Rezolute, Inc.

Previous 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.

Current wording

We are a late-stage rare disease company focused on developing therapies that treat refractory and debilitating hypoglycemia associated with various forms of hyperinsulinism (“HI”).

Previous 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.

Current wording

Our priorities for the remainder of 2026 and first half of 2027 are to: (i) announce topline data for the registrational Phase 3 upLIFT study in tumor HI, (ii) complete a pre-Biologics License Application meeting with the U.S. Food and Drug Administration (the “FDA” or the “Agency”), and (iii) submit a Biologics License Application (“BLA”) to the FDA for ersodetug for one or both programs in mid-2027.

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. Although statistical significance for the secondary endpoint (% time in hypoglycemia by continuous glucose monitoring [“CGM”]) was not achieved at the Week 24/End of Treatment evaluation window, larger and often nominally statistically significant glycemic improvements compared to placebo were consistently observed throughout the maintenance dosing phase of the study, across time and numerous pre-specified and post-hoc CGM-based endpoints.

Current wording

On December 11, 2025, we announced that the sunRIZE study did not meet its primary endpoint (hypoglycemia events by finger stick self-monitored blood glucose “SMBG”) or its key secondary endpoint (time in hypoglycemia by continuous glucose monitoring “CGM”) at the defined Week 24 evaluable window. Although statistical significance for the secondary endpoint was not achieved at the Week 24/End of Treatment evaluation window, larger and often nominally statistically significant reductions in hypoglycemia compared to placebo were consistently observed throughout the maintenance dosing phase of the study, across time and numerous pre-specified and post-hoc CGM-based endpoints. 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 reduced cellular glucose transport and an increase in blood glucose.

Previous wording

We met with FDA on March 17, 2026, under our Breakthrough Therapy Designation to discuss next steps for this indication. During the meeting, we presented summary results from sunRIZE including: (i) information to support our belief that the primary endpoint was confounded as a result of behavioral factors; (ii) evidence of pharmacologic activity; (iii) consistent improvements compared to placebo in time in hypoglycemia and a variety of other CGM-based glycemic endpoints, as discussed above; and (iv) preliminary favorable observations from the ongoing open-label extension (“OLE”).

Current wording

We met with the FDA on March 17, 2026, under our Breakthrough Therapy Designation to discuss next steps for this indication. During the meeting, we presented summary results from sunRIZE including: (i) information to support our belief that the primary endpoint was confounded as a result of behavioral factors; (ii) evidence of pharmacologic activity; (iii) consistent improvements compared to placebo in time in hypoglycemia and a variety of other CGM-based glycemic endpoints, as discussed above; and (iv) preliminary favorable observations from the ongoing open-label extension (“OLE”). At the meeting the Agency acknowledged the challenges posed by behavioral factors in clinical trials in this patient population, including limitations associated with SMBG based measures of hypoglycemia. The Agency requested that the Company provide the continuous CGM data for its independent review. In June 2026, the Company submitted source and analysis datasets, and summary results from a substantial number of pre-specified, post-hoc, and sensitivity analyses.

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 (“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.

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 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 2,000 individuals.

Previous wording

Ersodetug has received Orphan Drug Designation in the U.S. and European Union for the treatment of congenital HI, as well as Rare Pediatric Disease Designation in the U.S., a prerequisite for a request for a Rare Pediatric Disease Priority Review Voucher upon Biologics License Application (BLA) submission. Based on the multinational Phase 2b clinical trial outcomes and the evidence of benefit in this serious condition with substantial unmet medical need, ersodetug was subsequently granted a priority medicines (PRIME) designation by the European Medicines Agency (EMA), an Innovation Passport designation by the UK Innovative Licensing and Access Pathway (ILAP) Steering Group for the treatment of congenital HI, and Breakthrough Therapy Designation by the FDA in the U.S.

Current wording

Ersodetug has received Orphan Drug Designation in the U.S. and European Union for the treatment of congenital HI, as well as Rare Pediatric Disease Designation in the U.S., a prerequisite for a request for a Rare Pediatric Disease Priority Review Voucher upon BLA submission. Based on the multinational Phase 2b (RIZE) clinical trial outcomes and the evidence of benefit in this serious condition with substantial unmet medical need, ersodetug was subsequently granted a priority medicines (PRIME) designation by the European Medicines Agency (EMA), an Innovation Passport designation by the UK Innovative Licensing and Access Pathway (ILAP) Steering Group for the treatment of congenital HI, and Breakthrough Therapy Designation by the FDA in the U.S.

Previous 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.

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 study is now fully enrolled and topline data is expected in mid-December 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 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.

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 CGM, respectively, and patient reported quality of life.

Previous wording

Based on historical precedent, supportive data from the sunRIZE study (i.e., safety and drug activity), the recent liberalization of the tumor HI study and differentiation between study endpoints, and the experience that we have reported in the historical Expanded Access Program, we remain cautiously optimistic regarding the probability of success in this indication; however, there can be no assurance that FDA will not consider the sunRIZE study’s failure to meet its endpoints in assessing the approvability of tumor HI. We will continue to engage with FDA on this topic.

Current wording

Based on historical precedent, supportive data from the sunRIZE study (i.e., safety and drug activity), the recent liberalization of the tumor HI study and differentiation between study endpoints, and the experience that we have reported in the historical Expanded Access Program, we remain cautiously optimistic regarding the probability of success in this indication.

Previous wording

While we believe the total addressable market may be larger, the immediately addressable incidence market for the combined indications causing tumor HI is estimated to be approximately 3,000 patients in the U.S. alone per year. We believe 60% of these patients are managed at the National Cancer Institutes, which will be our primary focus at launch.

Current wording

While we believe the total addressable market may be larger, the immediately addressable incidence market for the combined indications causing tumor HI is estimated to be approximately 4,000 patients in the U.S. alone per year. We believe 60% of these patients are managed at the National Cancer Institutes and academic medical centers, which will be our primary focus at launch.

Previous 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.

Current wording

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 more than 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 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

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 of the 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.

Previous wording

Six patients with congenital HI are currently receiving ersodetug as part of our EAP, which has served to support patients on a compassionate use basis prior to availability of the Phase 3 sunRIZE clinical trial. These participants were refractory to usual therapies and include one infant where off-label or surgical (pancreatectomy) therapies were being considered. The duration of treatment in these participants ranges from more than a year to more than 3 years, with ongoing benefit.

Current wording

We also maintain an EAP for patients with congenital and other forms of hyperinsulinism, which has served to provide access on a compassionate use basis, to patients who do not qualify or otherwise cannot participate in a clinical trial of ersodetug. This includes several congenital HI participants who were refractory to usual therapies and one infant where off-label or surgical (pancreatectomy) intervention was being considered as the only remaining option, but was averted by use of ersodetug in the EAP. The duration of treatment in these participants ranges from more than a year to more than 4 years, with ongoing benefit.

Previous 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.

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

Previous wording

Interest and other income. Interest and other income consist primarily of interest income earned on marketable debt securities and temporary cash investments, amortization of investment premiums and accretion of investment discounts, and realized gains on investments in marketable debt securities.

Current wording

Interest and other income. Interest and other income consist primarily of interest income earned on marketable debt securities and temporary cash investments, amortization of investment premiums and accretion of investment discounts.

Previous wording

Loss from change in fair value of derivative liabilities. We recognize liabilities for financial instruments that are required to be accounted for as derivatives, as well as embedded derivatives in our debt agreements. Derivative liabilities are adjusted to fair value at the end of each reporting period until the contracts are settled, expire or otherwise meet the conditions for equity classification. Changes in fair value are reflected as a gain or loss in our unaudited condensed consolidated statements of operations and comprehensive loss.

Current wording

Loss from change in fair value of embedded derivative liabilities. We recognize liabilities for financial instruments that are required to be accounted for as derivatives, including embedded derivatives in our debt agreements. Derivative liabilities are adjusted to fair value at the end of each reporting period until the contracts are settled, expire or otherwise meet the conditions for equity classification. Changes in fair value are reflected as a gain or loss in our unaudited condensed consolidated statements of operations and comprehensive loss.

Previous wording

R&D costs are expensed as incurred. Intangible assets related to in-licensing costs under license agreements with third parties are charged to expense unless we are able to determine that the licensing rights have an alternative future use.

Current wording

R&D costs are expensed as incurred. Intangible assets related to in-licensing costs under license agreements with third parties are charged to expense unless we are able to determine that the licensing rights have an alternative future use in other research and development projects or otherwise.

Previous wording

Clinical trial costs are a component of R&D expenses. We accrue and recognize expenses for clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with clinical research organizations and clinical trial sites. We determine the estimates through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Nonrefundable advance payments for goods and services that will be used or rendered in future R&D activities are deferred and recognized as expense in the period that the related goods are delivered, or services are performed.

Current wording

Clinical trial costs are a component of R&D expenses. We accrue and recognize expenses for clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with clinical research organizations and clinical trial sites. We determine the estimates through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services.

Previous 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.

Current 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 stock options with time-based vesting using the Black-Scholes Merton (“BSM”) 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. Fair value of RSUs is based on the closing market price on the date of grant whereby compensation costs are recognized on a straight-line basis 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 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.

Current wording

Revenue. As a late-stage rare disease company, we did not generate any revenue for the three months ended September 30, 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 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.

Current wording

The decrease in R&D expenses of $0.3 million for the three months ended September 30, 2026 was attributable to a decrease of $0.2 million in other R&D costs related to preclinical and other patient affairs costs, and a decrease of $0.1 million related to ersodetug program costs.

Previous 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.

Current wording

The $0.1 million decrease in ersodetug R&D costs was driven by (i) a decrease of $0.4 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 56 participants continuing on the open-label extension as of September 30, 2026. These decreases were offset by an increase of $0.4 million in clinical costs for the Phase 3 upLIFT study. For the three months ended September 30, 2025, there were lower clinical costs incurred for startup activities, such as site activations, for the tumor HI related Phase 3 upLIFT study and clinical costs for the Phase 3 sunRIZE study were higher due to patients’ participation in the study compared to exclusively OLE participation in the three months ended September 30, 2026.

Previous wording

The increase in G&A expenses of $1.2 million for the three months ended March 31, 2026 was attributable to an increase of $1.6 million in G&A compensation and benefits, partially offset by a decrease of $0.4 million in other G&A costs. The $1.6 million increase in G&A compensation and benefits was attributable to an increase of $1.5 million in share-based compensation and an increase of $0.1 million in cash-based compensation and benefits for market adjustments.

Current wording

The decrease in G&A expenses of $0.1 million for the three months ended September 30, 2026 was attributable to a decrease of $0.4 million in other G&A costs, partially offset by an increase of $0.3 million in G&A compensation and benefits.

Previous wording

The decrease of $0.4 million in other G&A costs was due to pausing certain business development, market research and planning activities in preparation for future ersodetug commercial activities to allow for continued discussions with the FDA regarding the sunRIZE topline results.

Current wording

The decrease of $0.4 million in other G&A costs was primarily due to a $0.3 million decrease related to the deferred financing costs for the open market sales agreement with Jefferies that was terminated in the prior fiscal year and expensed in the three months ended September 30, 2025, and a $0.1 million decrease in certain business development, market research and planning activities in preparation for future ersodetug commercial activities for the three months ended September 30, 2026 when compared to the three months ended September 30, 2025.

Previous 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.

Current wording

The $0.3 million increase in G&A compensation and benefits was attributable to an increase of $0.4 million in share-based compensation offset by a decrease of $0.1 million in cash-based compensation and benefits due to a decrease in the average number of G&A employees, from 21 for the three months ended September 30, 2025 to 18 employees for the three months ended September 30, 2026.

Previous 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.

Current wording

Interest and other income. Interest and other income amounted to $0.9 million for the three months ended September 30, 2026, compared to $1.7 million for the three months ended September 30, 2025. This decrease of $0.8 million was primarily due to the lower average balance of investments in marketable debt securities for the three months ended September 30, 2026 compared to the three months ended September 30, 2025.

Previous 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.

Current wording

As of September 30, 2026, our capital resources consist of cash and cash equivalents of $8.2 million and short-term marketable debt securities of $81.8 million. Working capital amounted to approximately $84.4 million as of September 30, 2026. We have incurred cumulative net losses of $499.9 million since our inception and as a clinical stage company we have not generated any meaningful revenue to date.

Previous 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.

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 April 2025 and June 2025 is the primary source of our cash, cash equivalents and short-term investments in marketable debt securities totaling $90.0 million as of September 30, 2026.

Previous 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.

Current wording

Expected cash payments related to existing contractual obligations for the 12-month period ending September 30, 2027 include approximately $0.7 million under our operating lease agreements.

Previous 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.

Current wording

Based on our cash, cash equivalents and investments in marketable debt securities totaling $90.0 million as of September 30, 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 September 30, 2026.

Previous wording

Our most significant long-term contractual obligations consist of a regulatory milestone payment of $25.0 million payable to XOMA and additional clinical and regulatory milestone payments up to $25.0 million payable to ActiveSite. Due to uncertainties in the timing associated with clinical trial activities and regulatory approvals, there is even greater uncertainty in forecasting the timing of our long-term future clinical and regulatory milestone payments to XOMA and ActiveSite.

Current wording

Our most significant long-term contractual obligations consist of the regulatory milestone payment of $25.0 million payable to Ligand and additional clinical and regulatory milestone payments up to $25.0 million payable to ActiveSite. Due to uncertainties in the timing associated with clinical trial activities and regulatory approvals, there is even greater uncertainty in forecasting the timing of our long-term future clinical and regulatory milestone payments to Ligand and ActiveSite.

Previous wording

In addition to the clinical and regulatory milestone payments discussed above, upon the future commercialization of ersodetug and compounds from our PKI Portfolio (as defined below) we will be obligated to pay additional milestone payments and alternative indication regulatory approval payments to XOMA and ActiveSite for an aggregate up to $202.5 million and royalties based on the net sales of the related products. These future milestones include $185.0 million in potential payments to XOMA and $17.5 million to ActiveSite for various sales-based milestones and alternative indication regulatory approvals. No assurance can be provided that commercialization will ever be achieved for ersodetug or compounds from our PKI Portfolio, in which case none of these future payments may ever be required.

Current wording

In addition to the clinical and regulatory milestone payments discussed above, upon the future commercialization of ersodetug and compounds from our PKI Portfolio (as defined below) we will be obligated to pay additional milestone payments and alternative indication regulatory approval payments to Ligand and ActiveSite for an aggregate up to $202.5 million and royalties based on the net sales of the related products. These future milestones include $185.0 million in potential payments to Ligand and $17.5 million to ActiveSite for various sales-based milestones and alternative indication regulatory approvals. No assurance can be provided that commercialization will ever be achieved for ersodetug or compounds from our PKI Portfolio, in which case none of these future payments may ever be required.

Previous 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.

Current wording

In addition to our licensing obligations, we may be required to pay a $1.0 million Success Fee from our consulting agreement discussed above and have approximately $0.1 million of long-term contractual obligations under existing operating lease agreements that expire by October 2027.

Previous wording

Presented below is further discussion about the ongoing requirements pursuant to our license agreements with XOMA and ActiveSite, along with additional information about our ongoing financing activities that impacted our liquidity and capital resources through March 31, 2026.

Current wording

Presented below is further discussion about the ongoing requirements pursuant to our license agreements with Ligand and ActiveSite, along with additional information about our cash flow activity that impacted our liquidity and capital resources through September 30, 2026.

Previous wording

In December 2017, we entered into a license agreement (the “XOMA License Agreement”) with XOMA through its wholly-owned subsidiary, XOMA (US) LLC, pursuant to which XOMA granted an exclusive global license to develop and commercialize XOMA 358 (formerly X358 or RZ358, now ersodetug) for all indications. In January 2019, the XOMA License Agreement was amended with an updated payment schedule, as well as revised the amount we were required to expend on development of ersodetug and related licensed products, and revised provisions with respect to our diligence efforts in conducting clinical studies.

Current wording

In December 2017, we entered into a license agreement (the “Ersodetug License Agreement”) with XOMA through its wholly-owned subsidiary, XOMA (U.S.) LLC, pursuant to which XOMA granted an exclusive global license to develop and commercialize ersodetug for all indications. On July 14, 2026, XOMA was acquired by Ligand Pharmaceuticals Incorporated (“Ligand”).

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 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.

Current wording

To date we have paid a total of $12.0 million in milestone payments pursuant to the Ersodetug License Agreement. 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 Ligand based on the net sales of the related products, and milestone payments up to an additional $185.0 million if future net sales related to ersodetug exceed annual targets ranging from $100.0 million to $1.0 billion. Through September 30, 2026, no events have occurred that would result in a requirement to make additional milestone payments, and no royalties have been incurred to date.

Previous wording

In August 2017, we entered into a Development and License Agreement (the “ActiveSite License Agreement”) with ActiveSite Pharmaceuticals, Inc. (“ActiveSite”) pursuant to which we acquired the rights to ActiveSite’s Plasma Kallikrein Inhibitor program (“PKI Portfolio”). We initially focused on the development of RZ402 as a therapy for diabetic macular edema (“DME”). Following the completion of a Phase 2 clinical study for RZ402, we decided to pause the program to focus its resources on ersodetug. We are currently exploring the use of the PKI Portfolio to develop therapies for different indications. To date we have paid a total of $4.0 million in milestone payments to ActiveSite. The most recent milestone payment of $3.0 million was in February 2023 after dosing the first patient in a Phase 2 clinical trial for RZ402. The next milestone payment of $5.0 million will be due upon dosing of the first patient in a Phase 3 clinical trial. Remaining milestone payments under the ActiveSite License Agreement for various clinical and regulatory milestones amount to $25.0 million and milestones after commercial success or alternative indication approvals amount to $17.5 million. We will also be required to pay royalties equal to 2.0% of any net sales of products that use the PKI Program. 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.

Current wording

In August 2017, we entered into a Development and License Agreement (the “ActiveSite License Agreement”) with ActiveSite Pharmaceuticals, Inc. (“ActiveSite”) pursuant to which we acquired the rights to ActiveSite’s Plasma Kallikrein Inhibitor program (“PKI Portfolio”). We initially focused on the development of RZ402 as a therapy for diabetic macular edema (“DME”). Following the completion of a Phase 2 clinical study for RZ402, we decided to pause the program to focus our resources on ersodetug. We are currently exploring the use of the PKI Portfolio to develop therapies for different indications. To date we have paid a total of $4.0 million in milestone payments to ActiveSite. The most recent milestone payment of $3.0 million was in February 2023 after dosing the first patient in a Phase 2 clinical trial for RZ402. The next milestone payment of $5.0 million will be due upon dosing of the first patient in a Phase 3 clinical trial. Remaining milestone payments under the ActiveSite License Agreement for various clinical and regulatory milestones amount to $25.0 million and milestones after commercial success or alternative indication approvals amount to $17.5 million. We will also be required to pay royalties equal to 2.0% of any net sales of products that use the PKI Portfolio. Through September 30, 2026, no events have occurred that would result in the requirement to make additional milestone payments, and no royalties have been incurred to date.

Previous wording

Presented below is a summary of our operating, investing, and financing cash flows for the nine months ended March 31, 2026 and 2025 (in thousands):

Current wording

Presented below is a summary of our operating, investing, and financing cash flows for the three months ended September 30, 2026 and 2025 (in thousands):

Previous wording

For the nine months ended March 31, 2026 and 2025, cash used in operating activities amounted to $51.5 million and $47.1 million, respectively. The key components in the calculation of our cash used in operating activities are as follows (in thousands):

Current wording

For the three months ended September 30, 2026 and 2025, cash used in operating activities amounted to $18.8 million and $17.4 million, respectively. The key components in the calculation of our cash used in operating activities are as follows (in thousands):

Previous wording

For the nine months ended March 31, 2026, our net loss was $57.1 million compared to $50.0 million for the nine months ended March 31, 2025. For further discussion about changes in our operating results for the nine months ended March 31, 2026 and 2025, please refer toResults of Operations above.

Current wording

For the three months ended September 30, 2026, our net loss was $18.5 million compared to $18.2 million for the three months ended September 30, 2025. For further discussion about changes in our operating results for the three months ended September 30, 2026 and 2025, please refer toResults of Operations above.