RZLT

REDWOOD CITY, Calif., May 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 March 31, 2026. Congenital Hyperinsulinism (HI) In May 2026, expanded analyses from the Phase 3 sunRIZE study of ersodetug in patients with congenital HI were presented via oral presentation at the Pediatric Endocrine Society (PES) 2026 Annual Meeting by Diva D. De León-Crutchlow, M.D., M.S.C.E., Chief of the Division of Endocrinology and Diabetes, Director of the Congenital Hyperinsulinism Center at Children’s Hospital of Philadelphia, and Principal Investigator of the sunRIZE study. In addition to the previously reported topline results, the presentation included results from additional continuous glucose monitoring (CGM)-based outcomes, which demonstrated significant and consistent improvements in glycemic control in ersodetug treatment arms compared to placebo, across multiple pre-specified and post-hoc endpoints. Average daily percent time in hypoglycemia by CGM: clinically relevant and nominally statistically significant reductions of >50% (Full Analysis Set [FAS]) and ~60-80% (Per Protocol Set [PPS]), compared to placebo across multiple timepoints Average weekly hypoglycemia events by CGM: clinically relevant and nominally statistically significant reductions of ~50-65% (FAS) and ~50-80% (PPS), compared to placebo across multiple timepoints Average daily AUC 70 to 180 mg/dL (Exposure to Normoglycemia) by CGM: clinically relevant and nominally statistically significant increases of ~25-50% (FAS and PPS), compared to placebo across multiple timepoints Average blood glucose (mg/dL) by CGM: clinically relevant and nominally statistically significant increases of ~10-15% (~10-15 mg/dL) in both the FAS and PPS, compared to placebo across multiple timepoints Participation, retention, and treatment duration in the open-label extension (OLE) following the completions of the study is high and has resulted in continued glycemic benefit, concurrent with the reduction and/or discontinuation of background standard of care therapies. In March 2026, Rezolute announced outcomes from an in-person Type B meeting with the U.S. Food and Drug Administration (F...

Includes results from additional continuous glucose monitoring (CGM)-based outcomes which demonstrate significant and consistent improvements in glycemic control in ersodetug treatment arms compared to placebo, across multiple pre-specified and post-hoc endpoints Participation, retention, and treatment duration in the open-label extension (OLE) phase of the study is high and has resulted in continued glycemic benefit, concurrent with the reduction and/or discontinuation of background standard of care (SOC) therapies REDWOOD CITY, Calif., May 01, 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 announced that expanded analyses from the Phase 3 sunRIZE study of ersodetug in patients with congenital HI were presented at the Pediatric Endocrine Society (PES) 2026 Annual Meeting. The oral presentation was made by Diva D. De León-Crutchlow, M.D., M.S.C.E., Chief of the Division of Endocrinology and Diabetes, Director of the Congenital Hyperinsulinism Center at Children’s Hospital of Philadelphia, and Principal Investigator of the sunRIZE study. In addition to the previously reported topline results, the presentation included additional results from pre-specified and post-hoc sunRIZE analyses, which the Company believes reiterates evidence of target engagement and highlights the potential therapeutic benefit of ersodetug. As discussed in today’s presentation, although statistical significance for the secondary endpoint (% time in hypoglycemia by CGM) was not achieved at the Week 24/End of Treatment evaluation window, larger and often nominally statistically significant glycemic improvements were consistently observed throughout the maintenance dosing phase of the study, across time and numerous pre-specified and post-hoc CGM-based endpoints. These outcomes are summarized below and depicted by the Forest Plot in Figure 1. Summary of Key Additional Data Presented Average daily percent time in hypoglycemia by CGM: clinically relevant and nominally statistically significant reductions of >50% (Full Analysis Set [FAS]) and ~60-80% (Per Protocol Set [PPS]), compared to placebo across multiple timepoints Average weekly hypoglycemia events by CGM: clinically relevant and nominally statistically significant reductions of...

Oral presentation will include previously announced topline results as well as pre-specified and post-hoc data updates REDWOOD CITY, Calif., April 21, 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 announced that results from the Phase 3 sunRIZE study of ersodetug in congenital HI were accepted for an oral presentation at the Pediatric Endocrine Society (PES) Annual Meeting being held April 30-May 3, 2026, in San Francisco, CA. In addition to the previously reported topline results, the presentation will also include results from pre-specified and post-hoc sunRIZE analyses, which the Company believes continue to demonstrate target engagement and the therapeutic benefit of ersodetug. Presentation Title: Top-Line Results From a Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (sunRIZE) Format: Oral presentation Presenter: Diva D. De León-Crutchlow, MD, MSCE Session Date and Time: Friday, May 1, 2026, from 8:15 a.m. – 9:15 a.m. PT Session Title: Oral Abstracts #1 For more information on the conference presentation schedule, please visit the PES Annual Meeting website. About sunRIZE The Phase 3 sunRIZE study (RZ358-301) was a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital hyperinsulinism (HI), ages 3 months to 45 years old, who were experiencing continued hypoglycemia on currently available standard of care (SOC). Eligible participants were randomized to one of three treatment arms to receive either ersodetug (5 or 10 mg/kg) or matched placebo-control as add on to existing SOC. Study drug was administered every other week during an initial loading phase, and then every 4 weeks during the 6-month controlled pivotal treatment period. Following the pivotal treatment phase of the study, participants could roll-over into an optional open-label extension phase to continue to receive ersodetug. The study enrolled 63 participants in more than a dozen countries around the world, inclusive of U.S. patients. The primary and key secondary efficacy endpoints in the study were the change from baseline in the average number of hypoglycemia events per week and the average perce...

XOMA called 2025 a “foundational year,” adding 22 assets and reporting total portfolio receipts of more than $50 million, including $34 million of royalties (up 68% year‑over‑year), achieving positive cash flow and repurchasing $16 million of shares. Through a December revenue‑share transaction with Takeda and prior purchases (including $20 million from BioInvent), XOMA shifted some mezagitamab rights to secure economic interests across nine development‑stage assets that could deliver low‑ to mid‑single‑digit royalties and up to $853 million in milestones. While two Phase III programs (Rezolute and Gossamer) missed statistical significance, XOMA still holds 14 registrational‑stage programs with multiple 2026 catalysts—such as Rezolute top‑line data, volixibat VISTAS results, REC‑4881 FDA engagement and additional AstraZeneca TIGIT data—and developers plan FDA meetings to pursue paths forward. Interested in XOMA Royalty Corporation? Here are five stocks we like better. XOMA Royalty (NASDAQ:XOMA) executives used the company’s 2025 financial results call to emphasize a year of portfolio expansion, rising royalty receipts, and what management described as progress toward a business model in which recurring royalties can cover core operating costs. Chief Executive Officer Owen Hughes said 2025 was a “foundational year” as the company continued executing its strategy to build a diversified portfolio of biotechnology royalty and milestone assets. Hughes said XOMA added 22 assets to its portfolio during 2025, along with the acquisition of two platform technologies the company hopes to outlicense for future royalties and milestones. → Why Credo and Astera Soared After Oracle and Broadcom's Earnings Hughes said total portfolio receipts surpassed $50 million in 2025, including $34 million of royalty receipts, which he said grew 68% versus fiscal 2024. He also said XOMA maintained a lean operating structure, achieved positive cash flow from operations, and returned $16 million through share repurchases during 2025, retiring more than 5% of common shares outstanding. With seven commercially available programs, Hughes said the company is building a “diverse and growing source of recurring receipts.” He pointed to early-stage commercial launches for Day One Biopharmaceuticals’ OJEMDA and Zevra Therapeutics’ MIPLYFFA, and noted that both companies submitted marketing author...

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 Januar...

REDWOOD CITY, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today reported financial results and provided a business update for the three months ended September 30, 2025. “We remain on track to report topline results from the Phase 3 sunRIZE trial in congenital hyperinsulinism in December,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “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. 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.” Recent Pipeline Progress and Anticipated Milestones Congenital Hyperinsulinism (HI) sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI, is ongoing. Topline results are expected in December 2025. Company has alignment with FDA that the study meets registrational requirements necessary for a BLA filing and review. Tumor HI In August 2025, the Company achieved alignment with FDA on a significantly streamlined clinical development path for its Phase 3 registrational program of ersodetug for the treatment of tumor HI. A truncated, single-arm, open-label, Phase 3 study (upLIFT) in up to 16 hospitalized participants is considered acceptable as the adequate and well-controlled study to support registration, removing the need to conduct a double-blind randomized placebo-controlled trial. Enrollment is underway and topline results are expected in the second half of 2026. Corporate Updates On November 10, 2025, Rezolute will host a virtual Investor Event via webcast from 12:00-1:30 pm ET. During the event, Rezolute Chief Commercial Officer, Sunil Karnawat, will discuss the anticipated commercial opportunities for ersodetug as a potential treatment for congenital and tumor HI. In addition, Rezolute management will review the Company’s ongoing clinical development programs, including the Phase 3 sunRIZE and upLIFT trials. The call will also feature remarks from two leading physici...

Rezolute (RZLT) reported fiscal Q4 loss late Wednesday of $0.26 per diluted share, narrowing from a

Fourth Quarter and Full Year Fiscal 2025 Financial Results Cash, cash equivalents and investments in marketable securities were $167.9 million as of June 30, 2025, compared with $127.1 million as of June 30, 2024. Research and development (R&D) expenses were $20.9 million for the fourth quarter of fiscal 2025, compared with $19.1 million for the same period a year ago. Full fiscal year 2025 R&D expenses were $61.5 million, compared to $55.7 million in fiscal year 2024. The increase from fiscal year 2024 to fiscal year 2025 was primarily due to (i) increased expenditures in clinical trial activities, (ii) manufacturing costs for ersodetug, and (iii) higher employee-related expenses, which included employee compensation and stock-based compensation. General and administrative (G&A) expenses were $5.0 million for the fourth quarter of fiscal 2025, compared with $4.0 million for the same period a year ago. Full fiscal year 2025 G&A expenses were $18.4 million, compared to $14.7 million in fiscal year 2024. The increase was primarily attributable to professional fees and employee-related expenses due to increased headcount. Net loss was $24.4 million for the fourth quarter of fiscal 2025 compared with a net loss of $23.0 million for the same period a year ago. Full year fiscal 2025 net loss was $74.4 million compared to net loss of $68.5 million for the fiscal year 2024. 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 shown meaningful benefit in clinical trials and real-world use 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 re...

Business development: Purchased mezagitamab royalty and milestone rights held by BioInvent International and will secure royalty economic interests in two early-stage partnered assets through XOMA Royalty’s recently announced acquisition of LAVA Therapeutics. Company acquisitions: Announced XOMA Royalty’s acquisitions of Turnstone Biologics, LAVA Therapeutics, and HilleVax; acted as structuring agent and provided financing for XenoTherapeutics’ acquisition of ESSA Pharma; completed the sale of Kinnate pipeline assets and distributed upfront proceeds to Kinnate contingent value right (CVR) holders. Key Pipeline advancements: Rezolute completed enrollment in Phase 3 sunRIZE study of ersodetug in patients with congenital hyperinsulinism; the Marketing Authorization Application (MAA) for Day One Biopharmaceuticals and Ipsen’s tovorafenib was accepted for review by the European Marketing Authority (EMA), resulting in a $4 million milestone payment to XOMA Royalty; Zevra Therapeutics submitted an MAA with EMA seeking marketing approval for arimoclomol as a treatment for Niemann-Pick Type C. Cash receipts: In the first half of 2025, XOMA Royalty received $29.6 million in royalties and milestones from its partners, including $11.7 million during the second quarter. EMERYVILLE, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its 2025 second quarter and year to date financial results and highlighted recent actions that have the potential to deliver shareholder value. “We continue to add to our diversified portfolio of both early- and late-stage assets through disciplined capital deployment and creative financial structures,” stated Owen Hughes, Chief Executive Officer of XOMA Royalty. “Recently approved drugs are addressing key unmet patient needs, which is driving increased royalty receipts, and we await data from several key Phase 3 assets over the coming quarters.” Royalty and Milestone Acquisitions Company Acquisitions Pipeline Partner Updates through August 8, 2025 Anticipated 2025 Partner Events of Note Second Quarter and Year to Date 2025 Financial Results Tom Burns, Chief Financial Officer of XOMA Royalty, commented, “In the first six months of 2025, we have received $29.6 million in cash from partners, of which $16.0 million were royalty payments related to commercial sales and $13.6...

sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial results and provided a business update for the three months ended March 31, 2025. “The Phase 3 sunRIZE study in congenital HI is on track to complete enrollment this month and we are poised to start our registrational upLIFT study for tumor HI mid-year,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “Each of our programs received Breakthrough Therapy Designation from FDA this year. We look forward to continued discussions with the agency with a focus on treating hypoglycemia caused by all forms of hyperinsulinism with the goal of advancing our novel therapy towards approval and commercialization.” Recent Pipeline Progress and Anticipated Milestones Congenital HI sunRIZE, a Phase 3, multicenter, double-blind, randomized, controlled safety and efficacy registrational study, is ongoing and enrollment is expected to conclude in May 2025. U.S. sites are activated and enrolling patients. Topline results expected in December 2025. Upon completion of an interim analysis in April 2025, an independent Data Monitoring Committee recommended continuation of the sunRIZE study as planned without an increase to the study sample size. The analysis was intended to evaluate the study for futility or otherwise to inform a potential sample size increase, for purposes of optimizing the study power and statistical confidence in the final analysis outcomes. The Company remains blinded to the results. Tumor HI In May 2025, FDA granted Breakthrough Therapy Designation (BTD) to ersodetug for the treatment of hypoglycemia due to tumor HI. BTD was granted based on clinical trial data across the overall HI program and a recognition of the mechanistic applicability to tumor HI, further validated by real-world experience in tumor HI patients who have been successfully treated with ersodetug throughout the U.S. in the Company's Expanded Access Program. A regist...