Rezolute Reports Second Quarter Fiscal 2026 Financial Results and Provides Business Update
Rhea-AI Summary
Rezolute (Nasdaq: RZLT) reported Q2 fiscal 2026 results and a program update on Feb 12, 2026. The Phase 3 sunRIZE study of ersodetug in congenital hyperinsulinism did not meet its primary or key secondary endpoints, though some biomarker and CGM signals were observed.
The company achieved pharmacologic drug concentrations, all 59 completers entered the open‑label extension, and an FDA meeting under Breakthrough Therapy Designation is planned before end of Q1. Tumor HI upLIFT enrollment is ongoing with topline data expected H2 2026. Cash was $132.9M (Dec 31, 2025). Q2 net loss was $22.8M versus $15.7M year‑ago.
Positive
- Pharmacologic activity observed with target drug concentrations and biomarker responses
- All 59 study completers rolled into open‑label extension, most remaining on therapy
- Expanded Access data: 75% of 9 tumor HI patients discontinued IV dextrose/TPN
Negative
- sunRIZE Phase 3 did not meet its primary or key secondary endpoints
- Cash declined to $132.9M from $167.9M since June 30, 2025
- Net loss widened to $22.8M from $15.7M year‑ago
- G&A expenses increased to $9.9M from $4.5M; R&D rose to $14.3M from $12.6M
Market Reaction
Following this news, RZLT has declined 3.37%, reflecting a moderate negative market reaction. Our momentum scanner has triggered 37 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $3.51. This price movement has removed approximately $12M from the company's valuation.
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Key Figures
Market Reality Check
Peers on Argus
RZLT gained 9.77%, while peers RIGL, KALV, RLAY and TBPH rose between 0.1% and 3.33%; VIR slipped 0.87%, indicating generally positive biotech sentiment alongside RZLT’s move.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 06 | Q1 FY26 earnings | Neutral | +2.7% | Reported Q1 FY26 results, cash of $152.2M, and timelines for Phase 3 data. |
| Sep 17 | Q4/FY25 earnings | Neutral | -0.1% | Released Q4 and FY2025 results and confirmed Phase 3 plans and cash position. |
| May 13 | Q3 FY25 earnings | Neutral | -4.9% | Q3 FY2025 update with Breakthrough Therapy status and equity financing details. |
| Feb 12 | Q2 FY25 earnings | Neutral | -1.0% | Q2 FY2025 results and confirmation of Breakthrough and Orphan designations. |
| Nov 07 | Q1 FY25 earnings | Neutral | -2.5% | Q1 FY2025 results and progress updates on ersodetug Phase 3 programs. |
Earnings updates have historically produced modest single-day moves, with a slight negative average reaction and no large spikes.
Across the last five earnings or financial updates since November 2024, Rezolute has consistently highlighted progress of its Phase 3 sunRIZE and upLIFT programs while reporting ongoing net losses and rising R&D spend. Cash balances moved from $117.8M in Q1 FY2025 to $167.9M by FY2025 year-end, then to $152.2M in Q1 FY2026. These updates framed expectations for pivotal sunRIZE data and streamlined tumor HI development. Today’s Q2 FY2026 report continues this pattern, but now incorporates sunRIZE’s failure on primary endpoints and planning for an FDA meeting.
Historical Comparison
Past earnings headlines moved RZLT by an average of -1.17%. Today’s +9.77% reaction to Q2 FY2026 results is unusually strong versus prior quarters.
Earnings releases have tracked cash runway and sequential advancement of the ersodetug sunRIZE and upLIFT Phase 3 programs toward pivotal readouts and regulatory discussions.
Market Pulse Summary
This announcement combines Q2 FY2026 financials with an update on ersodetug programs in congenital and tumor hyperinsulinism. Key items include cash of $132.9M, higher R&D and G&A expenses, and a wider net loss of $22.8M. Clinically, sunRIZE failed its primary endpoints, but tumor HI data showed 75% of Expanded Access patients discontinuing IV dextrose/TPN. Compared with prior earnings updates, investors may focus on cash runway, the planned FDA meeting, and upcoming upLIFT Phase 3 topline results.
Key Terms
double-blind medical
placebo-controlled medical
continuous glucose monitoring (CGM) medical
open-label medical
Expanded Access Program (EAP) regulatory
Breakthrough Therapy Designation regulatory
glucose infusion rate (GIR) medical
total parenteral nutrition (TPN) medical
AI-generated analysis. Not financial advice.
REDWOOD CITY, Calif., Feb. 12, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), today reported financial results and provided a business update for the three months ended December 31, 2025.
Congenital Hyperinsulinism (HI)
- In December 2025, Rezolute reported topline results from sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI. The study did not meet its primary or key secondary endpoints.
- The study demonstrated reductions from baseline in hypoglycemia events by self-monitored blood glucose at both ersodetug dose levels, but reductions were not statistically significant compared to placebo, due to a pronounced study effect.
- A reduction in hypoglycemia time by continuous glucose monitoring (CGM) was also demonstrated with both dose levels of ersodetug, which was statistically significant compared to placebo at the Week 16 timepoint, but did not meet significance at the Week 24 end of pivotal timepoint.
- In sunRIZE, pharmacologic activity was observed, with target therapeutic drug concentrations achieved in both treatment groups, along with highly sensitive biomarker responses of decreased insulin cell signaling in the active treatment groups, indicating drug activity.
- Notably, all 59 participants who completed the study continued into the ongoing open-label extension portion, including the roll-over of placebo participants onto ersodetug, and the vast majority remain on therapy. Some of the children have been able to stop taking their standard congenital HI therapies and are now receiving ersodetug as monotherapy.
- Subsequent to the announcement of the topline results of the primary and key secondary endpoints, the Company is undertaking extensive analysis of the results and other endpoints, in preparation for its upcoming FDA meeting.
- The Company will be meeting with FDA prior to the end of the first quarter under Breakthrough Therapy Designation to determine next steps for the program.
Tumor HI
- upLIFT, a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment of tumor HI, is ongoing.
- Enrollment is underway and topline results are expected in the second half of 2026.
- In January 2026, the Company shared aggregate data from the initial 9 tumor HI patients treated under the historical Expanded Access Program (EAP).
- The data show that
75% of the patients receiving IV dextrose/total parenteral nutrition (TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN, providing additional evidence of the activity and potential efficacy of ersodetug across various forms of HI. - This cohort was the basis for FDA to grant Breakthrough Designation and agree to a single-arm, open-label registrational study design.
- The glucose infusion rate (GIR) assessment in the EAP is the primary endpoint in upLIFT, which measures the number of participants (out of approximately 16) who achieve at least a
50% reduction in GIR. - The full EAP data table, filed on Form 8-K with the U.S. Securities and Exchange Commission, can be found here.
- The data show that
Corporate Updates
- In November 2025, the Company hosted a virtual Investor Event during which Rezolute Chief Commercial Officer, Sunil Karnawat, discussed the anticipated commercial opportunities for ersodetug as a potential treatment for congenital and tumor HI. The event also featured presentations from two leading physician experts who provided perspectives on disease background and the significant unmet clinical need in HI.
- A replay of the virtual event is available on the Investor Relations section of the Company’s website here.
Second Quarter Fiscal 2026 Financial Results
Cash, cash equivalents and investments in marketable securities were
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Net loss was
About Ersodetug
Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI.
About Rezolute, Inc.
Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, is designed to treat all forms of HI and has been studied in clinical trials and used in real-world cases for the treatment of both congenital and tumor HI. For more information, visit www.rezolutebio.com.
Forward-Looking Statements
This release, like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. These forward-looking statements include, but are not limited to, the potential efficacy of ersodetug in treating hypoglycemia associated with either congenital or tumor HI, the possibility of FDA agreeing to a streamlined path for advancing the congenital HI program notwithstanding the lack of statistical significance in the sunRIZE study, or the timing of the release of topline results for upLIFT. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the U.S. Securities and Exchange Commission’s website at www.sec.gov. You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement.
Rezolute Contacts:
Christen Baglaneas
cbaglaneas@rezolutebio.com
508-272-6717
Carrie McKim
cmckim@rezolutebio.com
336-608-9706
| Rezolute, Inc. | |||||||||||||||||
| Condensed Consolidated Financial Statements Data | |||||||||||||||||
| (in thousands, except per share data) | |||||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||||
| December 31, | December 31, | ||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| Condensed Consolidated Statements of Operations Data: | |||||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 14,348 | $ | 12,627 | $ | 27,497 | $ | 25,381 | |||||||||
| General and administrative | 9,873 | 4,453 | 16,541 | 8,640 | |||||||||||||
| Total operating expenses | 24,221 | 17,080 | 44,038 | 34,021 | |||||||||||||
| Loss from operations | (24,221 | ) | (17,080 | ) | (44,038 | ) | (34,021 | ) | |||||||||
| Non-operating income, net | 1,447 | 1,350 | 3,114 | 2,913 | |||||||||||||
| Net loss | $ | (22,774 | ) | $ | (15,730 | ) | $ | (40,924 | ) | $ | (31,108 | ) | |||||
| Basic and diluted net loss per common share | $ | (0.22 | ) | $ | (0.22 | ) | $ | (0.40 | ) | $ | (0.45 | ) | |||||
| Shares used to compute basic and diluted net loss per common share | 103,687 | 69,940 | 103,555 | 69,838 | |||||||||||||
| December 31, | June 30, | ||||||||||||||||
| 2025 | 2025 | ||||||||||||||||
| Condensed Consolidated Balance Sheets Data: | |||||||||||||||||
| Cash and cash equivalents | $ | 11,944 | $ | 94,107 | |||||||||||||
| Investments in marketable debt securities | 120,994 | 73,751 | |||||||||||||||
| Working capital | 125,577 | 159,233 | |||||||||||||||
| Total assets | 138,629 | 175,490 | |||||||||||||||
| Accumulated deficit | (444,780 | ) | (403,856 | ) | |||||||||||||
| Total stockholders’ equity | 127,998 | 162,127 | |||||||||||||||
FAQ
What were the sunRIZE Phase 3 results for Rezolute (RZLT) announced Feb 12, 2026?
What is Rezolute's planned next step after the sunRIZE topline results for RZLT?
What did Rezolute report about tumor HI and the upLIFT study timeline for RZLT?
How did Rezolute's cash and losses look at Dec 31, 2025 for RZLT?
Did Rezolute report any positive clinical signals in the ersodetug program for RZLT?
