Rezolute, Inc.

Previous wording

We are a late-stage rare disease company focused on developing biologics that significantly improve the quality of life for patients and their families.

Current wording

We are a late-stage rare disease company focused on developing therapies that substantially improve the quality of life for individuals living with hyperinsulinism (“HI”) by alleviating the burden of severe and debilitating hypoglycemia.

Previous wording

Our priorities for 2026 are to progress our two Phase 3 programs in congenital and tumor hyperinsulinism (“HI”). Our goals include (i) achieve alignment with the U.S. Food and Drug Administration (“FDA”) on the path forward in congenital HI, (ii) complete enrollment in the registrational tumor HI study and (iii) announce topline data from the registrational tumor HI study.

Current wording

Our priorities for the second half of 2026 are to: (i) achieve alignment with the U.S. Food and Drug Administration (“FDA”) on the path forward in congenital HI following the completion of the sunRIZE study and (ii) complete enrollment and announce topline data for the registrational Phase 3 upLIFT study.

Previous wording

On December 11, 2025, we announced that the sunRIZE study did not meet its primary (hypoglycemia events) or key secondary (time in hypoglycemia) endpoints. The study demonstrated reductions from baseline in events and time in hypoglycemia in both treatment groups, but not enough to be statistically significant compared to the pronounced study effect in the placebo arm. We believe the pronounced placebo/study effect confounded the results, particularly for hypoglycemia events by self-monitored glucometer, but that the totality of the data further supports previous clinical evidence that ersodetug is active against hypoglycemia in patients. Specifically, there was evidence of pharmacologic activity, as target therapeutic drug concentrations were achieved in both treatment groups (5 mg/kg and 10 mg/kg) with highly sensitive biomarker responses (increases in circulating insulin) in the active treatment groups that are directly indicative of reduced insulin activity at its receptor, which biologically implies fewer cell-surface glucose transporters, and a resultant increase in blood glucose.

Current wording

While we believe the pronounced placebo/study effect confounded the results, with a particular impact on the primary endpoint of hypoglycemia events by self-monitored blood glucose (“SMBG”) due to accompanying measurement bias, the totality of the data further supports previous clinical evidence that ersodetug is active against hypoglycemia in patients. Specifically, there was evidence of pharmacologic activity, as target therapeutic drug concentrations were achieved in both treatment groups (5 mg/kg and 10 mg/kg) with highly sensitive biomarker responses (increases in circulating insulin) in the active treatment groups that are directly indicative of reduced insulin activity at its receptor, which biologically implies fewer cell-surface glucose transporters, and a resultant increase in blood glucose.

Previous wording

While additional analyses are ongoing, initial observations from sunRIZE inform our belief that the pharmacologic response demonstrates therapeutic activity, which may be obscured by the nature of patient-monitored hypoglycemia endpoint, and hypoglycemia-avoidant confounding behaviors. The magnitude of the placebo response observed for hypoglycemia events was a surprise to us and reveals a significant challenge in studying glucose in an ambulatory setting, where intensive visits and monitoring is inevitable and can independently influence outcomes, particularly when the patient-monitored glucose is simultaneously the safety lifeline for patient and families.

Current wording

Based on our analyses, observations from sunRIZE inform our belief that the pharmacologic response demonstrates therapeutic activity, which may have been obscured by the unblinded nature of SMBG necessary for patient standard of care, along with perceptions of treatment assignment. The magnitude of the placebo response observed for hypoglycemia events by SMBG was unexpected and reveals a significant challenge in studying glucose in an ambulatory setting, where real-time glycemic monitoring can independently influence outcomes, particularly when the patient-monitored glucose is simultaneously the safety lifeline for patient and families.

Previous wording

In light of these limitations, assessing the potential benefit in the ongoing open-label extension (“OLE”) portion of the study will be important, including blood glucose levels in the placebo group following roll-over to ersodetug. All 59 participants who completed the study elected to continue to receive ersodetug in the OLE. To date, 57 participants remain in the OLE, with an exposure duration ranging from ~3 months for the most recently entered patients, to ~21 months. We believe that a potential indicator of ersodetug’s underlying efficacy is an observed reduction in overall background standard of care (“SOC”) therapies in the OLE, including several children who have discontinued SOC and tube feeds and are now receiving ersodetug as monotherapy.

Current wording

All 59 participants who completed the study elected to continue to receive ersodetug in the OLE. To date, 57 participants remain in the OLE, with an exposure duration ranging from ~6 months for the most recently entered patients, 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, which we believe is a potential indicator of ersodetug’s underlying efficacy.

Previous wording

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 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. The initial 8 infant participants

Current wording

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 HI, ages 3 months to 45 years old, who were experiencing continued hypoglycemia on currently available 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. The initial 8 infant participants (ages 3 months – 1 year old) were enrolled open-label but subsequent participants in this age range could be enrolled into the double-blind randomized, controlled trial (“RCT”). Study drug was administered every other week during an initial loading phase, and then every 4 weeks during the 24-Week 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.

Previous wording

Congenital HI is the most common cause of recurrent and persistent hypoglycemia in children. Individuals with congenital HI typically present with signs or symptoms of hypoglycemia shortly after birth. Hypoglycemia can result in significant brain injury and death if not recognized and managed appropriately. Additionally, recurrent, or cumulative, hypoglycemia can lead to progressive and irreversible damage over time, including serious and devastating brain injury, seizures, neuro-developmental problems, feeding difficulties, and significant impact on patient and family quality of life. In cases where individuals have diffuse disease, a near-total pancreatectomy may be undertaken, although ongoing medical treatment of hypoglycemia is generally required for several years after surgery, before eventual insulin-dependent diabetes ensues. There are no FDA approved therapies for all forms of congenital HI, and the current standard of care treatments are suboptimal. The treatments used by physicians today include glucagon, diazoxide, somatostatin analogues and pancreatectomy. We estimate that in the U.S. alone, the initial addressable pediatric market for congenital HI is more than 1,500 individuals. We believe this addressable population will increase with the elimination of near-total pancreatectomy (“NTP”) and use of ersodetug in patients on diazoxide who experience side effects or are partially responsive.

Current wording

Congenital HI is the most common cause of recurrent and persistent hypoglycemia in children. Individuals with congenital HI typically present with signs or symptoms of hypoglycemia shortly after birth. Hypoglycemia can result in significant brain injury and death if not recognized and managed appropriately. Additionally, recurrent, or cumulative, hypoglycemia can lead to progressive and irreversible damage over time, including serious and devastating brain injury, seizures, neuro-developmental problems, feeding difficulties and significant impact on patient and family quality of life. In cases where individuals have diffuse disease, a near-total pancreatectomy (“NTP”) may be undertaken, although ongoing medical treatment of hypoglycemia is generally required for several years after surgery, before eventual insulin-dependent diabetes ensues. There are no FDA approved therapies for all forms of congenital HI, and the current standard of care treatments are suboptimal. The treatments used by physicians today include glucagon, diazoxide, somatostatin analogues and pancreatectomy. We estimate that in the U.S. alone, the initial addressable pediatric market for congenital HI is more than 1,500 individuals. We believe this addressable population will increase with the elimination of NTP and use of ersodetug in patients on diazoxide who experience side effects or are partially responsive.

Previous wording

In mid-2025 we initiated the Phase 3 registrational study (“upLIFT”) of ersodetug for the treatment of hypoglycemia due to tumor HI. Topline results from the study are anticipated to be available in the second half of calendar 2026, but the specific date of the availability of such results may vary.

Current wording

In mid-2025 we initiated the Phase 3 registrational study (“upLIFT”) of ersodetug for the treatment of hypoglycemia due to tumor HI. The Company anticipates completing enrollment and announcing topline results from the study in the second half of calendar 2026.

Previous wording

At a meeting held with FDA on August 19, 2025, the agency agreed to modifications to the design of the upLIFT study including removing the need to conduct a randomized, double-blind, placebo-controlled trial with hypoglycemia events as the endpoint. The truncated upLIFT study is a Phase 3 registrational, single-arm, open-label, pivotal trial in as few as 16 participants with insulinoma or paraneoplastic non-islet cell tumors, who are requiring continuous parenteral dextrose because of refractory hypoglycemia. Eligible participants requiring continuous parenteral dextrose will receive ersodetug 9 mg/kg per week for 8 weeks, as an add-on to standard of care. Following this 8-week pivotal treatment period, all participants may receive ersodetug in long-term extension, with the discretion to decrease the dosing frequency to every 2 to 4 weeks. The primary endpoint is the number of participants able to achieve at least a 50 percent reduction from baseline in the rate of continuous parenteral dextrose (glucose infusion rate; “GIR”), where 60% of participants would need to reach the endpoint to be considered statistically significant. Additional endpoints include the time to discontinuation of glucose infusion, time to discharge from the hospital, extent of hypoglycemia events and hypoglycemia time in the outpatient setting by SMBG and CMG, respectively, and patient reported quality of life.

Current wording

At a meeting held with FDA on August 19, 2025, the agency agreed to modifications to the design of the upLIFT study including removing the need to conduct a randomized, double-blind, placebo-controlled trial with hypoglycemia events as the endpoint. The streamlined upLIFT study is a Phase 3, registrational, single-arm, open-label, pivotal trial in approximately 16 participants with insulinoma or paraneoplastic non-islet cell tumors, who require continuous parenteral dextrose because of refractory hypoglycemia. Eligible participants requiring continuous parenteral dextrose will receive ersodetug 9 mg/kg per week for 8 weeks, as an add-on to standard of care. Following this 8-week pivotal treatment period, all participants may receive ersodetug in long-term extension, with the discretion to decrease the dosing frequency to every 2 to 4 weeks. The primary endpoint is the proportion of participants able to achieve at least a 50 percent reduction from baseline in the rate of continuous parenteral dextrose (glucose infusion rate; “GIR”), where statistical significance would be achieved if the lower bound of the 95% confidence interval of the point estimate exceeds 30% (equating to a responder rate of ~9 of 16 participants). Additional endpoints include the time to discontinuation of glucose infusion, time to discharge from the hospital, extent of hypoglycemia events and hypoglycemia time in the outpatient setting by SMBG and CMG, respectively, and patient reported quality of life.

Previous wording

glucocorticoids that are used to attempt to treat the hypoglycemia. Tumor-directed therapies do not directly treat hypoglycemia caused by insulinomas or NICTs. In many cases, tumor-directed therapies are administered concurrently with medical therapies for hypoglycemia and in other cases successful treatment of hypoglycemia often enables the initiation and/or continuation of tumor-directed therapies, as indicated. During the period from diagnosis to surgical treatment, or if surgery is contraindicated or refused, medical treatments are often necessary to directly manage the HI and hypoglycemia induced by the tumor. Additionally, chronic medical management of refractory hypoglycemia is often necessary for patients who cannot be cured by surgery, such as those with extensive disease of the pancreas, multi-focal insulinomas, inoperable or unresectable benign or malignant insulinomas, metastatic insulinomas, non-pancreatic insulinomas, or NICT hypoglycemia resulting from a variety of other tumors.

Current wording

Current therapies for insulinomas and NICTs can be grouped into two main categories: (a) tumor-directed de-bulking therapies (e.g., surgery, chemotherapy, radiotherapy), which may indirectly and/or eventually lead to decreased levels of circulating insulin and/or insulin-like substances, and therefore control HI and related hypoglycemia; and/or (b) medical therapies such as Diazoxide and glucocorticoids that are used to attempt to treat the hypoglycemia. Tumor-directed therapies do not directly treat hypoglycemia caused by insulinomas or NICTs. In many cases, tumor-directed therapies are administered concurrently with medical therapies for hypoglycemia and in other cases successful treatment of hypoglycemia often enables the initiation and/or continuation of tumor-directed therapies, as indicated. During the period from diagnosis to surgical treatment, or if surgery is contraindicated or refused, medical treatments are often necessary to directly manage the HI and hypoglycemia induced by the tumor. Additionally, chronic medical management of refractory hypoglycemia is often necessary for patients who cannot be cured by surgery, such as those with extensive disease of the pancreas, multi-focal insulinomas, inoperable or unresectable benign or malignant insulinomas, metastatic insulinomas, non-pancreatic insulinomas or NICT hypoglycemia resulting from a variety of other tumors.

Previous wording

We maintain an EAP for a variety of HI indications for the purpose of making ersodetug available on a compassionate use basis when available therapeutic options have failed, and an individual’s hypoglycemia is unmanageable. In clinical and real-world experience, ersodetug has been shown to counteract excessive insulin action downstream, at the insulin-receptor on target organs. The unique mechanism of action of ersodetug makes the therapy a potential universal treatment for any form of HI. To date, we have received over 30 unsolicited inbound physician inquiries regarding the use of ersodetug in patients with tumor HI caused by metastatic insulinomas or non-islet cell tumors, which has thus far resulted in the request, approval, and initiation of ersodetug in 15 ICT and NICT patients. In the U.S., these requests have all been individually approved by the FDA's Office of Cardiology, Hematology, Endocrinology and Nephrology - Division of Diabetes, Lipid Disorders, and Obesity (“Division”). The tumor HI patients that have received ersodetug have been refractory to SOC therapies for chronic management of hypoglycemia. These patients have generally required continuous intravenous dextrose or nutritional infusion in order to prevent severe hypoglycemia and were typically hospitalized and in life-threatening or hospice-bound condition at the time of request. Further treatment with tumor-directed therapies (e.g., embolization, radiotherapy, chemotherapy) was often deferred as a result of debilitating hypoglycemia.

Current wording

We maintain an expanded access program (“EAP”) for a variety of HI indications for the purpose of making ersodetug available on a compassionate use basis when patients have refractory hypoglycemia and cannot access a clinical trial. In clinical and real-world experience, ersodetug has been shown to counteract excessive insulin action downstream, at the insulin-receptor on target organs. The unique mechanism of action of ersodetug makes the therapy a potential universal treatment for any form of HI. To date, we have received numerous inbound physician inquiries regarding the use of ersodetug in patients with tumor HI caused by metastatic insulinomas or non-islet cell tumors, which led to compassionate use treatment in an expanded access program in more than a dozen patients. In the U.S., these requests have all been individually approved by the FDA’s Office of Cardiology, Hematology, Endocrinology and Nephrology - Division of Diabetes, Lipid Disorders, and Obesity. The tumor HI patients that have received ersodetug have been refractory to SOC therapies for chronic management of hypoglycemia. These patients have generally required continuous parenteral dextrose in order to prevent severe hypoglycemia and were typically hospitalized and in life-threatening or hospice-bound condition at the time of request. Further treatment with tumor-directed therapies (e.g., embolization, radiotherapy, chemotherapy) was often deferred as a result of debilitating hypoglycemia.

Previous wording

Generally, dosing for tumor HI patients has been either 6 mg/kg or 9 mg/kg every 1-4 weeks. Nearly universally, ersodetug has led to substantial reductions in GIR (equating to an improvement in hypoglycemia) and has been well tolerated. Within a relatively short period of time after administration of ersodetug, GIR was discontinued or substantially reduced, and hospitalized patients were able to be discharged and receive maintenance ersodetug doses on an outpatient basis, with durable benefit. In several cases, other background medical therapies to prevent hypoglycemia were able to be weaned or stopped, and patients were able to resume tumor-directed therapies for treatment of their underlying cancer. No participants have discontinued the therapy due to lack of response or safety, and the duration of treatment has ranged from several months to almost 2 years in some instances, in this subset of tumor HI patients with significantly advanced and metastatic tumor burden.

Current wording

Generally, dosing for tumor HI patients in the EAP has been either 6 mg/kg or 9 mg/kg every 1-4 weeks. Nearly universally, ersodetug has led to substantial reductions in GIR (equating to an improvement in hypoglycemia) and has been well tolerated. After initiation of ersodetug, GIR was discontinued or substantially reduced, and hospitalized patients were able to be discharged and receive maintenance ersodetug doses on an outpatient basis, with durable benefit. In several cases, other background medical therapies to prevent hypoglycemia were able to be weaned or stopped, and patients were able to resume tumor-directed therapies for treatment of their underlying cancer. No participants have discontinued the therapy due to lack of response or safety, and the duration of treatment has ranged from several months to almost 2 years in some instances, in this subset of tumor HI patients with significantly advanced and metastatic tumor burden.

Previous wording

Presented in a table filed on January 7, 2026, on Form 8-K with the U.S. Securities and Exchange Commission are cumulative data from the initial 9 participants in the EAP, including patient characteristics, ersodetug dosing, and observed outcomes. This same data cohort was provided to FDA last year in support of our request for Breakthrough Therapy Designation and subsequently informed the discussion with FDA that led to revision of the Phase 3 upLIFT study in tumor HI to a single arm, open-label study. In summary, 75% of the patients receiving IV dextrose/total parenteral nutrition (“TPN”) in the EAP achieved a complete discontinuation of IV dextrose/TPN.

Current wording

Presented in a table filed on January 7, 2026, on Form 8-K with the SEC are cumulative data from the initial 9 participants in the EAP, including patient characteristics, ersodetug dosing and observed outcomes. This same data cohort was provided to FDA last year in support of our request for Breakthrough Therapy Designation and subsequently informed the discussion with FDA that led to revision

Previous wording

Concurrent with the announcement on December 11, 2025 that our Phase 3 sunRIZE clinical trial did not meet its primary endpoint, management approved a reduction in workforce to conserve cash by reducing overall operating expenses based on our changing needs. We reduced our workforce by 29 employees on December 15, 2025. We incurred approximately $1.5 million of one-time severance expenses consisting of $0.9 million of research and development expense and $0.6 million in general and administrative expense in the three and six months ended December 31, 2025. All of the $1.5 million of one-time severance benefits is included as an accrued liability on the condensed consolidated balance sheet as of December 31, 2025 and included in operating expenses on the condensed consolidated statement of operations for the three and six months ended December 31, 2025. The accrued liability of $1.5 million was paid in full to the affected employees in January 2026 and no remaining liability related to the one-time severance benefits remain at the issuance date of the unaudited condensed consolidated financial statements.

Current wording

Concurrent with the announcement on December 11, 2025 that our Phase 3 sunRIZE clinical trial did not meet its primary endpoint, management approved a reduction in workforce to conserve cash by reducing overall operating expenses based on our changing needs. We reduced our workforce by 29 employees on December 15, 2025. We incurred $1.5 million of severance expenses in the second quarter of fiscal year 2026 consisting of $0.9 million of research and development expense and $0.6 million in general and administrative expense. Total severance benefits of $1.5 million were paid in full to the affected employees in January 2026 and no obligations related to the severance benefits remain as of March 31, 2026.

Previous wording

We have not generated any meaningful revenues since our inception in March 2010. Over the last several years, we have conducted private placements and public offerings to raise additional capital, adopted a licensing model to pursue development of product candidates, conducted pre-clinical and clinical trials, and conducted other research and development activities on our pipeline of product candidates.

Current wording

We have not generated any meaningful revenue since our inception in March 2010. Over the last several years, we have conducted private placements and public offerings to raise additional capital, adopted a licensing model to pursue development of product candidates, conducted pre-clinical and clinical trials, and conducted other research and development activities on our pipeline of product candidates.

Previous wording

compensation costs include an allocable portion of our cash and share-based compensation, employee benefits, and consulting costs related to personnel engaged in the design and development of product candidates and other scientific research projects. We also allocate a portion of our facilities and overhead costs based on the personnel and other resources devoted to R&D activities.

Current wording

Research and development expenses. Research and development (“R&D”) expenses consist primarily of cash and share-based compensation and employee benefits related to personnel engaged in R&D activities, clinical trial costs, licensing costs, and consulting and outside services engaged in the design and development of our product candidates and other scientific research projects. Our R&D costs also include an allocable portion of our facilities and overhead costs based on personnel and other resources devoted to R&D activities.

Previous wording

General and administrative expenses. General and administrative (“G&A”) expenses consist primarily of (i) an allocable portion of our cash and share-based compensation and employee benefits related to personnel engaged in our administrative, finance, accounting, and executive functions, and (ii) an allocable portion of our facilities and overhead costs related to such personnel. G&A expenses also include professional fees for business development, legal, auditing, consulting, investor relations and other costs primarily related to our status as a public company.

Current wording

General and administrative expenses. General and administrative (“G&A”) expenses consist primarily of cash and share-based compensation and employee benefits related to personnel engaged in our administrative, finance, accounting and executive functions. Our G&A expenses also include professional fees for business development, legal, auditing, consulting, investor relations, other costs primarily related to our status as a public company, and an allocable portion of our facilities and overhead costs based on personnel and other resources devoted to G&A activities.

Previous wording

With respect to our significant accounting policies that are described in Note 1 to our consolidated financial statements included in Item 8 of our 2025 Form 10-K, we believe that the following accounting policies involve a greater degree of judgment and complexity. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our consolidated financial condition and results of operations.

Current wording

With respect to our significant accounting policies that are described in Note 1 to our consolidated financial statements included in Item 8 of the 2025 Form 10-K, we believe that the following accounting policies involve a greater degree of judgment and complexity. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our consolidated financial condition and results of operations.

Previous wording

We measure the fair value of services received in exchange for grants of share-based awards based on the fair value of the award as of the grant date. We compute the fair value of the stock option awards with time-based vesting using the Black-Scholes-Merton option-pricing model and recognize the cost of the equity awards over the period that services are provided to earn the award. For stock option awards that contain a graded vesting schedule, and the only condition for vesting is a service condition, compensation cost is recognized on a straight-line basis over the requisite service period as if the award was, in substance, a single award. We recognize the impact of forfeitures in the period that the forfeiture occurs, rather than estimating the number of awards that are not expected to vest in accounting for share-based compensation. For stock options that are voluntarily surrendered, all unrecognized compensation is immediately recognized in the period the options are cancelled. Fair value of RSUs is based on the closing market price on the date of grant whereby compensation cost is recognized ratably over the vesting period of the RSUs.

Current wording

awards that contain a graded vesting schedule, and the only condition for vesting is a service condition, compensation cost is recognized on a straight-line basis over the requisite service period as if the award was, in substance, a single award. We recognize the impact of forfeitures in the period that the forfeiture occurs, rather than estimating the number of awards that are not expected to vest in accounting for share-based compensation. For stock options that are voluntarily surrendered, all unrecognized compensation is immediately recognized in the period the options are cancelled. Fair value of restricted stock units (“RSUs”) is based on the closing market price on the date of grant whereby compensation cost is recognized ratably over the vesting period of the RSUs.

Previous wording

Revenue. As a late-stage rare disease company, we did not generate any revenue for the three and six months ended December 31, 2025 and 2024. We are at a late stage of clinical development and do not currently have any commercial products. Our existing product candidates will require extensive additional clinical evaluation, regulatory review, significant marketing efforts and substantial investment before they generate any revenues. We do not expect to be able to generate revenue from any of our product candidates until we obtain regulatory approval and commercialize our approved product candidates.

Current wording

Revenue. As a late-stage rare disease company, we did not generate any revenue for the three and nine months ended March 31, 2026 and 2025. We are at a late stage of clinical development and do not currently have any commercial products. Our existing product candidates will require extensive additional clinical evaluation, regulatory review, significant marketing efforts and substantial investment before they generate any revenues. We do not expect to be able to generate revenue from any of our product candidates until we obtain regulatory approval and commercialize our approved product candidates.

Previous wording

The increase in total R&D expenses of $1.7 million for the three months ended December 31, 2025 was attributable to increases of $1.6 million in R&D compensation and benefits, one-time severance benefits of $0.9 million, and an increase of $0.8 million in other R&D costs related to quality and patient affairs costs related to the phase 3 clinical studies. These increases amount to $3.3 million and were partially offset by a decrease of $1.6 million related to ersodetug program costs.

Current wording

The decrease in R&D expenses of $3.9 million for the three months ended March 31, 2026 was attributable to a decrease of $3.9 million related to ersodetug program costs and a decrease of $0.3 million in other R&D costs related to preclinical and other pipeline development costs. These decreases amount to $4.2 million and were partially offset by an increase of $0.3 million in R&D compensation and benefits.

Previous wording

The $1.6 million decrease in ersodetug R&D costs was driven by a decrease of $2.9 million due to lower spending on drug substance and drug product manufacturing, including decreases in activity surrounding process performance qualification batch productions. This $2.9 million decrease was partially offset by (i) an increase of $1.0 million in clinical trial costs for our congenital HI phase 3 clinical study, which had 57 participants continuing on the open-label extension as of December 31, 2025, and (ii) an increase of $0.3 million in clinical costs due to startup activities in 2025, such as site activations, for the Phase 3 upLIFT study. For the three months ended December 31, 2024, there were de minimis clinical costs incurred for tumor HI related program spend as the Phase 3 upLIFT study had yet to be initiated and clinical costs for the Phase 3 sunRIZE study were lower as we did not complete enrollment of patients until May 2025.

Current wording

The $3.9 million decrease in ersodetug R&D costs was driven by (i) a decrease of $3.7 million due to the timing of drug substance and drug product manufacturing, including decreases in activity surrounding process performance qualification batch productions, (ii) a decrease of $0.1 million in clinical trial costs for the Phase 3 clinical sunRIZE study, which had 57 participants continuing on the open-label extension as of March 31, 2026, and (iii) a decrease of $0.1 million in clinical costs for the Phase 3 upLIFT study. For the three months ended March 31, 2025, there were higher clinical costs incurred for startup activities, such as site activations, for the tumor HI related program spend for the Phase 3 upLIFT study and clinical costs for the Phase 3 sunRIZE study were higher due to the ongoing enrollment of patients which fully enrolled in May 2025.

Previous wording

The $2.9 million increase in R&D compensation and benefit related costs was attributable to an increase of $1.6 million in cash-based compensation and benefits and an increase of $1.3 million in share-based compensation. The increase of $1.6 million in cash-based compensation was due to an increase in the average number of R&D employees from 44 for the six months ended December 31, 2024

Current wording

The $0.3 million increase in R&D compensation and benefits was attributable to an increase of $1.0 million in share-based compensation for stock options and RSUs granted, partially offset by a decrease of $0.7 million in cash-based compensation and benefits. The decrease of $0.7 million in cash-based compensation was due to a decrease in the average number of R&D employees from 48 for the three months ended March 31, 2025 to 36 employees for the three months ended March 31, 2026.

Previous wording

Interest and other income. Interest and other income amounted to $1.4 million for the three months ended December 31, 2025, compared to $1.3 million for the three months ended December 31, 2024. This increase of $0.1 million was primarily due to the higher average balance of investments in marketable debt securities throughout the three months ended December 31, 2025 compared to the three months ended December 31, 2024. The impact of higher investments in marketable debt securities was partially offset by lower yields in 2025 as the weighted average yield on interest-earning assets held by us decreased from 4.82% on December 31, 2024 to 4.06% on December 31, 2025.

Current wording

Interest and other income. Interest and other income amounted to $1.2 million for the three months ended March 31, 2026, compared to $1.1 million for the three months ended March 31, 2025. This increase of $0.1 million was primarily due to the higher average balance of investments in marketable debt securities for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. The impact of higher investments in marketable debt securities was partially offset by lower yields in 2026 as the weighted average yield on interest-earning assets held by us decreased from 4.7% on March 31, 2025 to 3.9% on March 31, 2026.

Previous wording

Income taxes. For the three months ended December 31, 2025 and 2024, we did not recognize any income tax benefit due to our net losses, and our determination that a valuation allowance was required for all of our deferred income tax assets.

Current wording

Income taxes. For the three months ended March 31, 2026 and 2025, we did not recognize any income tax benefit attributable to our net loss because a valuation allowance was required for our deferred income tax assets.

Previous wording

Research and development expenses. R&D expenses for the six months ended December 31, 2025 and 2024 were as follows (in thousands, except percentages):

Current wording

Research and development expenses. R&D expenses for the nine months ended March 31, 2026 and 2025 were as follows (in thousands, except percentages):

Previous wording

The increase in total R&D expenses of $2.1 million for the six months ended December 31, 2025 was attributable to increases of $2.9 million in R&D compensation and benefits, an increase of $1.5 million in other R&D costs related to quality and patient affairs costs related to the phase 3 clinical studies, and $0.9 million for one-time severance benefits. These increases amount to $5.3 million and were partially offset by a decrease of $3.2 million related to ersodetug program costs.

Current wording

The decrease in R&D expenses of $1.8 million for the nine months ended March 31, 2026 was attributable to a decrease of $7.1 million related to ersodetug program costs. This $7.1 million decrease was partially offset by (i) an increase of $3.2 million in R&D compensation and benefits, (ii) an increase of $1.2 million in other R&D costs related to quality and patient affairs costs related to the Phase 3 clinical studies, and (iii) an increase of $0.9 million for severance expense.

Previous wording

The $3.2 million decrease in ersodetug R&D costs was driven by a decrease of $6.0 million due to lower spending on drug substance and drug product manufacturing, including decreases in activity for process performance qualification batch productions. This $6.0 million decrease was partially offset by (i) an increase of $1.5 million in clinical trial costs for our congenital HI phase 3 clinical study, which had 57 participants continuing on the open-label extension as of December 31, 2025, and (ii) an increase of $1.3 million in clinical costs due to startup activities in 2025, such as site activations, related to the Phase 3 upLIFT study. For the six months ended December 31, 2024, there were de minimis clinical costs incurred for the Phase 3 upLIFT study had yet to be initiated and clinical costs for sunRIZE study were lower as we did not complete enrollment of patients until May 2025.

Current wording

The $7.1 million decrease in ersodetug R&D costs was driven by a decrease of $9.7 million due to lower spending on drug substance and drug product manufacturing, including decreases in activity for process performance qualification. This decrease of $9.7 million was partially offset by (i) an increase of $1.3 million in clinical trial costs for our congenital HI Phase 3 clinical study, which completed enrollment in May 2025, but still had 57 participants continuing on the open-label extension as of March 31, 2026, and (ii) an increase of $1.3 million in clinical costs due to startup activities, such as site activations, patient screenings and patient enrollment costs, related to the Phase 3 upLIFT study. For the nine months ended March 31, 2025, we had lower clinical costs incurred for the Phase 3 upLIFT study because startup costs did not commence until January 2025. In addition, clinical costs for the sunRIZE study were lower due to fewer patients that were active in the study in the comparative period.

Previous wording

The $1.6 million increase in R&D compensation and benefit related costs was attributable to an increase of $0.9 million in share-based compensation, and an increase of $0.7 million in cash-based compensation and benefits. The increase of $0.7 million in cash-based compensation was due to an increase in the average number of R&D employees from 46 for the three months ended December 31, 2024 to 51 employees for the three months ended December 31, 2025. The $0.9 million of one-time severance benefits related to employees who were terminated on December 15, 2025 in connection with a management implemented workforce reduction.

Current wording

The $3.2 million increase in R&D compensation and benefits was attributable to an increase of $2.3 million in share-based compensation and an increase of $0.9 million in cash-based compensation and benefits. The increase of $0.9 million in cash-based compensation was due to an increase in the average number of R&D employees from 45 for the nine months ended March 31, 2025 to 47 employees for the nine months ended March 31, 2026. The increase in severance expenses of $0.9 million was attributable to the 21 R&D employees who were terminated on December 15, 2025 in connection with a management implemented workforce reduction.

Previous wording

General and administrative expenses. G&A expenses for the six months ended December 31, 2025 and 2024 were as follows (in thousands, except percentages):

Current wording

General and administrative expenses. G&A expenses for the nine months ended March 31, 2026 and 2025 were as follows (in thousands, except percentages):

Previous wording

The increase in total G&A expenses of $5.4 million for the three months ended December 31, 2025 was attributable to an increase of $3.1 million in other G&A costs related to business development and market research and planning activities in preparation for future ersodetug commercial activities, an increase of $1.7 million in G&A compensation and benefits, and one-time severance benefits of $0.6 million.

Current wording

The increase in G&A expenses of $9.1 million for the nine months ended March 31, 2026 was attributable to an increase of $4.4 million in G&A compensation and benefits, an increase of $4.2 million in other G&A costs related to business development and market research and planning activities in preparation for future ersodetug commercial activities, and an increase in severance expense of $0.5 million.

Previous wording

The $1.7 million increase in G&A compensation and benefit related costs was attributable to an increase of $1.1 million in share-based compensation and an increase of $0.6 million in cash-based compensation and benefits. The increase of $0.6 million in cash-based compensation was due to an increase in the average number of G&A employees from 18 for the three months ended December 31, 2024 to 24 employees for the three months ended December 31, 2025. The $0.6 million of one-time severance benefits related to employees who were terminated on December 15, 2025 in connection with a management implemented workforce reduction.

Current wording

The $4.4 million increase in G&A compensation and benefits was attributable to an increase of $3.3 million in share-based compensation and an increase of $1.1 million in cash-based compensation and benefits. The increase of $1.1 million in cash-based compensation was due to an increase in the average number of G&A employees from 18 for the nine months ended March 31, 2025 to 21 employees for the nine months ended March 31, 2026. There was $0.6 million of severance expense recognized in December 2025 related to the 8 G&A employees who were terminated on December 15, 2025 in connection with a management implemented workforce reduction, compared to $0.1 million of severance expense recognized in the nine months ended March 31, 2025.

Previous wording

Interest and other income. Interest and other income amounted to $3.1 million for the six months ended December 31, 2025, compared to $2.9 million for the six months ended December 31, 2024. This increase of $0.2 million was primarily due to the higher average balance of investments in marketable debt securities throughout the six months ended December 31, 2025 compared to the six months ended December 31, 2024. The impact of higher investments in marketable debt securities was partially offset by lower yields in 2025 as the weighted average yield on interest-earning assets held by us decreased from 4.82% on December 31, 2024 to 4.06% on December 31, 2025.

Current wording

Interest and other income. Interest and other income amounted to $4.3 million for the nine months ended March 31, 2026, compared to $4.0 million for the nine months ended March 31, 2025. This increase of $0.3 million was primarily due to the higher average balance of investments in marketable debt securities for the nine months ended March 31, 2026 compared to the nine months ended March 31, 2025. The impact of higher investments in marketable debt securities was partially offset by lower yields in 2026 as the weighted average yield on interest-earning assets held by us decreased from 4.7% on March 31, 2025 to 3.9% on March 31, 2026.

Previous wording

Income taxes. For the six months ended December 31, 2025 and 2024, we did not recognize any income tax benefit due to our net losses, and our determination that a valuation allowance was required for all of our deferred income tax assets.

Current wording

Income taxes. For the nine months ended March 31, 2026 and 2025, we did not recognize any income tax benefit attributable to our net loss because a valuation allowance was required for our deferred income tax assets.

Previous wording

As of December 31, 2025, we had cash and cash equivalents of $11.9 million and short-term marketable debt securities of $121.0 million for total capital resources of $132.9 million. Working capital amounted to approximately $125.6 million as of December 31, 2025. We have incurred cumulative net losses of $444.8 million since our inception and as a clinical stage company we have not generated any meaningful revenue to date.

Current wording

As of March 31, 2026, we had cash and cash equivalents of $11.2 million and short-term marketable debt securities of $109.0 million for total capital resources of $120.2 million. Working capital amounted to approximately $114.3 million as of March 31, 2026. We have incurred cumulative net losses of $461.0 million since our inception and as a clinical stage company we have not generated any meaningful revenue to date.

Previous wording

Accordingly, our primary source of liquidity has historically been from the completion of private placements and public offerings of our equity securities. The completion of equity financings between June 2024 and June 2025 is the primary source of our cash, cash equivalents and short-term investments in marketable debt securities totaling $132.9 million as of December 31, 2025.

Current wording

Our primary source of liquidity has historically been from the completion of private placements and public offerings of our equity securities. The completion of equity financings between June 2024 and June 2025 is the primary source of our cash, cash equivalents and short-term investments in marketable debt securities totaling $120.2 million as of March 31, 2026.

Previous wording

Expected cash payments related to existing contractual obligations for the 12-months ending December 31, 2026 include approximately (i) $0.8 million under all of our operating lease agreements, and (ii) $1.5 million in one-time severance benefits due to employees

Current wording

Expected cash payments related to existing contractual obligations for the 12-months ending March 31, 2027 include approximately $0.8 million under our operating lease agreements.

Previous wording

Based on our cash, cash equivalents and investments in marketable debt securities totaling $132.9 million as of December 31, 2025, we believe we have adequate capital resources to meet our contractual obligations and carry out ongoing clinical trials and other planned activities for at least 12 months from the issuance date of the unaudited condensed consolidated financial statements as of December 31, 2025.

Current wording

Based on our cash, cash equivalents and investments in marketable debt securities totaling $120.2 million as of March 31, 2026, we believe we have adequate capital resources to meet our contractual obligations and carry out ongoing clinical trials and other planned activities for at least 12 months from the issuance date of the unaudited condensed consolidated financial statements as of March 31, 2026.

Previous wording

In addition to our licensing obligations, we also have approximately $0.8 million of long-term contractual obligations under existing operating lease agreements that expire by October 2027.

Current wording

In addition to our licensing obligations, we also have approximately $0.4 million of long-term contractual obligations under existing operating lease agreements that expire by October 2027.

Previous wording

To date we have paid a total of $12.0 million in milestone payments to XOMA. The most recent milestone payment of $5.0 became due in May 2025 upon dosing of the last patient in our Phase 3 clinical trial for ersodetug and was paid in June 2025. The next milestone payment of $25.0 million will be due upon regulatory approval for ersodetug by any regulatory authority. We record a liability for milestone payments in our financial statements on the date that we achieve the milestone event. Additionally, upon the future commercialization of ersodetug, we will be required to pay royalties to XOMA based on the net sales of the related products, and milestone payments up to an additional $185.0 million if future annual sales related to ersodetug exceed targets ranging from $100.0 million to $1.0 billion. Through December 31, 2025, no events have occurred that would result in the requirement to make additional milestone payments, and no royalties have been incurred to date.

Current wording

To date we have paid a total of $12.0 million in milestone payments to XOMA. The most recent milestone payment of $5.0 million became due in May 2025 upon dosing of the last patient in our Phase 3 clinical trial for ersodetug and was paid in June 2025. The next milestone payment of $25.0 million will be due upon regulatory approval for ersodetug by any regulatory authority. We record a liability for milestone payments in our financial statements on the date that we achieve the milestone event. Additionally, upon the future commercialization of ersodetug, we will be required to pay royalties to XOMA based on the net sales of the related products, and milestone payments up to an additional $185.0 million if future annual net sales related to ersodetug exceed targets ranging from $100.0 million to $1.0 billion. Through March 31, 2026, no events have occurred that would result in the requirement to make additional milestone payments, and no royalties have been incurred to date.