in BCG‑unresponsive CIS), and capital deployment discipline remain critical; dilution already evident in share count metrics .

RELMADA THERAPEUTICS, INC. (RLMD)·Q3 2025 Earnings Summary