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RELMADA THERAPEUTICS, INC. (RLMD)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 delivered materially lower OpEx and a narrower loss as RLMD pivots to two in-licensed assets; R&D fell 74% YoY to $2.8M and G&A declined 9% YoY to $7.4M, driving EPS improvement to $(0.30) from $(0.59) YoY .
  • Clinical catalyst: 6‑month follow-up from the Phase 2 NDV-01 NMIBC study reported 90% CR at 6 months (19/21) and 91% CR at any time (21/23), with no Grade ≥3 TRAEs—strengthening the case for a 2026 registration-track study start .
  • Guidance updates: NDV‑01 Phase 3 timing clarified to 1H 2026 (was late Q4 2025–early 2026); Sepranolone Phase 2 in PWS also targeted for 1H 2026 (previously late Q4 2025–early 2026) .
  • Liquidity: Cash, equivalents and ST investments were $20.6M at 6/30/25; management is prioritizing NDV‑01 and expects spend to ramp with 2026 trial initiations, implying a catalysts-driven financing window ahead .

What Went Well and What Went Wrong

What Went Well

  • NDV‑01 durability and safety: 6‑month data showed 90% CR at 6 months and 91% CR at any time; no Grade ≥3 TRAEs, no treatment discontinuations due to AEs, no progression to muscle-invasive disease or cystectomies .
    • “...six-month follow-up... produced impressive results, with a 91% CR rate at any time... The data... raise our confidence in NDV‑01 as a potential durable treatment...” — Raj S. Pruthi, CMO .
  • Strategic clarity and execution: Team expansion with CMO Oncology and Clinical Advisory Board Chair; program plans, FDA interactions and CMO/CMC scale-up defined into 2H25/1H26 .
  • Financial discipline: R&D down to $2.8M and G&A to $7.4M y/y; net loss narrowed to $9.9M vs $17.8M y/y; cash Op CF improved vs prior-year quarter ($6.4M vs $13.3M) .

What Went Wrong

  • Cash draw and runway: Cash and ST investments fell to $20.6M at quarter end from $44.9M at year-end 2024, reflecting operating cash use; larger studies in 2026 likely require additional capital .
  • Development push/clarification: Both NDV‑01 Phase 3 and sepranolone Phase 2 start shifted/clarified to 1H 2026 vs prior “late Q4 2025–early 2026,” modestly extending the path to value inflections .
  • Estimate visibility: No SPGI consensus available for Q2 revenue/EPS; absence of coverage complicates “beat/miss” framing for near-term trading [GetEstimates]*.

Financial Results

MetricQ2 2024Q1 2025Q2 2025
R&D Expense ($M)$10.72 $12.00 $2.82
G&A Expense ($M)$8.10 $6.30 $7.40
Total Operating Expenses ($M)$18.82 —$10.22
Net Loss ($M)$(17.77) $(17.60) $(9.87)
Diluted EPS ($)$(0.59) $(0.58) $(0.30)
Cash Op CF ($M)$(13.30) (Q2’24) $(18.10) (Q1’25) $(6.40) (Q2’25)
Cash+ST Inv. (period-end, $M)$44.9 (12/31/24) $27.1 (3/31/25) $20.6 (6/30/25)

Notes: “—” = not disclosed in cited sources for that period.

KPIs (Clinical/Operational)

  • NDV‑01 CR (Anytime): 91% (21/23) .
  • NDV‑01 CR at 6 months: 90% (19/21) .
  • Safety: No Grade ≥3 TRAEs; no treatment discontinuations due to AEs .
  • Shares Outstanding: 33,191,622 (as of Aug 4, 2025) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
NDV‑01: FDA interactions & product supply scale-up2H 2025Q2–Q4 2025 2H 2025 Maintained
NDV‑01: Initiate Phase 3 (registration‑track)StartLate Q4 2025–Early 2026 1H 2026 Clarified/shifted later within window
Sepranolone (PWS): Phase 2 initiationStartLate Q4 2025–Early 2026 1H 2026 Clarified/shifted later within window
Financial guidance (rev/margins/OpEx)2025None given None given Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
NDV‑01 efficacy & durabilityAUA topline planned; early 3‑ and 6‑month signals positive 6‑month CR 90%; Anytime CR 91%; safety benign Strengthening
Regulatory path & target populationEngage FDA; consider BCG‑unresponsive, chemoablation, intermediate‑risk routes Management weighing low/intermediate‑risk chemoablation path vs high‑risk; FDA meetings planned Sharpening focus
Competitive landscapeUroGen path/ODAC noted; BRIDGE study context; broad NMIBC field Post‑UroGen approval context discussed; NDV‑01 positioned for ease-of-use and durability Favorable positioning claims
Manufacturing/supply (CMC)Scale-up and dual sourcing anticipated Transfer to CMO; clinical batch scale-up in 2H25 Advancing
R&D spend cadenceQ1: R&D $12M; ramp tied to 2026 trials Q2: R&D $2.8M; spend low pre-enrollment; will rise with trial starts Lower near-term; ramp later

Management Commentary

  • “...six months follow-up from the phase two study... produced impressive response rates, with ninety one percent of patients achieving high grade disease free status at any time point...” — CEO Sergio Traversa .
  • “...NDV‑01... designed to increase exposure to drug and simplify delivery and accessibility, has the potential to significantly change how we manage patients with NMIBC.” — Raj S. Pruthi, MD, CMO (press release) .
  • “We intend to initiate a Phase three study for NDV‑01 in 2026... and initiate the phase two study with sepranolone in Prader‑Willi syndrome also in 2026.” — CEO Sergio Traversa .
  • “R&D expense... decreased... primarily driven by the wind down of REL‑1017 trial costs... offset by ramp up of NDV‑01 and sepranolone activities...” — CFO Maged Shenouda .

Q&A Highlights

  • Regulatory path and study setting: Management is evaluating whether to pursue a UroGen‑like single‑arm chemoablation path in low/intermediate‑risk NMIBC for speed vs high‑risk/BCG‑unresponsive (smaller, slower to enroll) populations; FDA discussion will be decisive .
  • Competitive dynamics: UroGen approval provides precedent; NDV‑01 aims to differentiate via ready‑to‑use intravesical delivery and sustained 10‑day exposure potentially enhancing efficacy and convenience vs hospital‑mixed chemo .
  • R&D expense trajectory: Spend declined due to lack of patient enrollment; expected to increase as Phase 3 NDV‑01 and Phase 2 sepranolone initiate in 1H 2026 .
  • Manufacturing scale-up: Transfer to CMO and scale-up of clinical batches underway; plan for capacity and dual sourcing discussed earlier in the year .
  • Timing of further data: 9‑ and 12‑month follow-ups anticipated to support durability and regulatory interactions .

Estimates Context

  • Wall Street consensus (S&P Global) for Q2 2025 revenue and EPS was not available at the time of this analysis; no beat/miss framing is possible. Results should instead be assessed vs internal OpEx trajectory and clinical milestones [GetEstimates]*.
  • Where one estimate appears (future revenue = $0.0 for Q4 2025; 1 estimate), it is not decision‑useful for the reported quarter and reflects pre‑commercial status [GetEstimates]*.
  • Values retrieved from S&P Global.

Key Takeaways for Investors

  • Strong NDV‑01 6‑month efficacy and clean safety de‑risk the asset and support a 2026 registration‑track study; 9‑ and 12‑month data are near‑term clinical catalysts .
  • FDA path selection (chemoablation in low/intermediate‑risk vs high‑risk) can materially affect time‑to‑approval and market access; watch FDA feedback in 2H 2025 .
  • Cash of $20.6M at 6/30/25 and reduced OpEx buy time into 2026 starts, but larger studies will likely require financing; align position sizing with potential capital needs and timing of data .
  • Competitive backdrop (UroGen approval, TAR‑200, others) is evolving; NDV‑01’s ready‑to‑use, sustained exposure may be an adoption advantage if Phase 3 confirms efficacy .
  • Sepranolone offers a second shot on goal in PWS with a mechanistic rationale from Tourette’s data; Phase 2 initiation in 1H 2026 provides pipeline diversification .
  • Trading setup: Stock likely reacts to (i) FDA feedback on registrational path, (ii) 9/12‑month NDV‑01 durability readouts, and (iii) any financing overhang resolution; near‑term results are driven by clinical news flow rather than fundamentals .
  • Risk balance: Execution/CMC scale‑up, regulatory clarity, and capital raise timing are the main swing factors; clinical signal‑to‑noise remains favorable based on accumulating NDV‑01 data .

Citations:

  • Q2 2025 8‑K and press release, financials, pipeline and NDV‑01 data: .
  • Q2 2025 earnings call transcript (prepared remarks and Q&A): .
  • Prior quarter and earlier disclosures (Q1 2025, Q4 2024): .
  • AUA2025 initial NDV‑01 data (context for trend): .