Rezolute, Inc. (RZLT)·Q1 2026 Earnings Summary

Executive Summary

• Q1 FY2026 net loss was $18.2M (EPS $(0.18)), a beat vs S&P Global consensus EPS $(0.261), as operating expenses declined sequentially from Q4; the company remains pre-revenue . Values retrieved from S&P Global
• Cash, cash equivalents and marketable securities were $152.2M at 9/30/25 vs $167.9M at 6/30/25; management reiterated timing catalysts: sunRIZE Phase 3 topline in December 2025 and tumor HI Phase 3 (upLIFT) topline in 2H 2026 .
• FDA alignment allows a streamlined single‑arm Phase 3 for tumor HI (up to 16 patients), reducing development risk and time; enrollment is underway .
• Company hosted a virtual Investor Event on 11/10/25 to discuss commercialization plans for ersodetug in congenital and tumor HI—near-term stock catalyst remains December sunRIZE topline readout .

What Went Well and What Went Wrong

What Went Well

• Maintained December 2025 timing for the registrational sunRIZE Phase 3 topline, reinforcing near-term de‑risking potential: “We remain on track to report topline results from the Phase 3 sunRIZE trial in congenital hyperinsulinism in December.”
• FDA alignment on a truncated, single‑arm Phase 3 for tumor HI (upLIFT) with topline in 2H 2026, eliminating need for a randomized controlled trial and potentially accelerating time to BLA .
• Sequential OpEx improvement: total operating expenses fell to $19.8M from $25.9M in Q4, helping deliver an EPS beat vs consensus despite higher YoY G&A as the company scales for potential commercialization . Values retrieved from S&P Global*

What Went Wrong

• YoY operating expense growth: G&A rose to $6.7M from $4.2M YoY, primarily due to professional fees and headcount; net loss increased to $18.2M from $15.4M YoY .
• Cash and investments declined to $152.2M from $167.9M sequentially, reflecting continued R&D and commercialization build-out ahead of pivotal milestones .
• No product revenue; company remains dependent on financing market conditions and milestone execution; revenue consensus remained $0 for recent quarters* . Values retrieved from S&P Global*

Financial Results

P&L summary (USD Millions, except per-share)

YoY comparisons (Q1 FY2026 vs Q1 FY2025):

• R&D: $13.1M vs $12.8M YoY
• G&A: $6.7M vs $4.2M YoY
• Net loss: $(18.2)M vs $(15.4)M YoY

Cash and Balance Sheet

Results vs Estimates

Values retrieved from S&P Global*

Guidance Changes

Earnings Call Themes & Trends

Note: No Q1 FY2026 earnings call transcript was available in the document set; themes below reflect company disclosures in Q3/Q4 press releases and the Q1 8‑K press release.

Management Commentary

• “We remain on track to report topline results from the Phase 3 sunRIZE trial in congenital hyperinsulinism in December.” — Nevan Charles Elam, CEO
• “In tumor hyperinsulinism, following FDA alignment on our streamlined Phase 3 trial and with enrollment now underway, we expect to both complete enrollment and report topline data in the second half of next year.” — Nevan Charles Elam, CEO
• “As we advance toward potential commercialization of ersodetug for the treatment of hyperinsulinism, we look forward to highlighting our progress at our investor event next week.” — Nevan Charles Elam, CEO

Q&A Highlights

• No Q1 FY2026 earnings call transcript was found in the available sources; management scheduled an Investor Event for 11/10/25 to address commercialization and program updates .

Estimates Context

• Q1 FY2026 EPS of $(0.18) beat the S&P Global consensus mean of $(0.261)* by $0.081; revenue remained at $0 with consensus $0.0* . Values retrieved from S&P Global*
• Prior quarters indicate a pattern of modest EPS misses (Q3: actual $(0.27) vs $(0.229); Q4: $(0.26) vs $(0.22)) before a Q1 beat, coincident with lower sequential R&D and higher non‑operating income . Values retrieved from S&P Global*

Where estimates may need to adjust:

• Street models may recalibrate OpEx cadence into the December topline event and 1H26 prep activities; consensus revenue likely remains $0 near‑term until commercialization visibility improves*. Values retrieved from S&P Global*

Key Takeaways for Investors

• December sunRIZE topline is the primary near‑term binary catalyst; FDA‑aligned tumor HI path (single‑arm Phase 3) reduces development risk on the second indication .
• Q1 EPS beat vs consensus reflects tighter OpEx sequentially and non‑operating income; monitor OpEx ramp into commercialization activities and investor event commentary . Values retrieved from S&P Global*
• Liquidity of $152.2M provides runway through pivotal readouts and tumor HI enrollment; sequential cash draw reflects ongoing trial and build‑out .
• Commercial readiness advancing (new CCO, investor event), positioning for potential BLA following positive sunRIZE results .
• Watch for any discrepancies or clarifications at the investor event regarding BLA timing, manufacturing readiness, and payer engagement for an ultra‑rare pediatric and oncology niche .
• If sunRIZE is positive, expect focus to shift to regulatory timelines, label breadth across HI, and initial market size assumptions; if negative, downside risk includes financing needs and program reprioritization .

Notes:

• No additional Q1 FY2026 press releases or an earnings call transcript were found in the document set searched (8‑K press release served as the earnings disclosure) .
• All estimates marked with * are Values retrieved from S&P Global.