Rezolute Inc

Previous wording

Our priority in the first half of 2025 is to execute across our two Phase 3 clinical trials. Our goals include (i) complete enrollment of ex-U.S. participants in the sunRIZE study (as defined below), (ii) progress study start-up activities in the U.S. to enable U.S. participant enrollment in the sunRIZE study, and (iii) advance study start-up activities and begin enrollment for the Phase 3 registrational tumor HI study.

Current wording

Our priority in the first half of 2025 is to execute across our two Phase 3 clinical trials. Our goals include (i) complete enrollment of the sunRIZE study (as defined below) to enable topline data in December 2025, and (ii) advance study start-up activities and begin enrollment for the registrational tumor HI study in mid-2025.

Previous wording

We are currently conducting study start-up activities at sites in the U.S. Topline results from the study are anticipated to be available in Q4 of calendar 2025, but the specific date of the availability of such results may vary.

Current wording

We are currently enrolling at all sites globally, including the U.S. Topline results from the study are anticipated to be available in December of calendar 2025, but the specific date of the availability of such results may vary.

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

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

Previous wording

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 that are unresponsive to medical management, surgical removal of the pancreas may be required. In those with diffuse disease where the whole pancreas is affected, a near-total pancreatectomy can 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 U.S. FDA approved therapies for all forms of congenital HI and the current standard of care treatments are suboptimal. The current treatments used by physicians include glucagon, diazoxide, somatostatin analogues and pancreatectomy. We estimate that in the U.S. alone the immediately addressable market for congenital HI is more than 1,500 individuals.

Current wording

significant impact on patient and family quality of life. In cases that are unresponsive to medical management, surgical removal of the pancreas may be required. In those with diffuse disease where the whole pancreas is affected, a near-total pancreatectomy can 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 current treatments used by physicians 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.

Previous wording

Additionally, ersodetug has received PRIME and Innovation Passport (ILAP) designations in the European Union and U.K., respectively. Ersodetug also has Orphan Drug Designation in both regions, for the treatment of hypoglycemia due to 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.

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 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 the Breakthrough Therapy Designation by the FDA in the United States. Additionally, ersodetug has received PRIME and ILAP designations in the European Union and United Kingdom, respectively.

Previous wording

We are initiating start-up activities for a Phase 3 registrational study of ersodetug for the treatment of hypoglycemia due to tumor HI, and patient enrollment is planned to commence in Q2 of calendar 2025. Topline results from the study are anticipated to be available in the second half of calendar 2026, but the specific date of the availability of such results may vary.

Current wording

We are initiating start-up activities for a registrational study of ersodetug for the treatment of hypoglycemia due to tumor HI, and patient enrollment is planned to commence in the middle of calendar 2025. Topline results from the study are anticipated to be available in the second half of calendar 2026, but the specific date of the availability of such results may vary.

Previous wording

The Phase 3 registrational study is a double-blind, randomized, placebo-controlled trial of 24 participants who have inadequately controlled hypoglycemia because of tumor HI. Eligible participants will be randomized in 1:1 fashion (12 per treatment arm) to receive ersodetug 9 mg/kg per week or matched placebo, as an add-on to standard of care. Up to 24 additional participants may be enrolled into an open-label arm, in participants whose hypoglycemia is being managed by IV glucose in a hospital setting. Following an 8-week pivotal treatment period, all participants may receive ersodetug in open-label extension. The primary endpoint is the change in Level 2 (moderate) and Level 3 (severe) hypoglycemia events by self-monitored blood glucose. Additional endpoints include overall hypoglycemia events, time in hypoglycemia by continuous glucose monitor, patient reported quality of life, hospitalizations, and change in glucose requirements (for open-label hospitalized participants.

Current wording

The registrational study is a double-blind, randomized, placebo-controlled trial of 24 participants who have inadequately controlled hypoglycemia because of tumor HI. Eligible participants will be randomized in 1:1 fashion (12 per treatment arm) to receive ersodetug 9 mg/kg per week or matched placebo, as an add-on to standard of care. Up to 24 additional participants may be enrolled into an open-label arm, in participants whose hypoglycemia is being managed by IV glucose in a hospital setting. Following an 8-week pivotal treatment period, all participants may receive ersodetug in open-label extension. The primary endpoint is the change in Level 2 (moderate) and Level 3 (severe) hypoglycemia events by self-monitored blood glucose. Additional endpoints include overall hypoglycemia events, time in hypoglycemia by continuous glucose monitor, patient reported quality of life, hospitalizations, and change in glucose requirements for open-label hospitalized participants.

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

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

A significant unmet need exists for treatment options with improved efficacy and tolerability as normalization of glucose levels is crucial to prevent serious signs and symptoms of hypoglycemia, improve patient quality of life and overall function, and even to ensure patients are fit to receive cancer treatment and to reduce mortality. Unfortunately, some patients are unresponsive to the current standard of care medical therapies for tumor HI and experience debilitating hypoglycemia that is otherwise untreatable. Currently available medical therapies are directed at reducing or eliminating insulin production and/or secretion from tumors, which may be challenging when the tumor is differentiated or dysregulated, and therefore not responding to usual control mechanisms for suppressing insulin production. In

Current wording

A significant unmet need exists for treatment options with improved efficacy and tolerability as normalization of glucose levels is crucial to prevent serious signs and symptoms of hypoglycemia, improve patient quality of life and overall function, and even to ensure patients are fit to receive cancer treatment and to reduce mortality. Unfortunately, some patients are unresponsive to the current standard of care medical therapies for tumor HI and experience debilitating hypoglycemia that is otherwise untreatable. Currently available medical therapies are directed at reducing or eliminating insulin production and/or secretion from tumors, which may be challenging when the tumor is differentiated or dysregulated, and therefore not responding to usual control mechanisms for suppressing insulin production. In some cases, commonly utilized somatostatin analog therapies may even worsen hypoglycemia due to suppression of glucagon. Therefore, currently available medical therapies directed at suppressing insulin production may have limited effectiveness in tumor HI.

Previous wording

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 nine patients with tumor HI. In the U.S., these requests have all been indvidually approved by the Division. The tumor HI patients dosed have been refractory to the standard of care therapies for chronic management of hypoglycemia. They were generally requiring 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 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 nine patients with tumor HI. In the U.S., these requests have all been individually approved by the Division. The tumor HI patients dosed have been refractory to the standard of care therapies for chronic management of hypoglycemia. They 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.

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 1 year in several instances, in this subset of tumor HI patients with significantly advanced and metastatic tumor burden. Presently, 5 patients are receiving ersodetug in an ongoing fashion, including one patient who has been successfully treated for 15 months, and several other patients have recently been brought to our attention and are currently under consideration for possible treatment.

Current 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 1 year in several instances, in this subset of tumor HI patients with significantly advanced and metastatic tumor burden. Presently, 3 patients are receiving ersodetug in an ongoing fashion, including one patient who has been successfully treated for more than one year, and several other patients have recently been brought to our attention and are currently under consideration for possible treatment.

Previous wording

Four patients with cHI 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 patient where off-label or surgical (pancreatectomy) therapies were being considered. The duration of treatment in these participants ranges from 6 months to more than 2 years, with ongoing benefit.

Current wording

Four patients with cHI 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 patient where off-label or surgical (pancreatectomy) therapies were being considered. The duration of treatment in these participants ranges from 1 year to approximately 3 years, with ongoing benefit.

Previous wording

On June 13, 2024, we entered into an underwriting agreement for the planned issuance and sale of equity securities in an underwritten public offering (the “2024 Underwritten Offering”). The 2024 Underwritten Offering provided for the issuance of (i) 11,250,000 shares of common stock at a price of $4.00 per share for gross proceeds of $45.0 million, and (ii) pre-funded warrants to purchase 3,750,000 shares of common stock at a public offering price of $3.999 per pre-funded warrant (the “2024 PFWs”) for gross proceeds of $15.0 million. The Company granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of its common stock at a public offering price of $4.00 per share, less underwriting discounts of 6.0% of the gross proceeds. The underwriters’ option was partially exercised for 1,786,589 shares of common stock for gross proceeds of $7.1 million. Closing occurred on June 24, 2024, whereby the aggregate gross proceeds amounted to $67.1 million. The net proceeds of the 2024 Underwritten Offering amounted to approximately $62.6 million. In July 2024, we utilized approximately $59.7 million of the net proceeds from the 2024 Underwritten Offering to purchase investments in marketable debt securities with maturities that range from October 2024 through December 2025.

Current wording

On June 13, 2024, we entered into an underwriting agreement for the planned issuance and sale of equity securities in an underwritten public offering (the “2024 Underwritten Offering”). The 2024 Underwritten Offering provided for the issuance of (i) 11,250,000 shares of common stock at a price of $4.00 per share for gross proceeds of $45.0 million, and (ii) pre-funded warrants to purchase 3,750,000 shares of common stock at a public offering price of $3.999 per pre-funded warrant (the “2024 PFWs”) for gross proceeds of $15.0 million. The Company granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of its common stock at a public offering price of $4.00 per share. The underwriters’ option was partially exercised for 1,786,589 shares of common stock for gross proceeds of $7.1 million. Closing occurred on June 24, 2024, whereby the aggregate gross proceeds amounted to $67.1 million. The net proceeds of the 2024 Underwritten Offering amounted to approximately $62.6 million, after deducting underwriting commissions and other offering costs. In July 2024, we utilized approximately $59.7 million of net proceeds from the 2024 Underwritten Offering to purchase investments in marketable debt securities with maturities that range from October 2024 through December 2025.

Previous wording

Loss from change in fair value of derivative liability. 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 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.

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 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.

Current wording

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

cost of the equity awards over the period that services are provided to earn the award. For 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 by employees, all unrecognized compensation is immediately recognized in the period the options are cancelled.

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 the equity awards with time-based vesting using the BSM option-pricing model and recognize the cost of the equity awards over the period that services are provided to earn the award. For 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.

Previous wording

Revenue. As a late-stage rare disease company, we did not generate any revenue for the three and six months ended December 31, 2024 and 2023. 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 for several years.

Current wording

Revenue. As a late-stage rare disease company, we did not generate any revenue for the three and nine months ended March 31, 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 for several years.

Previous wording

The increase in R&D expenses of $0.6 million for the three months ended December 31, 2024 was primarily attributable to $2.8 million net increase in ersodetug R&D costs, partially offset by a decrease of $2.2 million in RZ402 and other R&D related costs.

Current wording

The increase in R&D expenses of $2.9 million for the three months ended March 31, 2025 was primarily attributable to (i) a $3.5 million increase in ersodetug R&D costs, and (ii) a $1.0 million increase in R&D headcount costs, partially offset by a decrease of $1.7 million in RZ402 and other R&D related costs.

Previous wording

The increase in ersodetug R&D costs was driven by (i) $2.8 million of manufacturing related costs for pre-commercial batch production of drug product and (ii) $0.6 million in clinical costs due to startup activities in 2024 for the tHI phase 3 study expected to be initiated in the Q2 of calendar 2025. For the three months ended December 31, 2023, there were no clinical costs incurred for tHI related program spend. These increased were offset by decreases of $0.6 million in preclinical and toxicology related ersodetug costs. This decrease was due to increased costs related to toxicology studies pursued to release the partial clinical hold on the sunRIZE study.

Current wording

The increase in ersodetug R&D costs was driven by (i) $1.9 million of manufacturing related costs for process performance qualification batch production of drug product, (ii) $1.0 million in clinical costs due to startup activities in 2024 for the tumor HI phase 3 study which we are in preparation for first patient enrollment anticipated in the second quarter of calendar 2025, and (iii) a $0.9 million increase in clinical trial costs due to the ongoing enrollment of patients in the cHI phase 3 clinical study. These increases amount to $3.8 million and were partially offset by a $0.3 million decrease in preclinical, toxicology and other ersodetug costs after the partial clinical hold on the sunRIZE study was lifted by the FDA in September 2024, requiring no further toxicology studies for that specific purpose. For the three months ended March 31, 2024, there were no clinical costs incurred for tumor HI related program spend as this study had yet to be initiated and there were fewer clinical costs for cHI as we had not enrolled any patients in the sunRIZE study as of March 31, 2024.

Previous wording

The increase in G&A expenses of $1.3 million for the three months ended December 31, 2024, was primarily attributable to an increase in consulting expenses of $0.8 million related to business development and market planning activities in preparation for future commercial activities, such as market research, and an increase of $0.5 million in compensation and benefits for our G&A workforce.

Current wording

The increase in G&A expenses of $0.9 million for the three months ended March 31, 2025, was primarily attributable to an increase of $0.5 million in compensation and benefits for our G&A workforce, and an increase in consulting expenses of $0.4 million related to business development and market planning activities in preparation for future ersodetug commercial activities, such as market research.

Previous wording

Cash-based compensation and benefits for our G&A workforce increased by approximately $0.8 million and was partially offset by a reduction of share-based compensation of $0.3 million. This $0.8 million increase in cash-based compensation was attributable to an increase in the average number of G&A employees from 13 for the three months ended December 31, 2023, to 18 employees for the

Current wording

The $0.5 million increase in G&A cash compensation was primarily attributable to an increase in the average number of G&A employees from 16 for the three months ended March 31, 2024, to 20 employees for the three months ended March 31, 2025.

Previous wording

Interest and other income. Interest and other income amounted to $1.3 million for the three months ended December 31, 2024 and 2023. Interest and other income received is from our investments in marketable debt securities.

Current wording

Interest and other income. Interest and other income amounted to $1.1 million for the three months ended March 31, 2025 and 2024. Interest and other income received is primarily from our investments in marketable debt securities.

Previous wording

Research and development expenses. R&D expenses for the six months ended December 31, 2024 and 2023 were as follows (in thousands, except percentages):

Current wording

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

Previous wording

The increase in R&D expenses of $1.1 million for the six months ended December 31, 2024 was primarily attributable to (i) an increase of $4.1 million related to ersodetug R&D costs, (ii) an increase of $0.9 million in other preclinical, toxicology and facility related costs, and (iii) an increase of $0.2 million in R&D compensation and benefits costs. These increases amount to $5.4 million and were partially offset by a $4.1 million decrease in costs related to RZ402 program spend as there is no active RZ402 study in the current period.

Current wording

The increase in R&D expenses of $4.0 million for the nine months ended March 31, 2025 was primarily attributable to (i) an increase of $8.2 million related to ersodetug R&D costs and (ii) an increase of $1.5 million in other R&D costs. These increases amount to $9.7 million and were partially offset by a $5.7 million decrease in costs related to RZ402 program spend as there are no active RZ402 studies in the current period while we are actively seeking a partner to continue development of this program.

Previous wording

The net increase in ersodetug costs of $4.1 million was attributable to (i) $4.5 million of manufacturing related costs for pre-commercial and phase 3 clinical drug supply, (ii) $0.7 million of clinical related costs incurred for the tHI phase 3 study and (iii) $0.3 million of sunRIZE related clinical trial costs due to increased enrollment. These increases amount to $5.5 million and were partially offset by a $1.4 million decrease in preclinical, toxicology and other ersodetug costs that were eliminated after the partial clinical hold on the sunRIZE study was lifted by the FDA in September 2024.

Current wording

The net increase in ersodetug costs of $8.2 million was attributable to (i) $6.3 million of manufacturing related costs for process performance qualification batch production of drug product, which will also continue support both phase 3 studies and EAPs, (ii) $1.8 million of clinical related costs incurred for the tumor HI phase 3 study for which startup activities were initiated in August 2024 after clearance of our IND application and anticipating enrollment of the first patient in the study in the second quarter of calendar 2025 and (iii) $0.9 million of costs for the sunRIZE clinical trial which did not enroll its first patient until April 2024, and we are tracking to complete enrollment in the study in May 2025. These increases amount to $9.0 million and were partially offset by a $0.8 million decrease in preclinical, toxicology and other ersodetug costs that were no longer required to support our efforts to remove the partial clinical hold on the sunRIZE study, which was lifted by the FDA in September 2024.

Previous wording

General and administrative expenses. G&A expenses for the six months ended December 31, 2024 and 2023 were as follows (in thousands, except percentages):

Current wording

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

Previous wording

The increase in G&A expenses of $1.8 million for the six months ended December 31, 2024, was primarily attributable to an increase in consulting expenses of $1.1 million related to business development and market planning activities and an increase of $0.8 million in compensation and benefits for our G&A workforce. These increases amount to $2.0 million and were partially offset by a $0.1 million decrease in information technology costs.

Current wording

The increase in G&A expenses of $2.7 million for the nine months ended March 31, 2025, was primarily attributable to (i) an increase in consulting expenses of $1.5 million related to business development, market planning activities for ersodetug and other professional service fees, and (ii) an increase of $1.2 million in compensation and benefits for our G&A workforce.

Previous wording

Cash-based compensationand benefits for our G&A workforce increased by approximately $1.4 million and was partially offset by a reduction of share-based compensation of $0.6 million. This $1.4 million increase in cash-based compensation was primarily attributable to an increase in the average number of G&A employees from 14 for the six months ended December 31, 2023, to 18 employees for the six months ended December 31, 2024. Share-based compensation for our G&A workforce decreased by $0.6 million from $2.0 million

Current wording

Cash-based compensationand benefits for our G&A workforce increased by approximately $1.9 million and was partially offset by a reduction of share-based compensation of $0.7 million. This $1.9 million increase in cash-based compensation was primarily attributable to an increase in the average number of G&A employees from 14 for the nine months ended March 31, 2024, to 18 employees for the nine months ended March 31, 2025. Share-based compensation for our G&A workforce decreased by $0.7 million from $3.1 million for the nine months ended March 31, 2024 to $2.4 million for the nine months ended March 31, 2025. This decrease in share-based compensation expense was primarily attributable to stock options that became fully vested during the fiscal year ended June 30, 2024.

Previous wording

Interest and Other Income. Interest and other income amounted to $2.9 million for the six months ended December 31, 2024, compared to $2.7 million for the six months ended December 31, 2023. This increase of $0.2 million was primarily due to an increase in the average value of money market funds and investments in marketable debt securities from $94.2 million at December 31, 2023 to $101.2 million as of December 31, 2024. Investment balances were higher due to proceeds from the 2024 Underwritten Offering and 2024 Private Placement, offset by investment maturities that were utilized to fund operating activities. Investments in marketable debt securities are our primary source of liquidity to fund clinical expenditures and other operating expenses.

Current wording

value of money market funds and investments in marketable debt securities from $79.1 million at March 31, 2024 to $85.0 million as of March 31, 2025. Investment balances were higher due to proceeds from the 2024 Underwritten Offering and 2024 Private Placement, offset by investment maturities that were utilized to fund operating activities. Investments in marketable debt securities are our primary source of liquidity to fund clinical expenditures and other operating expenses.

Previous wording

Income Taxes. For the six months ended December 31, 2024 and 2023, we did not recognize any income tax benefit due to our net losses, and our determination that a valuation allowance was required for all of our deferred tax assets.

Current wording

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

Previous wording

As of December 31, 2024, we had cash and cash equivalents of $8.9 million, short-term marketable debt securities of $87.6 million and working capital was approximately $88.1 million. We have incurred cumulative net losses of $360.6 million since our inception and as a clinical stage company we have not generated any meaningful revenue to date. Our most significant contractual obligations consist of milestone payments pursuant to licensing agreements with XOMA Corporation (“XOMA”) and ActiveSite Pharmaceuticals, Inc. (“ActiveSite”) discussed below.

Current wording

As of March 31, 2025, we had cash and cash equivalents of $14.6 million, short-term marketable debt securities of $72.3 million and working capital was approximately $78.2 million. We have incurred cumulative net losses of $379.5 million since our inception and as a clinical stage company we have not generated any meaningful revenue to date. Our most significant contractual obligations consist of milestone payments pursuant to licensing agreements with XOMA Corporation (“XOMA”) and ActiveSite Pharmaceuticals, Inc. (“ActiveSite”) discussed below.

Previous wording

Our primary source of liquidity has historically been from the completion of private placements and public offerings of our equity securities, as well as proceeds from the issuance of debt securities. For the six months ended December 31, 2024, we received proceeds of $6.0 million related to a private placement of 1.5 million shares of common stock. For further information about the key terms and results of our equity financing activities completed in June 2024 for net proceeds of $62.6 million and July 2024 for net proceeds of $6.0 million, please refer to the discussion above under the caption Recent Developments. The completion of equity financings between May 2022 and July 2024 is the primary source of our total cash, cash equivalents and short-term investments in marketable debt securities of $96.5 million as of December 31, 2024.

Current wording

Our primary source of liquidity has historically been from the completion of private placements and public offerings of our equity securities, as well as proceeds from the issuance of debt securities. For the nine months ended March 31, 2025, we received proceeds of $6.0 million related to a private placement of 1.5 million shares of common stock. Additionally, in April 2025 we completed the 2025 Underwritten Offering that resulted in net proceeds of $96.9 million from the issuance of 24.9 million shares of common stock and pre-funded warrants to purchase 6.9 million shares of common stock. For further information about the key terms and results of our recent equity financing activities please refer to the discussion above under the caption Recent Developments. The completion of equity financings between May 2022 and July 2024 is the primary source of our total cash, cash equivalents and short-term investments in marketable debt securities of $86.9 million as of March 31, 2025.

Previous wording

Based on our cash and cash equivalents balance of $8.9 million and investments in short-term marketable debt securities balance of $87.6 million as of December 31, 2024, we believe we have adequate capital resources to meet all of our contractual obligations and conduct all planned activities to advance our clinical trials at least through the next 12 months.

Current wording

Based on our cash and cash equivalents balance of $14.6 million and investments in short-term marketable debt securities balance of $72.3 million as of March 31, 2025, combined with the net proceeds of $96.9 million received in the 2025 Underwritten Offering, we believe we have adequate capital resources to meet all of our contractual obligations and conduct all planned activities to advance our clinical trials at least through the next 12 months.

Previous wording

Our most significant long-term contractual obligations consist of additional clinical and regulatory milestone payments up to $30.0 million payable to XOMA and additional milestone payments up to $25.0 million payable to ActiveSite. Of these amounts, we expect that $5.0 million will be payable to XOMA during the 12-month period ending December 31, 2025 as discussed above under the caption Short-term Liquidity Requirements. Up to $50.0 million of the remaining milestone payments that may become payable are considered a long-term liquidity requirement. Due to uncertainties in the timing associated with clinical trial activities and regulatory approvals,

Current wording

Our most significant long-term contractual obligations consist of additional clinical and regulatory milestone payments up to $30.0 million payable to XOMA and additional milestone payments up to $25.0 million payable to ActiveSite. Of these amounts, we expect that $5.0 million will be payable to XOMA during the 12-month period ending March 31, 2026 as discussed above under the caption Short-term Liquidity Requirements. Up to $50.0 million of the remaining milestone payments that may become payable are considered

Previous wording

there is even greater uncertainty in forecasting the timing of future clinical and regulatory milestone payments to XOMA and ActiveSite that may extend beyond the next 12 months.

Current wording

a long-term liquidity requirement. Due to uncertainties in the timing associated with clinical trial activities and regulatory approvals, there is even greater uncertainty in forecasting the timing of future clinical and regulatory milestone payments to XOMA and ActiveSite that may extend beyond the next 12 months.

Previous wording

In August 2017, we entered into a Development and License Agreement with ActiveSite (“ActiveSite License Agreement”) pursuant to which we acquired the rights to ActiveSite’s PKI portfolio. We are planning to use the PKI Program to develop, file, manufacture, market and sell products for diabetic macular edema and other therapeutic indications. The ActiveSite License Agreement requires 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. The first milestone payment for $1.0 million was paid in December 2020 after completion of preclinical work and submission of an IND to the FDA for RZ402. The second milestone payment for $3.0 million became due upon dosing of the first patient in a Phase 2 study in February 2023. Remaining milestone payments under the ActiveSite License Agreement

Current wording

In August 2017, we entered into a Development and License Agreement with ActiveSite (“ActiveSite License Agreement”) pursuant to which we acquired the rights to ActiveSite’s PKI portfolio. We are planning to use the PKI Program to develop, file, manufacture, market and sell products for diabetic macular edema and other therapeutic indications. The ActiveSite License Agreement requires 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. The first milestone payment for $1.0 million was paid in December 2020 after completion of preclinical work and submission of an IND to the FDA for RZ402. The second milestone payment for $3.0 million became due upon

Previous wording

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, 2024, no events have occurred that would result in the requirement to make additional milestone payments and no royalties have been incurred.

Current wording

dosing of the first patient in a Phase 2 study in February 2023. 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 March 31, 2025, no events have occurred that would result in the requirement to make additional milestone payments and no royalties have been incurred.

Previous wording

Presented below is a summary of our operating, investing, and financing cash flows for the six months ended December 31, 2024 and 2023 (in thousands):

Current wording

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

Previous wording

For the six months ended December 31, 2024 and 2023, cash used in operating activities amounted to $29.7 million and $23.6 million, respectively. The key components in the calculation of our cash used in operating activities are as follows (in thousands):

Current wording

For the nine months ended March 31, 2025 and 2024, cash used in operating activities amounted to $47.1 million and $38.8 million, respectively. The key components in the calculation of our cash used in operating activities are as follows (in thousands):

Previous wording

For the six months ended December 31, 2024, our net loss was $31.1 million compared to $28.4 million for the six months ended December 31, 2023. For further discussion about changes in our operating results for the six months ended December 31, 2024 and 2023, please refer toResults of Operations above.

Current wording

For the nine months ended March 31, 2025, our net loss was $50.0 million compared to $45.5 million for the nine months ended March 31, 2024. For further discussion about changes in our operating results for the nine months ended March 31, 2025 and 2024, please refer toResults of Operations above.