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RZLT

RezoluteD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-06-17
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Investor releaseQuarter not tagged2026-06-17

Rezolute Highlights Results Presented from Natural History Outcomes Studies and its Ersodetug Clinical Program in Hyperinsulinism at Annual Meeting of the Endocrine Society

GlobeNewswire
Presentations included analyses of natural history and adverse outcomes in congenital hyperinsulinism (HI), as well as previously reported results from the Company’s Phase 3 sunRIZE study in congenital HI and a case series from its Expanded Access Program (EAP) in tumor HI REDWOOD CITY, Calif., June 17, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), today highlighted four data presentations delivered at the Annual Meeting of the Endocrine Society (ENDO). Two poster presentations highlighted results from systematic analyses of the 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. This is an important step toward consolidating and quantifying the disease-impact and informing future health economics and outcomes research that will facilitate the development and potential future launch of the Company’s therapy, ersodetug, in this indication. A third poster presentation highlighted 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. 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 of ersodetug in congenital HI, reviewed previously reported sunRIZE results. “We were pleased to have the opportunity to present at ENDO and to continue showcasing progress across our two late-stage programs in congenital and tumor HI,” said Brian Roberts, M.D., Chief Medical Officer of Rezolute. “Deeper analyses of the sunRIZE data demonstrate the meaningful therapeutic benefit of ersodetug, further supported by the positive outcomes observed in both our EAP and recently announced interim and preliminary Phase 3 upLIFT study observations in tumor HI patients. Additionally, the natural history outcom…Read full document

Presentations included analyses of natural history and adverse outcomes in congenital hyperinsulinism (HI), as well as previously reported results from the Company’s Phase 3 sunRIZE study in congenital HI and a case series from its Expanded Access Program (EAP) in tumor HI REDWOOD CITY, Calif., June 17, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), today highlighted four data presentations delivered at the Annual Meeting of the Endocrine Society (ENDO). Two poster presentations highlighted results from systematic analyses of the 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. This is an important step toward consolidating and quantifying the disease-impact and informing future health economics and outcomes research that will facilitate the development and potential future launch of the Company’s therapy, ersodetug, in this indication. A third poster presentation highlighted 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. 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 of ersodetug in congenital HI, reviewed previously reported sunRIZE results. “We were pleased to have the opportunity to present at ENDO and to continue showcasing progress across our two late-stage programs in congenital and tumor HI,” said Brian Roberts, M.D., Chief Medical Officer of Rezolute. “Deeper analyses of the sunRIZE data demonstrate the meaningful therapeutic benefit of ersodetug, further supported by the positive outcomes observed in both our EAP and recently announced interim and preliminary Phase 3 upLIFT study observations in tumor HI patients. Additionally, the natural history outcomes studies further underscore the significant clinical outcomes impacts of this disease, and the urgent need for improved treatment options.” Each of the Company’s full data presentations from ENDO can be found on the Publications and Presentations page of the Rezolute website here. 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 glucose absorption, gastrointestinal incretin hormones, and pancreatic insulin secretion, it has the potential to be universally effective at treating refractory hypoglycemia due to a congenital or any acquired form of HI, including tumor HI (insulinoma, NICTH) or hypoglycemia as a complication of a variety of bariatric or non-bariatric gastrointestinal surgeries. About Rezolute, Inc. Rezolute is a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired 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. 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 [email protected] 508-272-6717 Carrie McKim [email protected] 336-608-9706

Investor releaseQuarter not tagged2026-05-13

Rezolute Reports Third Quarter Fiscal 2026 Financial Results and Provides Business Update

GlobeNewswire
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…Read full document

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 (FDA) held on March 17, 2026, related to the sunRIZE study. FDA acknowledged the challenges posed by the potential impact of varied behavioral factors on clinical trials in this heterogeneous patient population, including the associated limitations of self-monitored blood glucose (SMBG) based metrics in measuring hypoglycemia in congenital HI. FDA encouraged Rezolute to submit comprehensive analysis datasets and summary outcomes for the agency’s independent evaluation. The Company expects to have an update on the program in the second half of 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 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 full EAP data table, filed on Form 8-K with the U.S. Securities and Exchange Commission, can be found here. Third Quarter Fiscal 2026 Financial Results Cash, cash equivalents and investments in marketable securities were $120.3 million as of March 31, 2026, compared with $167.9 million as of June 30, 2025. Research and development (R&D) expenses were $11.4 million for the third quarter of fiscal 2026, compared with $15.3 million for the same period a year ago. The decrease from fiscal year 2025 to fiscal year 2026 was primarily due to (i) decreased manufacturing costs for ersodetug and (ii) decreased clinical trial activities. R&D expenses include $1.9 million of share-based compensation expense for the third quarter of fiscal 2026, compared with $0.9 million for the same period a year ago. General and administrative (G&A) expenses were $6.0 million for the third quarter of fiscal 2026, compared with $4.7 million for the same period a year ago. The increase was primarily attributable to increased employee-related stock-based compensation expense, partially offset by a decrease in professional fees. G&A expenses include $2.5 million of share-based compensation expense for the third quarter of fiscal 2026, compared with $1.0 million for the same period a year ago. Net loss was $16.2 million for the third quarter of fiscal 2026 compared with a net loss of $18.9 million for the same period a year ago. 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 predictive nature of the CGM data as it relates to the potential efficacy of ersodetug in treating hypoglycemia, the ability of the Company to provide study reports and analysis datasets for the FDA’s independent evaluation, the persuasiveness of the study reports and analysis datasets and the possibility of FDA agreeing to advance the congenital HI program based on those study reports and analysis datasets notwithstanding the lack of statistical significance in the sunRIZE study. 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 [email protected] 508-272-6717 Carrie McKim [email protected] 336-608-9706

Investor releaseQuarter not tagged2026-05-02

Rezolute Announces Oral Presentation of Results From its Phase 3 sunRIZE Study of Ersodetug in Patients with Congenital Hyperinsulinism at the Pediatric Endocrine Society Annual Meeting

GlobeNewswire
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…Read full document

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 ~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 Figure 1: Consistent and Clinically Relevant Glycemic Improvements in Ersodetug Treatment Groups Compared to Placebo Across Time & Multiple CGM Outcomes (LS-Mean [95% CI] Percent Change from Baseline; FAS Population) The Company is also assessing the longer-term efficacy and safety of ersodetug in a real-world setting in an ongoing OLE phase of the study, including the roll-over of placebo participants. Following the conclusion of the randomized and placebo-controlled phase of sunRIZE, all 59 study completers elected to enter the OLE, as previously reported by the Company. Reflecting no change since last reported, 57 participants continue to attend regular study visits at sunRIZE study centers to receive ersodetug in the OLE, now representing a cumulative ersodetug exposure duration in the study ranging from approximately 6 to 24 months. Preliminary OLE observations demonstrate continued glycemic benefit, including a clinically significant change in glycemic control in the rolled-over placebo participants compared to the controlled period of the study. These glycemic benefits have enabled a concurrent significant overall reduction in background SOC therapies (e.g. diazoxide, somatostatin analogs, and/or regular tube feeds), with a significant number of patients now receiving ersodetug as monotherapy. Notably, a summary of these same CGM-based study outcomes and preliminary observations from the OLE phase of the study were recently discussed with the U.S. Food and Drug Administration (FDA) as part of the Company’s Type B meeting held on March 17, 2026. The meeting resulted in the agency acknowledging challenges associated with the study primary endpoint (events by finger-stick self-monitored blood glucose [SMBG]), and concluded with the agency requesting that the Company submit the broader study data for the agency’s comprehensive evaluation to inform next steps for the program. “We are pleased to highlight that deeper analyses of the sunRIZE outcomes and ongoing observations from the extension phase of the study consistently indicate evidence of target engagement, drug activity, and the potential for meaningful therapeutic benefit from ersodetug,” said Brian Roberts, M.D., Chief Medical Officer of Rezolute. “These results underscore our confidence in the potential of ersodetug to transform the HI treatment landscape and embolden our mission to achieve alignment with FDA on an acceptable path to approval in this indication, so that we can keep delivering ersodetug to patients and families living with congenital HI.” The Company’s full data presentation from PES can be found on the Publications and Presentations page of the Rezolute website here. 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 percent time in hypoglycemia, respectively, over six months of treatment. Although sunRIZE demonstrated reductions from baseline in hypoglycemia events, the study did not meet its primary endpoint, which assessed change in average weekly hypoglycemia events by self-monitored blood glucose (SMBG) compared to placebo. The reductions observed were not statistically significant, which the Company believes was a result of functional unblinding of the SMBG endpoint, leading to divergent and confounding glucose-modifying behaviors between treatment groups, and a pronounced study effect in the placebo arm. 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 sufficiency of CGM data to support a potential path forward in the congenital HI program with FDA, the predictive nature of the CGM data as it relates to the potential efficacy of ersodetug in treating hypoglycemia, the ability of the Company to provide study reports and analysis datasets for the FDA’s independent evaluation, the persuasiveness of the study reports and analysis datasets and the possibility of FDA agreeing to advance the congenital HI program based on those study reports and analysis datasets notwithstanding the lack of statistical significance in the sunRIZE study. 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. Diva D. De León-Crutchlow, M.D., M.S.C.E., is a paid consultant to Rezolute Inc., and served as the site Principal Investigator for the Phase 3 sunRIZE study at Children’s Hospital of Philadelphia. Rezolute Contacts: Christen Baglaneas [email protected] 508-272-6717 Carrie McKim [email protected] 336-608-9706 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d26d1af6-0969-4bba-b973-6d2294367aae

Investor releaseQuarter not tagged2026-04-21

Rezolute to Present Results from its Phase 3 sunRIZE Study in Congenital Hyperinsulinism at the Pediatric Endocrine Society (PES) Annual Meeting

GlobeNewswire
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…Read full document

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 percent time in hypoglycemia, respectively, over six months of treatment. 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. 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 [email protected] 508-272-6717 Carrie McKim [email protected] 336-608-9706

Investor releaseQuarter not tagged2026-03-19

XOMA Royalty Q4 Earnings Call Highlights

MarketBeat
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…Read full document

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 authorizations in the European Union in 2025. Hughes also cited Ipsen’s Feb. 26, 2026 announcement of a positive CHMP opinion recommending conditional marketing authorization for OJEMDA in the EU. He added that Ipsen submitted a marketing authorization in Japan in the fourth quarter, which triggered a $2 million milestone payment to XOMA. → Members of Congress Bought These 5 Stocks—Should You? Hughes acknowledged that the company is not immune to clinical setbacks. He said two Phase III programs—Rezolute’s congenital hyperinsulinism program and Gossamer Bio’s seralutinib for pulmonary arterial hypertension—showed clinical efficacy but failed to meet statistical significance thresholds versus control arms. However, Hughes said both companies remain committed to exploring options in 2026. He said Rezolute plans to meet with the FDA before the end of the first quarter under its breakthrough designation after further analysis of primary results and other endpoints. Hughes also said Gossamer plans to meet with the FDA to discuss a path forward for seralutinib, citing a pre-specified intermediate- and high-risk subgroup analysis that showed a 20-meter placebo-adjusted six-minute walk distance improvement with a P value of 0.0207, and noted that three of four secondary endpoints met a P value threshold of less than 0.0125. → Palantir’s New Partnership Continues Separating Fact From Fiction Looking forward, Hughes said XOMA’s broader portfolio includes 14 programs in registrational stage and outlined developer-guided potential events in calendar 2026, including: Rezolute: top-line results from a separate Phase III program evaluating ersodetug in tumor hyperinsulinism in the second half of 2026 Volixibat: top-line results from the VISTAS study in primary sclerosing cholangitis (PSC) in the second quarter of 2026 REC-4881: developer engagement with the FDA in the first half of 2026 to align on a registrational study in familial adenomatous polyposis (FAP) AstraZeneca TIGIT program: additional data in various solid tumors throughout 2026 Chief Investment Officer Brad Sitko said XOMA added 22 new portfolio assets in 2025, including five in Phase II or Phase III trials, with total upfront cash outlay of $25 million. Sitko said XOMA’s late-stage portfolio additions were largely driven by a revenue-sharing transaction executed in December with Takeda related to mezagitamab. Sitko said XOMA purchased additional mezagitamab royalty and milestone rights from BioInvent for $20 million earlier in 2025. XOMA then reduced some of its aggregated mezagitamab rights in exchange for economic rights across nine development-stage assets in Takeda’s externalized asset portfolio. Sitko said the Takeda transaction could provide low- to mid-single-digit royalties and up to $853 million in milestones across the nine assets. Following the transaction, he said XOMA’s mezagitamab participation moved from a mid-single-digit royalty and $16.25 million in potential milestones to a low single-digit royalty and up to $13 million in potential milestones. Among the Takeda-related development-stage assets Sitko highlighted were osavampator (Phase III in major depressive disorder), volixibat (Phase 2B in PSC and primary biliary cholangitis), OHB-607 (Phase II in bronchopulmonary dysplasia in extremely premature infants), and REC-4881 (Phase II in FAP). Sitko also emphasized XOMA’s use of whole-company acquisitions and special situations, saying the company completed or served as structuring agent on seven acquisitions. He said XOMA accumulated $11.7 million of non-dilutive capital net of expenses from those transactions, and obtained interests in partnered assets and potential future out-licensing proceeds, citing collaborations involving Lava Therapeutics (Johnson & Johnson and Pfizer), Generation Bio (Moderna), and legacy Kinnate assets. Sitko said XOMA obtained economic interests in “approximately 25%” of more than $1.1 billion of potential milestone payments and low- to mid-single-digit royalties from eight partnered assets, as well as eligibility for 25% to 70% of proceeds from any future out-license or sale of certain legacy assets or platform technologies. Chief Financial Officer Jeffrey Trigilio reported full-year 2025 total GAAP income and revenue of $52.1 million, up from $28.5 million in 2024. On a cash basis, he said total receipts increased 9% to $50.5 million, including about $34 million from royalties, up 68% year over year. Trigilio said the increase was driven by VABYSMO and OJEMDA growth, along with a new contribution from MIPLYFFA following its approval for Niemann-Pick disease type C in late 2024. He said royalty receipts in 2025 came from four programs, two more than in 2024, and that six programs generated clinical, regulatory, and business development events, resulting in about $17 million of cash milestone payments. On expenses, Trigilio reported full-year G&A expense of $36 million, compared with $34.5 million in 2024. He said 2025 G&A included non-cash stock-based compensation of $9.3 million, and included an increase of about $1.1 million tied to litigation XOMA initiated against Janssen Biotech alleging breach of contract and unjust enrichment related to Janssen’s use of XOMA intellectual property in the commercialization of Tremfya. Trigilio noted that Johnson & Johnson has reported cumulative Tremfya net revenues of approximately $19.7 billion since 2017, but emphasized litigation is uncertain and there is no assurance on outcome, timing, or recovery amount. GAAP net income for 2025 was $31.7 million, compared with a GAAP net loss of $13.8 million in 2024. Trigilio cited accounting items that contributed to GAAP results with limited cash impact, including $21.2 million of gains from acquisitions (HilleVax, Turnstone, and Mural), a $3.7 million gain on sale of equity securities, and $3.0 million of amortization expense for intangible assets. Trigilio also highlighted balance sheet and capital allocation items, including $25 million deployed for royalty and milestone interests and $16 million used to repurchase and retire slightly more than 648,000 shares at an average price of $24.75. XOMA ended 2025 with about $83 million of unrestricted cash and cash equivalents. He said the company reduced principal on its Blue Owl loan from $123 million to $112.5 million; he described the facility as self-amortizing and funded solely by VABYSMO receipts with no recourse to XOMA or other assets. If VABYSMO net revenues continue to grow at similar—or slightly lower—rates than 2025, Trigilio said the loan could be fully repaid by the end of 2030, at which point VABYSMO receipts would return to XOMA for a few years, while noting the loan can be repaid at any time. During questions, Trigilio said growth prospects for royalty receipts “look strong,” pointing to VABYSMO as the largest contributor and to continued ramp for OJEMDA and MIPLYFFA, while declining to provide specific guidance. On the Tremfya litigation, Hughes said the company and its legal advisors have “a lot of confidence” in the breach claim, which he said relates to an agreement with MorphoSys dating to the 2003 timeframe involving phage display and HuCal technologies used to create Tremfya. Hughes said royalty rates in similar relationships are typically low single digits, but noted the agreement structure was different and could affect remuneration if XOMA is successful. Hughes also provided detail on the platform technologies acquired through Generation Bio, emphasizing XOMA does not intend to become a drug development company or fund R&D internally. He said Generation Bio’s cell-specific LNP delivery technology has non-human primate data suggesting metabolism bypasses the liver and may be re-dosable. Hughes said Moderna has certain rights, but XOMA believes it can license the technology outside Moderna’s field of use to generate royalties and milestones, including potential value for Generation Bio shareholders through contingent value rights. He added that a second technology, iqDNA, is earlier stage and that XOMA is speaking with third parties to fund work aimed at eventual monetization. In another exchange, Hughes described the company’s approach to capital deployment as balancing portfolio investments with share repurchases to increase free cash flow per share over time, while still aiming to diversify across modality, indication, sponsor, and geography. XOMA Royalty (NASDAQ: XOMA) is a specialty healthcare royalty company that acquires and manages royalty interests in small-molecule and biologic drugs. The company's business model centers on purchasing royalty streams on marketed or near-market pharmaceutical products, providing capital to developers in exchange for a share of future net sales. By focusing on late-stage assets with established clinical and commercial profiles, XOMA Royalty aims to generate predictable, long-term cash flows for its shareholders. The company's investment portfolio spans a range of therapeutic areas, including oncology, immunology and rare diseases. The article "XOMA Royalty Q4 Earnings Call Highlights" was originally published by MarketBeat.

Investor releaseQuarter not tagged2026-02-13

Rezolute Reports Second Quarter Fiscal 2026 Financial Results and Provides Business Update

GlobeNewswire
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…Read full document

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. 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 $132.9 million as of December 31, 2025, compared with $167.9 million as of June 30, 2025. Research and development (R&D) expenses were $14.3 million for the second quarter of fiscal 2026, compared with $12.6 million for the same period a year ago. The increase from fiscal year 2025 to fiscal year 2026 was primarily due to (i) increased expenditures in clinical trial activities and (ii) higher employee-related expenses, which included one-time severance benefits related to the December 2025 reduction in force, partially offset by a decrease in manufacturing costs for ersodetug. General and administrative (G&A) expenses were $9.9 million for the second quarter of fiscal 2026, compared with $4.5 million for the same period a year ago. The increase was primarily attributable to increased professional fees and employee-related expenses, which included one-time severance benefits related to the December 2025 reduction in force. Net loss was $22.8 million for the second quarter of fiscal 2026 compared with a net loss of $15.7 million for the same period a year ago. 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 [email protected] 508-272-6717 Carrie McKim [email protected] 336-608-9706

Investor releaseQuarter not tagged2025-11-07

Rezolute Reports First Quarter Fiscal 2026 Financial Results and Provides Business Update

GlobeNewswire
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…Read full document

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 physician experts in hyperinsulinism: Mansa Krishnamurthy, M.D., Pediatric Endocrinologist, Cincinnati Children’s Hospital Medical Center and Assistant Professor, Department of Pediatrics, University of Cincinnati; and Azeez Farooki, M.D., Attending Physician and Clinical Member, Endocrinology Service, Memorial Sloan Kettering Cancer Center and Associate Clinical Professor, Weill Cornell Medical College. First Quarter Fiscal 2026 Financial Results Cash, cash equivalents and investments in marketable securities were $152.2 million as of September 30, 2025, compared with $167.9 million as of June 30, 2025. Research and development (R&D) expenses were $13.1 million for the first quarter of fiscal 2026, compared with $12.8 million for the same period a year ago. The increase from fiscal year 2025 to fiscal year 2026 was primarily due to (i) increased expenditures in clinical trial activities and (ii) higher employee-related expenses, which included employee compensation and stock-based compensation, partially offset by a decrease in manufacturing costs for ersodetug. General and administrative (G&A) expenses were $6.7 million for the first quarter of fiscal 2026, compared with $4.2 million for the same period a year ago. The increase was primarily attributable to professional fees and employee-related expenses due to increased headcount. Net loss was $18.2 million for the first quarter of fiscal 2026 compared with a net loss of $15.4 million for the same period a year ago. 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 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 timing of the release of topline results from the sunRIZE trial, the applicability of ersodetug across multiple forms of hyperinsulinism, the timing of the release of topline results from the upLIFT study, the ability of ersodetug to become an effective treatment for congenital hyperinsulinism, the effectiveness or future effectiveness of ersodetug for the treatment of congenital hyperinsulinism, and statements regarding clinical trial timelines for ersodetug. 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 the Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’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 [email protected] 508-272-6717 Carrie McKim [email protected] 336-608-9706

Investor releaseQuarter not tagged2025-09-18

Rezolute Fiscal Q4 Loss Narrows

MT Newswires

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

Investor releaseQuarter not tagged2025-09-18

Rezolute Reports Fourth Quarter and Full Year Fiscal 2025 Financial Results and Provides Business Update

GlobeNewswire
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…Read full document

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 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 timing of the release of topline results from the sunRIZE trial, the applicability of ersodetug across multiple forms of hyperinsulinism, the timing of the release of topline results from the upLIFT study, the ability of ersodetug to become an effective treatment for congenital hyperinsulinism, the effectiveness or future effectiveness of ersodetug for the treatment of congenital hyperinsulinism, and statements regarding clinical trial timelines for ersodetug. 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 the Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’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. Contacts: Rezolute, Inc. Christen Baglaneas [email protected] 508-272-6717

Investor releaseQuarter not tagged2025-08-13

XOMA Royalty Reports Second Quarter and Year to Date 2025 Financial Results and Highlights Recent Business Achievements

GlobeNewswire
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 $1…Read full document

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 million in milestone payments and fees. In the second quarter, we received $11.7 million in cash, $2.6 million from our partners’ commercial sales and $9.0 million from milestones and fees. Our partners’ product marketing activities continue to be well executed and as new commercial opportunities within our portfolio emerge, our line of sight to becoming cash flow positive on a consistent basis exclusively from the cash payments received from royalties grows clearer. With this outlook, we deployed $1.8 million to repurchase 81,682 shares of our common stock in the second quarter, bringing the total number of shares repurchased in 2025 to over 107,500 shares.” Income and Revenue: Income and revenue for the three and six months ended June 30, 2025, were $13.1 million and $29.0 million, respectively, as compared with $11.1 million and $12.6 million for the corresponding periods of 2024. The increase in both periods presented was primarily driven by increased income related to VABYSMO and OJEMDA. Research and Development (R&D) Expenses: R&D expenses for the three and six months ended June 30, 2025, were $0.1 million and $1.4 million, respectively, compared with $1.2 million for each of the corresponding periods of 2024. The R&D expenses in the first quarter of 2025 and the three- and six-month periods of 2024 were related to the clinical trial costs incurred subsequent to XOMA Royalty’s acquisition of Kinnate in April 2024 related to KIN-3248 and the associated wind-down activities. General and Administrative (G&A) Expenses: G&A expenses for the three and six months ended June 30, 2025, were $7.8 million and $15.9 million, respectively, as compared with $11.0 million and $19.5 million for the corresponding periods of 2024. The decrease in the second quarter of 2025 compared to the second quarter of 2024 was primarily due to the $3.6 million in exit packages paid to Kinnate senior leadership in the second quarter of 2024. In 2025, XOMA Royalty’s G&A expenses included non-cash stock-based compensation expenses during the three and six months ended June 30, 2025, of $1.6 million and $3.6 million, respectively, as compared to $2.7 million and $5.5 million for the corresponding periods of 2024. The 2024 periods reflect non-cash stock-based compensation related to the appointment of Mr. Hughes to full-time Chief Executive Officer and issuance of performance stock units. Credit Losses on Purchased Receivables: In the second quarter of 2024, XOMA Royalty recorded a one-time, non-cash credit loss on purchased receivables of $9.0 million and a corresponding reduction of royalty receivables of $9.0 million associated with the Aronora assets. To date there have been no credit losses in 2025. Amortization of Intangible Assets: Amortization of intangible assets relates to the IP acquired in the Company’s acquisitions of Pulmokine in November 2024 and the mezagitamab economics from the BioInvent transaction in May 2025. Amortization of non-cash intangible assets were $0.7 million and $1.2 million for the three and six months ended June 30, 2025. Gain on Acquisition of Kinnate: In the second quarter of 2024, XOMA Royalty recorded a $19.3 million gain on the acquisition of Kinnate due to the fair value of net assets that exceeded total purchase consideration. Interest Expense: For the three and six months ended June 30, 2025, interest expense was $3.2 million and $6.7 million, respectively, as compared with $3.4 million and $7.0 million for the corresponding periods of 2024. Interest expense relates to the Blue Owl Loan established in December 2023. Other Income, net: For the three and six months ended June 30, 2025, other income, net was $7.8 million and $7.7 million, respectively, as compared with $2.1 million and $4.0 million for the corresponding periods of 2024. The increases for the periods presented were primarily driven by increases in the fair value of XOMA Royalty’s investments in equity securities. Net Income: XOMA Royalty reported net income of $9.2 million and $11.6 million for the three and six months ended June 30, 2025, as compared to $16.0 and $7.4 million in the corresponding periods of 2025. Cash Position: On June 30, 2025, XOMA Royalty had cash and cash equivalents of $78.5 million (including $3.4 million in restricted cash), compared with cash and cash equivalents of $106.4 million (including $4.8 million in restricted cash) on December 31, 2024. In the second quarter of 2025, XOMA Royalty received $11.7 million in cash receipts including $2.6 million in royalties and commercial payments and $9.0 million in milestones and fees. During the second quarter of 2025, XOMA Royalty deployed $20 million to acquire additional economics in mezagitamab, repurchased approximately 81,700 shares of XOMA Royalty common stock for a cost of $1.8 million, and paid $1.4 million in dividends on the XOMA Royalty Perpetual Preferred stocks. In the first six months of 2025, XOMA Royalty received $29.6 million in cash receipts, including $16.0 million in royalties and commercial payments and $13.6 million in milestone payments and fees. During the first half of 2025, XOMA Royalty deployed $25.0 million to acquire additional assets for its royalty and milestone portfolio, repurchased approximately 107,500 shares of its common stock for a cost of $2.4 million, and paid $2.7 million in dividends on the XOMA Royalty Perpetual Preferred stocks. About XOMA Royalty Corporation XOMA Royalty is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA Royalty acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA Royalty acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com or follow XOMA Royalty Corporation on LinkedIn. Forward-Looking Statements/Explanatory Notes Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA Royalty and other developments related to VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), MIPLYFFA™ (arimoclomol), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], DSUVIA® (sufentanil sublingual tablet), and Sildenafil Cream, 3.6%; the potential occurrences of the events listed under “Anticipated 2025 Events of Note”; the anticipated timings of regulatory filings and approvals related to assets in XOMA Royalty’s portfolio; and the potential of XOMA Royalty’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA Royalty’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; and if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them. Other potential risks to XOMA Royalty meeting these expectations are described in more detail in XOMA Royalty's most recent filing on Form 10-Q and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA Royalty's prospects. Any forward-looking statement in this press release represents XOMA Royalty's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA Royalty disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, the commercial assets in XOMA Royalty’s milestone and royalty portfolio are VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), MIPLYFFA™ (arimoclomol), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet). All other assets in the milestone and royalty portfolio are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. 1 https://ir.rezolutebio.com/news/detail/354/rezolute-receives-breakthrough-therapy-designation-from-fda-for-ersodetug-in-the-treatment-of-hypoglycemia-due-to-tumor-hyperinsulinism 2 https://ir.rezolutebio.com/news/detail/356/rezolute-announces-completion-of-enrollment-in-the-phase-3-sunrize-study-of-ersodetug-in-patients-with-congenital-hyperinsulinism 3 https://www.ipsen.com/press-releases/ipsen-delivers-strong-sales-in-the-first-quarter-2025-and-confirms-its-full-year-guidance-3062256/ 4 https://investors.zevra.com/news-releases/news-release-details/zevra-therapeutics-submits-marketing-authorization-application 5 https://ir.gossamerbio.com/news-releases/news-release-details/gossamer-bio-announces-completion-enrollment-registrational 6 https://ir.gossamerbio.com/news-releases/news-release-details/gossamer-bio-announces-second-quarter-2025-financial-results-and 7 https://ir.darebioscience.com/news-releases/news-release-details/positive-interim-phase-3-results-highlight-potential-ovaprener 8 https://ir.rezolutebio.com/news/detail/337/rezolute-announces-fda-clearance-of-ind-application-for-phase-3-registrational-study-of-rz358-for-treatment-of-hypoglycemia-due-to-tumor-hyperinsulinism 9 https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-and-rosy-wellness-announce-strategic 10 https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-phase-3-plans-sildenafil-cream-36

Investor releaseQuarter not tagged2025-05-14

Rezolute Reports Third Quarter Fiscal 2025 Financial Results and Provides Business Update

GlobeNewswire
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…Read full document

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 registrational study for ersodetug in patients with tumor HI, the “upLIFT” study, is anticipated to begin in the middle of 2025 with topline data expected in the second half of 2026. Utilizing BTD, the Company plans to engage further with FDA to discuss the registrational trial, including the necessary data package to support a BLA filing and potential approval for the tumor HI indication. Corporate Updates In March 2025, the Company announced the appointment of rare disease commercial leader, Erik Harris, to its Board of Directors. Mr. Harris is an experienced board member and commercial executive with a proven track record in the industry, currently serving as Chief Commercial Officer at Ultragenyx. His insights will be invaluable as the Company advances through clinical development and prepares for potential commercialization. In April 2025, the Company announced the closing of an underwritten offering raising approximately $97 million. Cash runway extended to middle of 2027. The net proceeds will be used for research and development, general corporate expenses and working capital needs. Fiscal Third Quarter Financial Results Cash, cash equivalents and investments in marketable securities were $88.4 million as of March 31, 2025, compared to $127.1 million as of June 30, 2024. Research and development expenses were $15.3 million for the third quarter of fiscal 2025, compared with $12.4 million for the same period a year ago, with the increase primarily attributable to increased expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses, which include employee compensation. General and administrative expenses were $4.7 million for the third quarter of fiscal 2025, compared with $3.8 million for the same period a year ago, with the increase primarily attributable to professional fees and employee-related expenses as a result of increased headcount. Net loss was $18.9 million for the third quarter of fiscal 2025 compared with a net loss of $17.1 million for the same period a year ago. 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 substantial benefit in clinical trials and real-world use for the treatment of congenital HI 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, statements regarding the third quarter financial results of Rezolute, the efficacy of ersodetug in the congenital or tumor patient population, the timeline for the completion of enrollment or achieving results in either of our Phase 3 programs and the potential approval and commercialization of ersodetug. 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 the Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’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. Contacts: Rezolute, Inc. Christen Baglaneas [email protected] 508-272-6717 Media Sarah Lima [email protected] (774) 766-0200

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