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RELMADA THERAPEUTICS, INC. (RLMD)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered tighter cost control and a narrower loss: net loss of $18.6M and EPS of -$0.62; R&D fell to $11.0M and G&A to $8.1M, with operating cash burn of $8.8M versus $10.2M in Q4 2023 .
  • EPS beat Street: actual -$0.62 vs consensus -$0.70* (+$0.08, +11.4%); revenue remains $0 in line with consensus $0*; prior quarter Q3 was a miss (actual -$0.72 vs -$0.64*) .
  • Guidance improved: cash and short-term investments of ~$44.9M at 12/31/2024 with runway “into H1 2026,” up from prior “into 2025” (Q2/Q3) .
  • Strategic pivot: in-licensed NDV-01 (HG‑NMIBC) and sepranolone (Tourette/PWS); near-term catalysts include NDV‑01 Phase 2 topline at AUA (Apr 26–29, 2025) and planned FDA interactions; P11 (psilocybin) is being reevaluated due to competitive landscape .

What Went Well and What Went Wrong

What Went Well

  • Cost discipline: R&D down to $11.0M (vs $14.7M YoY) and G&A down to $8.1M (vs $12.1M YoY); EPS improved to -$0.62 from -$0.84 YoY .
  • Strategy/portfolio: acquired rights to NDV‑01 and sepranolone; “transform the Company through strategic product acquisition… exceptional value-creation opportunities” — CEO .
  • Runway uplift: cash/short-term investments ~$44.9M and “adequate… into H1 2026,” providing flexibility to prosecute new programs — CFO .

What Went Wrong

  • Pre‑revenue profile persists; operating loss remains high with net loss of $18.6M in Q4 2024 .
  • Program uncertainty: management is “reevaluating further development of P11” given crowded metabolic space and resource prioritization — CFO .
  • Sequential variability: Q3 EPS missed consensus (-$0.72 vs -$0.64*) before rebounding in Q4; indicates sensitivity to quarterly expense cadence .

Financial Results

Quarterly summary (sequential and YoY)

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$0 $0 $0
R&D Expense ($USD Millions)$10.7 $11.1 $11.0
G&A Expense ($USD Millions)$8.1 $11.9 $8.1
Net Loss ($USD Millions)$17.8 $21.7 $18.6
Diluted EPS ($USD)-$0.59 -$0.72 -$0.62
Operating Cash Used ($USD Millions)$13.3 $16.7 $8.8
Cash & Short-term Investments at Period-end ($USD Millions)$70.4 $54.1 $44.9
Shares Outstanding (Millions)30.174 30.174 30.174

Q4 YoY comparison

MetricQ4 2023Q4 2024
R&D Expense ($USD Millions)$14.7 $11.0
G&A Expense ($USD Millions)$12.1 $8.1
Operating Cash Used ($USD Millions)$10.2 $8.8
Net Loss ($USD Millions)$25.1 $18.6
Diluted EPS ($USD)-$0.84 -$0.62

Results vs Wall Street consensus

MetricQ2 2024Q3 2024Q4 2024
EPS Actual ($USD)-$0.59 -$0.72 -$0.62
EPS Consensus Mean ($USD)-$0.8275*-$0.64*-$0.70*
EPS Surprise ($USD)+$0.2375-$0.08+$0.08
EPS Surprise (%)+28.7%-12.5%+11.4%
Revenue Actual ($USD Millions)$0 $0 $0
Revenue Consensus Mean ($USD Millions)$0.0*$0.0*$0.0*
Primary EPS – # of Estimates4*3*2*

Consensus values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayFunding horizon“into 2025” (Q2/Q3) “into H1 2026” Raised runway
NDV‑01 Phase 2 toplineAUA meetingN/AApr 26–29, 2025 presentation New milestone
NDV‑01 registration‑track study startLate 2025/early 2026N/ALate Q4 2025 to early 2026 New milestone
Sepranolone Phase 2b (Tourette)Late 2025/early 2026N/ALate Q4 2025 to early 2026 New milestone
Sepranolone Phase 2 (PWS)Late 2025/early 2026N/ALate Q4 2025 to early 2026 New milestone
REL‑P11 (psilocybin)Program statusPhase 1 to begin by YE 2024 Reevaluating further development/prioritization Lowered/paused

Earnings Call Themes & Trends

TopicQ2 2024 (prior)Q3 2024 (prior)Q4 2024 (current)Trend
Strategic focusREL‑1017 Phase 3; interim analysis and enrollment by YE 2024 REL‑1017 interim outcome as de‑risking event; confirm futility threshold ~2 points Pivot to in‑licensed NDV‑01 and sepranolone; acquisitions to “transform” the company Shift from MDD to oncology/compulsion assets
Regulatory pathInterim analysis (no alpha penalty) and screen rigor No alpha hit; late interim timing Plan FDA interactions for NDV‑01/sepranolone; explore potential single open‑label registration study for NDV‑01 Active FDA planning
R&D executionTightened criteria; ~80% screen fail as quality filter Expense ramp for studies; disciplined design R&D reduced as legacy trials wound down; focus on new programs Cost base shifting
Cash runwayAdequate into 2025 Adequate into 2025 Adequate into H1 2026 Improved
Product performance outlookREL‑P11 Phase 1 initiation planned Phase 1 screening “very soon” P11 reevaluation due to market competition/regulatory caution De‑prioritized

Management Commentary

  • “We initiated a process to transform the Company through the exploration of strategic product acquisition… with the recent acquisition of two high‑potential Phase 2 programs NDV‑01 and sepranolone.” — CEO .
  • “With a $44.8 million cash balance… and clean balance sheet, we begin the year with solid financial strength.” — CFO .
  • “Top line safety and efficacy data for NDV‑01 [Phase 2] expected at AUA… April 26–29, 2025… next step is a registrational trial.” — CEO .
  • “We are reevaluating further development of P11… given our emphasis on focused patient populations, and the increasingly competitive clinical development landscape in metabolic disease.” — CFO .

Q&A Highlights

  • NDV‑01 in‑licensing: competition existed; Relmada cited strong development capability, focused portfolio, and partner alignment (Trigone shareholders now RLMD shareholders) .
  • NDV‑01 data expectations: abstracts won’t include data; complete response “rule of thumb” competitive at ~75% at month 3–4 per urologist feedback; company will present at AUA .
  • Sepranolone safety: >350 subjects; main AEs were mild injection site reactions; management sees complementary role in PWS alongside other agents .
  • Endpoints: Tourette likely YGTSS with compulsivity components; PWS endpoints inferred from recent approval paradigms; formal FDA discussions pending .
  • Regulatory pathway: potential for single open‑label registration study for NDV‑01 based on precedent and gem/doce experience; will confirm with FDA .

Estimates Context

  • Q4 EPS beat: -$0.62 vs -$0.70*; Q3 miss: -$0.72 vs -$0.64*; Q2 beat: -$0.59 vs -$0.8275*; revenue consensus was $0* and actual $0 across periods .
  • With cost reductions as legacy trials wind down and new programs beginning pre‑FDA interactions, near‑term EPS estimates may reflect lower OpEx in Q4 but could drift upward as NDV‑01/sepranolone enter Phase 2/registration activities; management will update spend/cash runway after FDA meetings .

Consensus values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • EPS beat in Q4 driven by lower R&D and G&A and reduced operating cash burn; the company remains pre‑revenue but is demonstrating expense control .
  • Strategic repositioning adds potential nearer‑term catalysts (NDV‑01 Phase 2 topline at AUA; FDA path discussions; sepranolone Phase 2b/2 starts late 2025/early 2026) that can reframe the narrative beyond MDD .
  • Runway extended to H1 2026, reducing financing overhang in the near term; watch for spend updates post‑FDA meetings that could recalibrate burn .
  • P11 reevaluation removes a near‑term cash drain in a crowded category; focus consolidates on oncology and neuro‑compulsion programs .
  • Q2–Q4 estimate dynamics show volatility tied to spend; traders should watch upcoming AUA data and any FDA feedback as principal stock‑moving events .
  • Regulatory pathway clarity (e.g., single‑study registration track for NDV‑01) would be a material derisking milestone and potential rerating catalyst .
  • Maintain awareness of execution risk as new programs scale; monitor operating discipline and partnership structure (e.g., Trigone shareholder alignment) as supports .