Rezolute's FY2026 net loss widened to $77.6M as R&D fell and pre-launch G&A rose 59%. Cash and investments fell to $107.8M after the sunRIZE Phase 3 miss, with upLIFT tumor-HI topline data due by end-2026.
Net income
-$78M
Diluted EPS
$-0.75
Overview
Rezolute is a clinical-stage drug developer: it has no approved product and no revenue in either fiscal 2026 or 2025 (its fiscal year ends June 30). For a company like this, the usual revenue-and-margin analysis doesn't apply. What matters instead is how much money it spends each year (mostly on research and development, or R&D), how much cash it has left, how long that cash lasts (its "runway"), how often it has to sell new shares to raise more (which shrinks existing holders' share of the company, known as "dilution"), and whether its drug is progressing in clinical trials.
Fiscal 2026 was defined by one setback and one encouraging interim result, both for the same drug, ersodetug, an antibody given by IV drip that is meant to treat dangerously low blood sugar (hypoglycemia) caused by hyperinsulinism (HI), where the body produces too much insulin:
Congenital HI (in children): in December 2025 the Phase 3 sunRIZE study did not meet its primary endpoint or its key secondary endpoint. The FDA is still reviewing the data, with no timeline set.
Tumor HI (in adults with insulin-producing tumors): the Phase 3 upLIFT study reported that 7 of its first 8 participants met the study's responder criterion, with topline results expected before the end of 2026.
Financially, the net loss widened slightly to $77.6 million from $74.4 million. The mix changed: R&D fell 13% while general and administrative (G&A) costs rose 59%. Cash, cash equivalents and investments dropped to $107.8 million from $167.9 million, and the company raised almost no new money during the year.
Key figures
Metric
FY2026 (year to Jun 30, 2026)
FY2025
YoY Change
Revenue
$0
$0
n/a
Research & development expense
$53.8M
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$61.5M
-13%
General & administrative expense
$29.2M
$18.4M
+59%
Operating loss
-$83.0M
-$79.9M
Loss $3.1M wider
Interest & other income
$5.4M
$5.5M
-2%
Net loss
-$77.6M
-$74.4M
Loss $3.2M wider
Net loss per share (basic & diluted)
-$0.75
-$0.98
Loss per share $0.23 smaller
Weighted-average shares outstanding
103.9M
76.0M
+37%
Cash used in operations
-$64.6M
-$69.1M
$4.4M less cash used
Cash, cash equivalents & investments (year-end)
$107.8M
$167.9M
-$60.1M
FY2025 year-end cash and investments are the sum of cash and cash equivalents ($94.1M) and marketable debt securities ($73.8M) on the balance sheet.
The loss per share shrank even though the total loss grew, and that is not an operating improvement. The average share count rose 37%, mostly because of the stock sold in the April 2025 public offering and the 2024–2025 private placements, which count for a full year in fiscal 2026. The same loss spread over more shares gives a smaller per-share figure.
Where the money went
R&D fell $7.7 million, to $53.8 million. Per the 10-K, the decline came mainly from:
$9.3 million less spent on drug manufacturing. The prior year included process-validation manufacturing runs (the final batches that show a factory can reliably make the drug) to supply the sunRIZE extension, upLIFT and expanded-access programs.
$5.0 million less in license milestone payments. A one-time $5.0 million milestone to licensor XOMA came due in May 2025, when the last sunRIZE patient was dosed, and there was no equivalent payment this year.
These cuts were partly offset by $1.1 million more in upLIFT clinical costs (site activations and enrollment), $0.6 million more for patients continuing in the sunRIZE open-label extension (56 participants as of June 30, 2026), a $3.4 million rise in R&D compensation ($3.0 million of it stock-based) and $0.9 million of severance.
G&A rose $10.8 million, to $29.2 million. The drivers were $5.7 million more compensation ($4.4 million of it stock-based pay), $4.6 million for business development, market research and planning for a potential commercial launch of ersodetug, and $0.5 million more severance.
Stock-based pay doubled. Stock-based compensation, which is paid in shares and options rather than cash, rose to $14.5 million from $7.1 million. That is why the accounting loss grew while the cash actually spent on operations fell by $4.4 million, to $64.6 million.
Workforce reduction. On December 15, 2025, four days after the sunRIZE results, Rezolute cut 29 employees (21 in R&D and 8 in G&A), with $1.5 million of severance recorded across the two lines.
Interest income was flat at $5.4 million. The company held larger average investment balances, but the yield on those holdings fell from 4.35% to 3.78%.
Cash, runway and dilution
At June 30, 2026, Rezolute held $10.6 million in cash and cash equivalents plus $97.2 million in marketable debt securities, all of which mature within the following 12 months. Working capital (short-term assets minus short-term liabilities) was about $99.1 million. Its losses since the company was founded total $481.4 million.
Management's runway statement: capital resources are sufficient to fund operations "for at least 12 months" from the issuance of these financial statements. The company also says it "will need to obtain additional equity or debt financing" to fund its long-term requirements.
Simple arithmetic check (ours, not the company's): at fiscal 2026's operating cash burn of $64.6 million, $107.8 million would last about 1.7 years. That assumes spending stays flat, and a BLA submission and launch preparations would probably raise it.
Financing this year: only $2.2 million came in, mainly from employees exercising stock options, compared with $107.3 million in fiscal 2025 (a $97.3 million underwritten offering plus two private placements). In October 2025 Rezolute ended its $50 million at-the-market program with Jefferies (a standing arrangement that lets a company sell shares gradually on the open market) without ever having sold any shares through it.
Future obligations: if ersodetug is approved by any regulator, a $25.0 million milestone becomes payable to the licensor (XOMA, which Ligand Pharmaceuticals acquired on July 14, 2026). Up to $185.0 million more in sales-based milestones would follow, plus royalties.
The share count to watch includes both ordinary shares and pre-funded warrants. Pre-funded warrants are rights to shares that have already been almost fully paid for, and they count in per-share figures. There were 96.7 million common shares outstanding on September 21, 2026, and the pre-funded warrants issued between 2021 and 2025 cover up to 28.2 million more shares.
Takeaway: Rezolute's finances now depend on a single near-term event: the upLIFT topline readout in tumor HI, expected before the end of 2026. The pivotal study needs roughly 9 responders out of about 16 participants to succeed, and 7 of the first 8 have met the responder criterion. A clean result would support a BLA (the application to the FDA to approve a biologic drug) in mid-2027, just as the $107.8 million cash pile, down $60 million this year, would need topping up. That would let the company raise money from a position of strength rather than after the congenital HI setback.
Pipeline status, as the 10-K describes it
sunRIZE (congenital HI): the study missed its primary endpoint (hypoglycemia events measured by finger-stick blood tests) and its key secondary endpoint (time spent hypoglycemic measured by continuous glucose monitors, or CGM) at the Week 24 evaluation window. Rezolute argues that a large placebo effect and behavioral factors distorted the results. In other words, families who closely monitored glucose and stepped in may have improved outcomes in both groups. It points to nominally significant reductions of more than 50% in CGM time-in-hypoglycemia versus placebo across multiple time points. "Nominally significant" means those analyses weren't the study's pre-set primary test, so they carry less statistical weight. At a March 17, 2026 meeting, the FDA acknowledged these challenges but "reiterated the expectation for adequate and well-controlled studies." As of September 2026 the agency is still reviewing the data, with no specific timeline, and the outcome could require another study. All 59 participants who completed sunRIZE chose to continue on ersodetug, and 56 remain in the open-label extension.
upLIFT (tumor HI): in August 2025 the FDA agreed to a streamlined, single-arm design with no placebo group and about 16 participants who depend on continuous IV glucose. A participant counts as a responder if their IV glucose need falls by at least 50% during the 8-week treatment period. Statistical success requires roughly 9 of 16 responders. The June 2, 2026 interim update reported that 6 of the first 8 participants responded, each of them coming off IV glucose entirely, and a seventh has responded since. The eighth, who had stage 4 metastatic colon cancer, withdrew to hospice care and is counted as a non-responder.
Other: the RZ402 plasma kallikrein inhibitor program, previously in development for diabetic macular edema, remains paused after Phase 2. The company is exploring other uses for it.
Outlook
Management's stated priorities through the first half of 2027 are:
Reach agreement with the FDA on a path forward in congenital HI.
Complete enrollment in upLIFT and report its topline results.
If the data support it, submit a BLA for ersodetug in mid-2027.
Our read: the numbers this year matter less than what they imply for the next 12–18 months. The shift in spending from manufacturing toward commercial planning, together with the workforce cut, shows a company slimming its R&D base while preparing to launch in the one indication that still looks on track. The main risks are:
upLIFT is small. It is a single-arm study of about 16 patients, so each remaining responder or non-responder moves the result materially.
The congenital HI answer is open-ended. The FDA review has no timeline, and a request for another trial would add cost the current cash doesn't clearly cover.
Dilution is likely. Rezolute states that it will need outside financing for its long-term plans, so existing shareholders should expect further share issuance.