Rezolute, Inc.

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 Food and Drug Administration (“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 addressable market for congenital HI is more than 1,500 individuals.

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 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.

Previous wording

The upLIFT study is a Phase 3 registrational, single-arm, open-label, pivotal trial in as few as 16 participants with tumors who have uncontrolled hypoglycemia caused by tumor HI. Eligible participants requiring continuous intravenous (“IV”) glucose 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. The primary endpoint is the number of participants achieving at least a 50 percent reduction from baseline in IV glucose requirements (glucose infusion rate; “GIR”). 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 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.

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 25 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 13 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 the standard of care 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 the debilitating hypoglycemia.

Current 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.

Previous wording

Generally, dosing for tumor HI patients has been either 6 mg/kg or 9 mg/kg every 1-4 weeks. In all cases to date, ersodetug has led to substantial improvement in hypoglycemia and has been well tolerated. Within a relatively short period of time after administration of ersodetug, continuous intravenous dextrose 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 one year in several instances, in this subset of tumor HI patients with significantly advanced and metastatic tumor burden.

Current 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.

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 one to approximately 3 years, with ongoing benefit.

Current 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.

Previous wording

Tumor HI may be caused by two distinct types of solid tumors: neuroendocrine islet cell tumors (“ICTs”) and non-islet cell tumors (“NICTs”), both of which lead to hypoglycemia due to excessive activation of the insulin receptor. Insulinomas are the most common type of functional ICT and mediate hypoglycemia through excessive insulin production. NICTs are generally associated with relatively large, solid tumors such as hepatocellular carcinoma, fibrosarcoma and mesothelioma, and can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances such as IGF-2 or related variants that bind to and activate the insulin receptor. This form of hypoglycemia can occur in more than 15 different tumor types.

Current wording

Tumor HI may be caused by two distinct types of solid tumors: neuroendocrine islet cell tumors (“ICTs”) and non-islet cell tumors (“NICTs”), both of which lead to hypoglycemia due to excessive activation of the insulin receptor. Insulinomas are the most common type of functional ICT and mediate hypoglycemia through excessive insulin production. NICTs are generally associated with relatively large, solid tumors such as hepatocellular carcinoma, fibrosarcoma and mesothelioma, and can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances such as IGF-2 or related variants that bind to and activate the insulin receptor. This form of hypoglycemia can occur in more than 15 different types of tumors.

Previous 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 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

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

While we believe the total addressable market may be larger, the immediately addressable market for the combined indications causing tumor HI is estimated to be approximately 1,500 patients in the U.S. alone.

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 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.

Previous wording

Research and development expenses. Research and development (“R&D”) expenses consist primarily of compensation and benefits for our personnel engaged in R&D activities, clinical trial costs, licensing costs, and consulting and outside services. Our R&D 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

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.

Previous wording

We account for investments in marketable debt securities as available-for-sale securities whereby they are recorded in our consolidated balance sheets at fair value. Interest income consists of accrued interest earned based on the coupon rate of the security, plus the impact of accreting discounts and amortizing premiums to maturity using the straight-line method which approximates the interest method. Unrealized gains and losses due to subsequent changes in fair value of the investments are reported in shareholders’ equity as a component of accumulated other comprehensive income (loss). The individual debt securities in our portfolio are subject to credit risk in the event of default by the issuers. We review the components of our portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below amortized cost have resulted from a credit-related loss or other factors. To the extent that declines in fair value are due to a deterioration of credit quality of the issuer, we will recognize an allowance for credit losses related to such investments with a corresponding loss in the consolidated statements of operations. Allowances for credit losses may be reversed in subsequent periods if conditions improve and credit-related losses are no longer

Current wording

We account for investments in marketable debt securities as available-for-sale securities whereby they are recorded in our consolidated balance sheets at fair value. Interest income consists of accrued interest earned based on the coupon rate of the security, plus the impact of accreting discounts and amortizing premiums to maturity using the straight-line method which approximates the interest method. Unrealized gains and losses due to subsequent changes in fair value of the investments are reported in shareholders’ equity as a component of accumulated other comprehensive income (loss). The individual debt securities in our portfolio are subject to credit risk in the event of default by the issuers. We review the components of our portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below amortized cost have resulted from a credit-related loss or other factors. To the extent that declines in fair value are due to a deterioration of credit quality of the issuer, we will recognize an allowance for credit losses related to such investments with a corresponding loss in the consolidated statements of operations. Allowances for credit losses may be reversed in subsequent periods if conditions improve and credit-related losses are no longer expected. For a decline in fair value that is solely due to changes in interest rates, impairment is not recognized if we have the ability and intent to hold the investment until maturity. The cost basis of any securities sold prior to maturity will be determined using the specific identification method.

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 in other R&D projects or otherwise.

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.

Previous wording

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

Previous wording

The increase in R&D expenses of $0.4 million for the three months ended September 30, 2025 was attributable to increases of $1.3 million in R&D compensation and benefits, and an increase of $0.7 million in other R&D costs related to quality and patient affairs costs related to the phase 3 clinical study. These increases amount to $2.0 million and were partially offset by a decrease of $1.6 million related to ersodetug clinical and manufacturing costs.

Current 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.

Previous wording

The increase in R&D compensation and benefit related costs of $1.3 million was attributable to (i) an increase of $0.8 million cash-based compensation and benefits due to an increase in the average number of R&D employees from 41 for the three months ended September 30, 2024 to 54 employees for the three months ended September 30, 2025, and (ii) an increase of $0.5 million in share-based compensation related to the stock awards granted in the first half of calendar 2025.

Current 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.

Previous wording

The $1.6 million decrease in ersodetug R&D costs was driven by a decrease of $3.0 million due to lower spending on drug substance and drug product manufacturing, as well as process performance qualification batch productions. This $3.0 million decrease was partially offset by (i) an increase of $1.0 million in clinical costs due to startup activities in 2025 for the tumor HI phase 3 study which we are in preparation for first patient enrollment anticipated in the fourth quarter of calendar 2025, and (ii) an increase of $0.4 million in clinical trial costs due to the completion of enrollment of patients in the congenital HI phase 3 clinical study in May 2025. For the three months ended September 30, 2024, there were de minimis clinical costs incurred for tumor HI related program spend as this study had yet to be initiated and clinical costs for congenital HI were lower because we had not completed enrollment of patients in the sunRIZE study as of September 30, 2024.

Current 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.

Previous wording

The increase in G&A expenses of $2.5 million for the three months ended September 30, 2025 was attributable to (i) an increase of $1.1 million in G&A compensation and benefits, and (ii) an increase of $1.4 million in other G&A costs related to business development and market research and planning activities in preparation for future ersodetug commercial activities.

Current 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.

Previous wording

The increase in G&A compensation and benefit related costs of $1.1 million was attributable to (i) an increase of $0.4 million for cash-based compensation and benefits due to an increase in the average number of G&A employees from 18 for the three months ended September 30, 2024 to 21 employees for the three months ended September 30, 2025, and (ii) an increase of $0.7 million in share-based compensation related to the stock awards granted in the first half of calendar 2025.

Current 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.

Previous wording

Interest and other income. Interest and other income amounted to $1.7 million for the three months ended September 30, 2025, compared to $1.6 million for the three months ended September 30, 2024. This increase of $0.1 million was primarily due to the Company having a higher average balance of investments in marketable debt securities throughout the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

Current 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.

Previous wording

As of September 30, 2025, we had cash and cash equivalents of $9.1 million and short-term marketable debt securities of $143.1 million for total capital resources of $152.2 million. Working capital amounted to approximately $144.5 million as of September 30, 2025. We have incurred cumulative net losses of $422.0 million since our inception and as a clinical stage company we have not generated any meaningful revenue to date.

Current 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.

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 $152.2 million as of September 30, 2025.

Current 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.

Previous wording

Expected cash payments related to existing contractual obligations for the 12-months ending September 30, 2026 include approximately $0.8 million under all of our operating lease agreements.

Current 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

Previous wording

Based on our cash, cash equivalents and marketable debt security investments totaling $152.2 million as of September 30, 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 for the three months ended September 30, 2025.

Current 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.

Previous wording

In addition to the clinical and regulatory milestone payments discussed above, upon the future commercialization of ersodetug and RZ402 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 RZ402, 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 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.

Previous wording

Based on our current forecast, we expect that our existing capital resources will be sufficient to fund 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 for the three months ended September 30, 2025. However, we will need to obtain additional equity or debt financing in order to fund all of our long-term liquidity requirements.

Current wording

Based on our current forecast, we expect that our existing capital resources will be sufficient to fund our short-term liquidity requirements. However, we will need to obtain additional equity or debt financing in order to fund all of our long-term liquidity requirements.

Previous wording

Presented below is an additional 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 September 30, 2025.

Current 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 December 31, 2025.

Previous wording

Upon the achievement of certain clinical and regulatory events, we will be required to make up to $37.0 million in aggregate milestone payments to XOMA. To date the Company has 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 the Company’s Phase 3 Clinical Trial for ersodetug and was paid in June 2025. We record a liability for milestone payments in our financial statements on the date that we achieve the milestone event. The next milestone payment of $25.0 million will be due upon the first regulatory approval of ersodetug by any regulatory authority. 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 September 30, 2025, no events have occurred that would result in the requirement to make additional milestone payments and no royalties have been incurred.

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 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.

Previous wording

various milestone payments ranging from $1.0 million to $10.0 million when milestone events occur, up to an aggregate of $46.5 million of aggregate milestone payments. To date the company has paid a total of $4.0 million in milestone payments consisting of (i) $1.0 million in December 2020 for clearance of an initial drug application (“IND”) filed with the FDA, and (ii) $3.0 million in February 2023 after dosing of the first patient in a Phase 2 clinical trial for RZ402. 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 sales of products that use the PKI Program. Through September 30, 2025, no events have occurred that would result in the requirement to make additional milestone payments and no royalties have been incurred.

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 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 of 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 sales of products that use the PKI Program. 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.

Previous wording

Presented below is a summary of our operating, investing, and financing cash flows for the three months ended September 30, 2025 and 2024 (in thousands):

Current wording

Presented below is a summary of our operating, investing, and financing cash flows for the six months ended December 31, 2025 and 2024 (in thousands):

Previous wording

For the three months ended September 30, 2025 and 2024, cash used in operating activities amounted to $17.4 million and $16.0 million, respectively. The key components in the calculation of our cash used in operating activities are as follows (in thousands):

Current wording

For the six months ended December 31, 2025 and 2024, cash used in operating activities amounted to $37.8 million and $29.7 million, respectively. The key components in the calculation of our cash used in operating activities are as follows (in thousands):

Previous wording

For the three months ended September 30, 2025, our net loss was $18.2 million compared to $15.4 million for the three months ended September 30, 2024. For further discussion about changes in our operating results for the three months ended September 30, 2025 and 2024, please refer toResults of Operations above.

Current wording

For the six months ended December 31, 2025, our net loss was $40.9 million compared to $31.1 million for the six months ended December 31, 2024. For further discussion about changes in our operating results for the six months ended December 31, 2025 and 2024, please refer toResults of Operations above.

Previous wording

For the three months ended September 30, 2025 and 2024, our non-cash expenses of $2.7 million and $1.6 million, respectively, were primarily attributable to share-based compensation expense and non-cash lease expense. For the three months ended September 30, 2025 and 2024, accretion of discounts and amortization of premiums on marketable debt securities amounted to $0.8 million. For the three months ended September 30, 2025, net changes in operating assets and liabilities decreased operating cash flow by $1.2 million, primarily driven by cash outflows resulting in a net decrease in accounts payable and other accrued liabilities of $1.8 million. This amount was partially offset by a net decrease of $0.7 million in prepaid expenses and other assets. For the three months ended September 30, 2024, net changes in operating assets and liabilities decreased operating cash flow by $1.4 million, primarily driven by a net decrease of $1.3 million in accounts payable and other accrued liabilities, and an increase in prepaid expenses and other assets of $0.1 million.

Current wording

For the six months ended December 31, 2025 and 2024, our non-cash expenses of $6.3 million and $3.1 million, respectively, were primarily attributable to share-based compensation expense and non-cash lease expense. For the six months ended December 31, 2025 and 2024, the net impact of accretion of discounts and amortization of premiums on marketable debt securities reduced operating cash flows by $1.5 million and $1.6 million, respectively. For the six months ended December 31, 2025, net changes in operating assets and liabilities decreased operating cash flow by $1.6 million, primarily driven by cash outflows that resulted in a net decrease in accounts payable and other accrued liabilities of $2.7 million. This amount was partially offset by a net decrease of $1.1 million in prepaid expenses and other assets. For the six months ended December 31, 2024, net changes in operating assets and liabilities decreased operating cash flow by $0.1 million, primarily driven by cash outflows that resulted in a net increase in prepaid expense and other assets of $1.4 million. This amount was partially offset by a net increase of $1.3 million in accounts payable and other accrued liabilities.

Previous wording

For the three months ended September 30, 2025, our net cash used in investing activities amounted to $68.5 million. For the three months ended September 30, 2025, we received proceeds of $20.4 million upon the maturity of certain marketable debt securities. These cash proceeds from maturities, along with certain proceeds from the 2025 Underwritten Offering in April 2025 and the 2025 Private Placement in June 2025, were used to purchase a total of $88.9 million of marketable debt securities.

Current wording

For the six months ended December 31, 2025, our net cash used in investing activities amounted to $45.7 million. For the six months ended December 31, 2025, we received proceeds of $70.1 million upon the maturity of certain marketable debt securities. These cash proceeds from maturities, along with certain proceeds from the 2025 Underwritten Offering in April 2025 and the 2025 Private Placement in June 2025, were used to purchase a total of $115.7 million of marketable debt securities.

Previous wording

For the three months ended September 30, 2024, our net cash used in investing activities amounted to $49.4 million. For the three months ended September 30, 2024, we received proceeds of $23.8 million upon the maturity of certain marketable debt securities. These cash proceeds from maturities, along with certain proceeds from the 2024 Public Underwritten Offering in June 2024 and 2024 Private Placement in July 2024, were used to purchase a total of $73.2 million of marketable debt securities.

Current wording

For the six months ended December 31, 2024, our net cash used in investing activities amounted to $37.9 million. For the six months ended December 31, 2024, we received proceeds of $60.7 million upon the maturity of certain marketable debt securities. These cash proceeds from maturities, along with certain proceeds from the 2024 Underwritten Offering in June 2024 and 2024 Private Placement in July 2024, were used to purchase a total of $98.7 million of marketable debt securities.

Previous wording

For the three months ended September 30, 2025, our net cash provided by financing activities was $0.9 million. Cash inflows amounted to $0.9 million from the exercise of stock options.

Current wording

For the six months ended December 31, 2025, our net cash provided by financing activities of $1.3 million was attributable to cash receipts from the exercise of stock options.

Previous wording

For the three months ended September 30, 2024, our net cash provided by financing activities was $5.5 million. Cash inflows amounted to $6.1 million, consisting of $6.0 million of proceeds from the 2024 Private Placement and $0.1 million of proceeds from the exercise of employee stock options. These amounts were partially offset by cash outflows related to the payments of offering costs of $0.6 million incurred in connection with the 2024 Public Underwritten Offering.

Current wording

For the six months ended December 31, 2024, our net cash provided by financing activities was $6.2 million. Cash inflows amounted to $6.8 million, consisting of proceeds of $6.0 million from the 2024 Private Placement and $0.8 million from the exercise of employee stock options. These amounts were partially offset by cash outflows related to the payment of offering costs of $0.6 million incurred in connection with the 2024 Underwritten Offering.