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Rezolute, Inc. (RZLT)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 FY2025 GAAP EPS of $(0.27) missed S&P Global consensus of $(0.23)* by ~$0.04, driven by higher R&D and G&A as Phase 3 programs advanced .
  • sunRIZE Phase 3 (congenital HI) interim analysis concluded with DMC recommending continuation as planned (no sample size increase); enrollment expected to complete in May 2025 with topline in December 2025, a key late-2025 catalyst .
  • FDA granted Breakthrough Therapy Designation to ersodetug for tumor HI; registrational upLIFT study to begin mid-2025 with topline in 2H 2026, expanding the potential label and de-risking development .
  • Cash, cash equivalents and investments were $88.4M at 3/31/25; subsequent ~$97M equity financing closed in April extends runway to mid-2027, supporting execution through pivotal readouts .

What Went Well and What Went Wrong

What Went Well

  • DMC interim analysis for sunRIZE recommended continuation without sample size increase, supporting statistical powering and program momentum toward December 2025 topline .
  • Dual BTDs (congenital and tumor HI) strengthen regulatory dialogue and potential expedited pathways; management emphasized readiness to initiate tumor HI registrational upLIFT mid-2025 .
  • Strengthened balance sheet: ~$97M gross (≈$96.9M net) raised post-quarter; management indicates runway to mid-2027, funding pivotal data and pre-commercial build .
    • “The Phase 3 sunRIZE study…is on track to complete enrollment this month and we are poised to start our registrational upLIFT study for tumor HI mid-year.” — CEO Nevan Charles Elam .

What Went Wrong

  • EPS missed consensus due to increased clinical trial, manufacturing and personnel costs as programs advanced: R&D $15.28M (Q3) vs $12.40M YoY; G&A $4.74M vs $3.81M YoY .
  • Sequential cash/investments drawdown ahead of the April raise: $105.3M (12/31/24) to $88.4M (3/31/25), reflecting spend cadence into pivotal studies .
  • Continued operating losses with rising OpEx: total OpEx $20.02M vs $17.08M QoQ and $16.21M YoY; net loss $(18.91)M vs $(15.73)M QoQ and $(17.05)M YoY .

Financial Results

Quarterly P&L and Balance Sheet (USD Millions, except per-share; fiscal quarters)

MetricQ1 FY2025 (Sep 2024)Q2 FY2025 (Dec 2024)Q3 FY2025 (Mar 2025)
Research & Development$12.75 $12.63 $15.28
General & Administrative$4.19 $4.45 $4.74
Total Operating Expenses$16.94 $17.08 $20.02
Non-operating income (expense), net$1.56 $1.35 $1.11
Net Loss$(15.38) $(15.73) $(18.91)
GAAP EPS (Basic & Diluted)$(0.22) $(0.22) $(0.27)
Weighted Avg Shares (M)69.74 69.94 70.03
Cash & Cash Equivalents (end)$10.47 $8.93 $14.60
Investments (end)$107.35 $96.38 $73.81
Working Capital (end)$102.19 $88.09 $78.21
Total Assets (end)$123.41 $112.01 $94.74
Total Stockholders’ Equity (end)$113.44 $99.59 $82.57

Year-over-Year (Q3 FY2025 vs Q3 FY2024)

MetricQ3 FY2024Q3 FY2025
Research & Development ($M)$12.40 $15.28
General & Administrative ($M)$3.81 $4.74
Total Operating Expenses ($M)$16.21 $20.02
Non-operating income (expense), net ($M)$(0.84) $1.11
Net Loss ($M)$(17.05) $(18.91)
GAAP EPS ($)$(0.34) $(0.27)

EPS vs S&P Global Consensus

PeriodConsensus EPS ($)Actual EPS ($)Beat/Miss
Q1 FY2025$(0.35)*$(0.22) +$0.13 (Beat)
Q2 FY2025$(0.25)*$(0.22) +$0.03 (Beat)
Q3 FY2025$(0.23)*$(0.27) −$0.04 (Miss)

Note: Asterisks indicate values retrieved from S&P Global.

KPIs (Clinical/Corporate)

KPIQ1 FY2025Q2 FY2025Q3 FY2025
sunRIZE (congenital HI) statusEx‑US enrollment on track; US start early 2025 US participants anticipated in Q2’25; interim analysis planned DMC recommended continue as planned, no sample size increase; US sites activated; enrollment to complete May’25; topline Dec’25
Tumor HI programStudy start-up activities progressing; enrollment 1H’25 Registrational study anticipated 1H’25; topline 2H’26 BTD granted; upLIFT to begin mid‑2025; topline 2H’26
Regulatory designations—BTD (congenital HI) BTD (tumor HI)
Cash + Investments (end)$117.8M (Q1 PR) $105.3M $88.4M
Post‑quarter financing——~$97M equity financing closed; runway to mid‑2027

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
sunRIZE enrollment completionFY2025“Overall study enrollment expected to conclude in Q2’25, subject to IA” “Enrollment expected to be completed in May 2025” Maintained/refined (timing specified)
sunRIZE toplineFY2025“Topline expected in Q4’25, subject to IA” “Topline results expected in December 2025” Maintained/refined (month specified)
sunRIZE interim analysisQ2–Q3 FY2025IA planned with possible outcomes incl. sample size +33% DMC: continue as planned; no sample size increase Positive de‑risking
Tumor HI upLIFT startFY2025Start in 1H’25 Start mid‑2025 Maintained
Tumor HI toplineFY20262H’26 2H’26 Maintained
Cash runwayMulti‑yearNot specifiedExtended to mid‑2027 post‑raise New / Positive
Quantitative financial guidanceFY2025None providedNone providedUnchanged

Earnings Call Themes & Trends

Note: We did not find a Q3 FY2025 earnings call transcript on Rezolute’s IR site; the Q3 press release and 10‑Q were posted without a transcript link .

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Regulatory momentumBTD granted for congenital HI (Q2) BTD granted for tumor HI (Q3) Strengthening
Clinical execution (sunRIZE)Ex‑US enrollment on track; US start early 2025 (Q1). US enrollment expected Q2’25 (Q2) DMC IA → continue as planned; US sites activated; enrollment complete May’25; topline Dec’25 On‑track, de‑risked
Tumor HI programRegistrational study start 1H’25; topline 2H’26 upLIFT to begin mid‑2025; topline 2H’26 On‑track
Real‑world/EAP evidenceLimited prior mentionTumor HI EAP cited in BTD rationale More emphasis
Capital & runwayNot highlighted~$97M raise; runway to mid‑2027 Improved funding
Commercial preparation—Appointment of rare disease commercial leader Erik Harris to Board Building capabilities

Management Commentary

  • “The Phase 3 sunRIZE study in congenital HI is on track to complete enrollment this month and we are poised to start our registrational upLIFT study for tumor HI mid-year.” — Nevan Charles Elam, CEO .
  • “Each of our programs received Breakthrough Therapy Designation from FDA this year. We look forward to continued discussions with the agency…” — Nevan Charles Elam, CEO .
  • On tumor HI BTD: “This designation highlights FDA’s recognition of ersodetug’s potential therapeutic benefit…particularly when [hypoglycemia] is refractory or an impediment to surgery or other tumor-directed therapies.” — Nevan Charles Elam, CEO .

Q&A Highlights

  • We did not locate an earnings call transcript for Q3 FY2025 on the company’s IR site; no Q&A excerpts available .

Estimates Context

  • Q3 FY2025: GAAP EPS $(0.27) vs S&P Global consensus $(0.23)* → miss of ~$0.04; primary driver was higher R&D and G&A associated with clinical trial activities, manufacturing and personnel costs .
  • Prior quarters: Q1 and Q2 were modest beats vs S&P Global consensus as reported (see table above); consistent with expense phasing ahead of pivotal milestones .
  • Revenue: Consensus $0 for Q1–Q3 FY2025*, consistent with pre‑commercial stage; company does not report product revenue .

Values with asterisks retrieved from S&P Global.

Key Takeaways for Investors

  • Near‑term catalyst path is clear: sunRIZE enrollment completion (May 2025) and topline in December 2025; outcome is likely the primary stock driver into year‑end .
  • DMC IA “continue as planned” removes risk of a sample size increase and supports confidence in statistical powering for sunRIZE .
  • Expansion to tumor HI with BTD and a mid‑2025 registrational start broadens the addressable population and creates a second pivotal data point in 2H 2026 .
  • Post‑quarter financing extends runway to mid‑2027, reducing financing overhang through pivotal readouts and early launch prep .
  • The Q3 EPS miss reflects intentional investment in pivotal programs; expense intensity likely persists near‑term as trials complete and tumor HI study initiates .
  • Lack of revenue near‑term keeps valuation tied to clinical/regulatory inflections; monitor December 2025 topline, FDA interactions leveraging BTD, and upLIFT enrollment cadence .

Sources

  • Q3 FY2025 8‑K and press release (Ex. 99.1), including condensed financials and business update .
  • Q3 FY2025 press release on IR site .
  • Q2 FY2025 8‑K and press release (Ex. 99.1) .
  • Q1 FY2025 8‑K and press release (Ex. 99.1) .
  • Tumor HI Breakthrough Therapy Designation press release (May 5, 2025) .
  • April 2025 equity financing pricing and closing press releases .
  • Board appointment (Erik Harris) press release .

S&P Global consensus figures marked with an asterisk.