Executive Summary

Q4 FY2025 delivered continued clinical execution and balance sheet strength: cash, cash equivalents and marketable securities totaled $167.9M as of June 30, 2025 (vs. $127.1M a year ago), supporting commercialization preparations .
The company completed and exceeded sunRIZE Phase 3 enrollment (62 participants) with topline data expected in December 2025; baseline demographics confirm severe disease burden and comparability to Phase 2 RIZE .
FDA aligned on a streamlined Phase 3 upLIFT design in tumor HI, truncating to a single‑arm open‑label study (~16 patients), with topline results expected in 2H 2026, de‑risking the pathway .
EPS of $(0.26) missed Wall Street consensus of $(0.22), driven by higher R&D (clinical trial activity, manufacturing, personnel) and elevated G&A (professional fees, headcount), while revenue remained $0.00 (as expected) .
Near‑term stock catalyst is the December sunRIZE topline readout; medium‑term catalysts include BLA filing (target mid‑2026) and upLIFT readouts, per management commentary at Morgan Stanley’s conference .

What Went Well and What Went Wrong

What Went Well

Completed sunRIZE enrollment (62 participants) and maintained December 2025 topline timing, reinforcing clinical execution in congenital HI .
FDA alignment to streamline upLIFT to a single‑arm open‑label Phase 3 (~16 participants) indicates regulator support and real‑world efficacy signals; topline remains targeted for 2H 2026 .
Strengthened commercialization capabilities by appointing Chief Commercial Officer Dr. Sunil Karnawat; management emphasized confidence in rare disease pricing and US self‑commercialization .
Quote: “We have made substantial progress this year across our two indications... We remain on track to report topline results from the sunRIZE trial in December” — Nevan Elam, CEO .

What Went Wrong

EPS of $(0.26) missed consensus of $(0.22)* as operating expenses rose (R&D $20.9M; G&A $5.0M), reflecting clinical progression and organizational build‑out .
Net loss widened to $(24.4)M vs $(23.0)M YoY for Q4 FY2025, underscoring increased clinical/manufacturing and personnel costs .
No revenue reported (development stage); while in line with expectations*, it limits traditional margin analysis and puts focus on cash runway and trial timelines .

Financial Results

Income Statement Summary (in $USD Thousands)

Metric	Q2 2025	Q3 2025	Q4 2025
Research and development	$12,627	$15,283	$20,863
General and administrative	$4,453	$4,740	$4,987
Total operating expenses	$17,080	$20,023	$25,850
Loss from operations	$(17,080)	$(20,023)	$(25,850)
Non-operating income (expense), net	$1,350	$1,109	$1,460
Net loss	$(15,730)	$(18,914)	$(24,390)
Diluted EPS	$(0.22)	$(0.27)	$(0.26)
Shares used (diluted)	69,940	70,031	94,340

Notes:

Revenue: $0.00 across periods (development stage)*.
Margin analysis not meaningful due to zero revenue.

Balance Sheet Snapshot (in $USD Thousands)

Metric	Q2 2025 (Dec 31, 2024)	Q3 2025 (Mar 31, 2025)	Q4 2025 (Jun 30, 2025)
Cash and cash equivalents	$8,932	$14,596	$94,107
Investments in marketable debt securities	$96,383	$73,810	$73,751
Working capital	$88,086	$78,208	$159,233
Total assets	$112,007	$94,739	$175,490
Accumulated deficit	$(360,552)	$(379,466)	$(403,856)
Total stockholders’ equity	$99,589	$82,569	$162,127

Drivers:

April 2025 equity financing of ~$97M extended runway to mid‑2027 and contributed to Q4 cash/investment levels .

Estimates vs Actuals (Quarterly)

Metric	Q4 2025 Consensus	Q4 2025 Actual	Surprise
EPS ($)	$(0.22)*	$(0.26)	-$0.04 (miss)*
Revenue ($)	$0.00*	$0.00*	In‑line*

Values retrieved from S&P Global.*

Segment Breakdown

Not applicable; Rezolute did not report revenue segments or product sales in Q4 FY2025 .

Clinical KPIs (sunRIZE, Congenital HI)

KPI	Value
Enrollment completed	62 participants
Topline timing	December 2025
Avg age	3.4 years
% <2 years	35%
Hypoglycemia events/week	15
Daily % time in hypoglycemia	19%
On ≥1 SOC treatment	95%

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
sunRIZE topline (Congenital HI)	Q4 2025	“Topline results expected in Dec 2025” (Q3 FY2025)	“Topline results expected in Dec 2025; enrollment completed (62)”	Maintained timing; execution advanced (completed enrollment)
sunRIZE enrollment	Q2–Q4 2025	“Enrollment expected to conclude May 2025” (Q3)	“Enrollment completed; exceeded target (62)” (Q4)	Raised (exceeded target)
upLIFT design (Tumor HI)	2025–2026	“Registrational study to begin mid‑2025; topline 2H 2026” (Q3)	“FDA alignment to truncate to single‑arm OL (~16 pts); topline 2H 2026”	Streamlined design; timing maintained
Cash runway	2025–2027	“Runway extended to mid‑2027” (Q3)	Not updated in Q4 PR; cash/investments $167.9M at 6/30/25	Maintained (implied support by balance sheet)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 & Q3)	Current Period (Q4 FY2025)	Trend
Regulatory designations & alignment	BTD granted for congenital HI (Q2) ; BTD granted for tumor HI (Q3)	FDA alignment to streamline upLIFT single‑arm OL (~16 pts)	Acceleration/derisking
R&D execution (sunRIZE)	Infant OL DMC review; US sites activated; enrollment expected by May 2025	Enrollment completed/exceeded; baseline severity characterized; topline Dec 2025	Strong execution
Commercial readiness	Added rare disease commercial leader to Board (Erik Harris)	Appointed CCO (Dr. Sunil Karnawat); plan for US self‑commercialization	Build‑out progressing
Capital & runway	~$97M financing in April; runway to mid‑2027	Cash/investments $167.9M at Q4 end	Balance sheet strengthened
Tumor HI program	Orphan Drug Designation; registrational upLIFT planned H1/Mid‑2025; topline 2H 2026	UpLIFT study truncated to OL; topline 2H 2026	Streamlined path

Note: No formal Q4 earnings call transcript was available in the repository; management commentary leveraged from the Q4 press release and the Morgan Stanley conference transcript –.

Management Commentary

“We have made substantial progress this year across our two indications for ersodetug... We remain on track to report topline results from the sunRIZE trial in December and look forward to progressing towards potential commercialization.” — Nevan Charles Elam, CEO .
On FDA alignment and upLIFT: “We believe it’s a pretty significant development... [FDA aligned] that we don’t need a placebo controlled study... particularly in rare diseases” — Morgan Stanley conference .
On regulatory timeline: “We would expect to file our BLA mid‑2026... PDUFA date in early 2027” — Morgan Stanley conference .
On commercial strategy and pricing: “We are in a sweet spot in metabolic disease with pediatric rare disease pricing... US self‑commercialization” — Morgan Stanley conference .

Q&A Highlights

FDA alignment on upLIFT: Management detailed the shift to a ~16‑patient single‑arm OL Phase 3 based on real‑world efficacy in severely compromised tumor HI patients, removing need for placebo control .
December sunRIZE readout: Success defined by clinically meaningful reductions in hypoglycemia vs placebo (targeting ~35% difference between arms), with baseline severity underscored by ~20% time in hypoglycemia and ~15 events/week .
Commercial approach: US self‑commercialization with rare disease pricing and weight‑based dosing; ex‑US strategy to balance distribution/partnering across regions like Europe and the Middle East .
Regulatory timeline: BLA filing targeted mid‑2026 with PDUFA in early 2027; tumor HI as a fast follower depending on Phase 3 progress .
Competitive landscape: Company sees complementary therapies (somatostatin analogs, glucagon) but views ersodetug as uniquely universal and durable across all forms of HI .

Estimates Context

EPS missed consensus: $(0.26) actual vs $(0.22) consensus*; ~-$0.04 delta likely driven by higher R&D ($20.9M) and G&A ($5.0M) as trials advanced and headcount/professional fees rose .
Revenue in‑line: Consensus $0.00* vs actual $0.00*; as a development‑stage biotech, revenue is not yet a driver.
Coverage depth: EPS estimates (10), revenue estimates (10)*.