Rezolute Reports Fourth Quarter and Full Year Fiscal 2026 Financial Results and Provides Business Update
The tumor HI study is still enrolling, while the congenital HI results remain under FDA review.
Rhea-AI Summary
Rezolute (RZLT) reported fiscal 2026 results and updated its ersodetug studies on September 24, 2026.
In its ongoing Phase 3 upLIFT study for tumor-related hyperinsulinism (HI), seven of eight enrolled participants met the primary endpoint's responder criterion. Six also stopped intravenous glucose with ersodetug. The eighth participant withdrew before finishing the pivotal treatment phase and is counted as a non-responder. Enrollment continues; Rezolute expects topline results before the end of 2026. Its Phase 3 sunRIZE study in congenital HI did not meet its primary endpoint, and the data remain under FDA review.
Cash, cash equivalents and marketable securities totaled $107.8 million at June 30, 2026, versus $167.9 million a year earlier. Fiscal 2026 net loss was $77.6 million versus $74.4 million in fiscal 2025. Research and development expense fell to $53.8 million from $61.5 million, while general and administrative expense rose to $29.2 million from $18.4 million.
Positive
- upLIFT: seven of eight participants met the responder criterion.
- upLIFT: six participants stopped intravenous glucose with ersodetug.
- Quarterly net loss: $20.5 million versus $24.4 million a year earlier.
- Fiscal 2026 R&D expense: $53.8 million versus $61.5 million.
Negative
- Phase 3 sunRIZE did not meet its primary endpoint.
- Cash and marketable securities: $107.8 million versus $167.9 million a year earlier.
- Fiscal 2026 G&A expense: $29.2 million versus $18.4 million in fiscal 2025.
Key Figures
- upLIFT responders
- 7 of 8 participants
- Met the primary endpoint responder criterion
- upLIFT topline results
- Before the end of 2026
- Expected timing
- Cash, cash equivalents and marketable securities
- $107.8 million vs. $167.9 million
- June 30, 2026 vs. June 30, 2025
- R&D expenses
- $53.8 million vs. $61.5 million
- Fiscal 2026 vs. fiscal 2025
- G&A expenses
- $29.2 million vs. $18.4 million
- Fiscal 2026 vs. fiscal 2025
- Net loss
- $77.6 million vs. $74.4 million
- Fiscal 2026 vs. fiscal 2025
- Net loss
- $20.5 million vs. $24.4 million
- Fourth quarter fiscal 2026 vs. the prior-year quarter
Previous Earnings Reports
-
Reported fiscal results alongside expanded sunRIZE analyses and ongoing upLIFT enrollment
-
sunRIZE did not meet its primary or key secondary endpoints
-
Reported FDA alignment on BLA requirements and continued Phase 3 upLIFT enrollment
-
Reported sunRIZE enrollment completion and FDA alignment on the upLIFT study
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
single-arm technical
open-label extension medical
continuous glucose monitoring medical
total parenteral nutrition medical
meta-analysis technical
ecog performance status medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
REDWOOD CITY, Calif., Sept. 24, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), today reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2026.
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 in progress and topline results are expected before the end of 2026.
- Enrollment is in progress and topline results are expected before the end of 2026.
- In June 2026, the Company shared positive interim data from the upLIFT study, announcing that of the 8 participants enrolled, 6 had already met the responder criterion for the study’s primary endpoint within the 8-week pivotal treatment phase. Each of these 6 participants also achieved a complete discontinuation of intravenous glucose requirements with the administration of ersodetug. Since the time of this announcement, the seventh participant has also met the responder criterion for the study’s primary endpoint.
- One of the 8 enrolled participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status (ECOG 4). The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition, so the participant is being counted as a non-responder for purposes of assessing the primary endpoint.
- One of the 8 enrolled participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status (ECOG 4). The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition, so the participant is being counted as a non-responder for purposes of assessing the primary endpoint.
- In June 2026 at the Annual Meeting of the Endocrine Society (ENDO), Rezolute delivered a poster presentation highlighting favorable outcomes from a case series report of 9 patients with refractory hypoglycemia due to malignant insulinoma and non-islet cell tumors (tumor HI), demonstrating that
75% of the patients receiving IV dextrose/total parenteral nutrition (TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN.
- The outcomes of this case series were also recently published in manuscript form in The Journal of Clinical Endocrinology & Metabolism (JCEM), titled Ersodetug for refractory hypoglycemia due to malignant insulin-secreting tumors.
- The outcomes of this case series were also recently published in manuscript form in The Journal of Clinical Endocrinology & Metabolism (JCEM), titled Ersodetug for refractory hypoglycemia due to malignant insulin-secreting tumors.
Congenital HI
- In September 2026, the Company provided an update that data from the Phase 3 sunRIZE study in congenital HI, which did not meet its primary endpoint, remains under review with the U.S. Food and Drug Administration (FDA or Agency).
- In June 2026, the Company provided additional study data for the Agency’s independent review, including source and analysis datasets and summary results from a substantial number of pre-specified, post-hoc, and sensitivity analyses with a focus on continuous glucose monitoring (CGM) based glucose outcomes from the pivotal portion of the study.
- The open-label extension (OLE) phase of the sunRIZE study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in the use of background standard of care therapies.
- Rezolute will continue to await feedback and reserves the ability to request a formal meeting under a regulatory timeline, as needed.
- In June 2026, the Company provided additional study data for the Agency’s independent review, including source and analysis datasets and summary results from a substantial number of pre-specified, post-hoc, and sensitivity analyses with a focus on continuous glucose monitoring (CGM) based glucose outcomes from the pivotal portion of the study.
- In June 2026 at ENDO, Rezolute delivered three data presentations focused on congenital HI.
- In an oral presentation, Huseyin Demirbilek, M.D., Professor, Department of Pediatric Endocrinology, Hacettepe University Faculty of Medicine, Ankara, Turkey, and Principal Investigator of the Phase 3 sunRIZE study, reviewed previously reported results from the study.
- Two poster presentations highlighted results from systematic analyses of natural history and adverse neurologic and health-economic outcomes resulting from congenital HI, using a meta-analysis of the literature as well as a claims-based approach to quantifying congenital HI complications, respectively.
- In an oral presentation, Huseyin Demirbilek, M.D., Professor, Department of Pediatric Endocrinology, Hacettepe University Faculty of Medicine, Ankara, Turkey, and Principal Investigator of the Phase 3 sunRIZE study, reviewed previously reported results from the study.
Fourth Quarter and Full Year 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 pancreatic insulin or paraneoplastic IGF-2 secretion and from entero-incretin pathways, it has the potential to be universally effective at treating refractory hypoglycemia due to any form of hyperinsulinism (HI), including congenital HI, tumor HI (insulinoma, non-islet cell tumors) or bariatric/non-bariatric gastrointestinal surgery hypoglycemia. Ersodetug for the treatment of HI is investigational. Statements about safety and efficacy have not been approved by any health authority.
About Rezolute, Inc.
Rezolute is a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due to a variety of causes of 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 as well as our ability to complete enrollment of the upLIFT study this year and announce topline results. Our ability to predict results or our plans or strategies is inherently uncertain. Notably, no assurance can be given that FDA will agree with the Company that there is evidence of clinically meaningful benefit observed in the sunRIZE study and accordingly the Agency could make the determination that the only path forward for the congenital HI indication is a new randomized control trial similar to sunRIZE. Should the Agency make such a determination, that would adversely impact the Company’s ability to further pursue that indication as well as the commercial potential for ersodetug. 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 | Year Ended | ||||||||||||||
| June 30, | June 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Condensed Consolidated Statements of Operations Data: | |||||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 14,889 | $ | 20,863 | $ | 53,798 | $ | 61,527 | |||||||
| General and administrative | 6,673 | 4,987 | 29,168 | 18,367 | |||||||||||
| Total operating expenses | 21,562 | 25,850 | 82,966 | 79,894 | |||||||||||
| Loss from operations | (21,562 | ) | (25,850 | ) | (82,966 | ) | (79,894 | ) | |||||||
| Non-operating income, net | 1,071 | 1,460 | 5,380 | 5,482 | |||||||||||
| Net loss | $ | (20,491 | ) | $ | (24,390 | ) | $ | (77,586 | ) | $ | (74,412 | ) | |||
| Basic and diluted net loss per common share | $ | (0.20 | ) | $ | (0.26 | ) | $ | (0.75 | ) | $ | (0.98 | ) | |||
| Shares used to compute basic and diluted net loss per common share | 104,488 | 94,340 | 103,907 | 75,999 | |||||||||||
| June 30, | June 30, | ||||||||||||||
| 2026 | 2025 | ||||||||||||||
| Condensed Consolidated Balance Sheets Data: | |||||||||||||||
| Cash and cash equivalents | $ | 10,615 | $ | 94,107 | |||||||||||
| Investments in marketable debt securities | 97,186 | 73,751 | |||||||||||||
| Working capital | 99,093 | 159,233 | |||||||||||||
| Total assets | 112,849 | 175,490 | |||||||||||||
| Accumulated deficit | (481,442 | ) | (403,856 | ) | |||||||||||
| Total stockholders’ equity | 100,687 | 162,127 | |||||||||||||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Rezolute's Phase 3 upLIFT study show?
Seven of eight enrolled participants met the study's primary endpoint responder criterion. Six of those participants also completely stopped intravenous glucose with ersodetug. The seventh responder met the criterion after Rezolute's June 2026 interim update; enrollment remains in progress.
How did Rezolute's fiscal 2026 cash and net loss compare with fiscal 2025?
Cash, cash equivalents and marketable securities were $107.8 million at June 30, 2026, compared with $167.9 million at June 30, 2025. Fiscal 2026 net loss was $77.6 million, compared with $74.4 million in fiscal 2025.
Why did Rezolute's fiscal 2026 general and administrative expenses rise?
Rezolute attributed the increase primarily to higher employee-related stock-based compensation and professional fees incurred in preparation for future ersodetug commercial activities. Share-based compensation included in general and administrative expense was $8.0 million in fiscal 2026, versus $3.6 million in fiscal 2025.
Why was one participant in Rezolute's upLIFT study counted as a non-responder?
The participant withdrew consent and stopped ersodetug and other non-palliative therapies before completing the pivotal treatment phase. Intravenous glucose was reduced and eventually stopped during the participant's transition to hospice care, so the participant is counted as a non-responder for the primary endpoint.
What additional sunRIZE data did Rezolute provide to the FDA?
In June 2026, Rezolute provided source and analysis datasets and summary results from pre-specified, post-hoc and sensitivity analyses for the FDA's independent review. The analyses focused on glucose outcomes measured by continuous glucose monitoring during the pivotal portion of the study.