Clinical-stage biopharmaceutical company (pre-revenue) focused on R&D and incurring operating losses, financed primarily through marketable securities and equity financings.

# Company

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Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing therapies for hypoglycemia caused by hyperinsulinism.

# Company Overview: Rezolute, Inc.

**Business Focus:**
Rezolute, Inc. is a late-stage biopharmaceutical company dedicated to improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). The Company is actively developing innovative therapies for two primary forms of hypoglycemia: congenital HI and tumor HI.

## Clinical Assets

### 1. Ersodetug (formerly RZ358)
- **Description:** A human monoclonal antibody administered intravenously; it binds to a unique site on the insulin receptor, reducing insulin's action and counteracting elevated insulin effects, thus normalizing blood glucose levels.
- **Indications:**
  - **Congenital HI:** The most common cause of persistent hypoglycemia in children. There are no FDA-approved therapies for congenital HI in the U.S., with an estimated 1,500 individuals impacted.
    - **Phase 3 Trial (sunRIZE study):** Currently enrolling participants aged 3 months and older, evaluating safety and efficacy. Topline results are expected in the second half of calendar 2025.
  - **Tumor HI:** Arising from neuroendocrine or non-islet cell tumors, impacting approximately 1,500 patients in the U.S. (500 with insulinomas and 1,000 with NICTs).
    - **Upcoming Phase 3 Registrational Study:** Initiating in 2025, focusing on patients with uncontrolled hypoglycemia due to tumor HI.

### 2. RZ402
- **Description:** An orally administered plasma kallikrein inhibitor aimed at the chronic treatment of diabetic macular edema (DME), a major cause of blindness linked to diabetes.
- **Recent Study:** Completed a Phase 2 trial with 94 participants, showing positive results, including a significant reduction in central subfield thickness and good safety/tolerability. The program is open for partnering.

## Financials
- **Employee Count:** 59 full-time employees as of June 30, 2024. 
  - **R&D Staff:** 42 employees focused on research, development, manufacturing, and regulatory affairs.
  - **Administrative Staff:** 17 employees in administrative roles.
- **Research and Development Expenses:**
  - **FY 2024:** $55.7 million
  - **FY 2023:** $43.8 million
- **Net Loss:**
  - **FY 2024:** $68.5 million
  - **FY 2023:** $51.8 million
- **Cash and Investments:** As of June 30, 2024:
  - **Cash and Cash Equivalents:** $70.4 million
  - **Marketable Debt Securities:** $56.7 million
- **Accumulate Deficit:** $329.4 million

## Market and Competition
- **Congenital HI:** No U.S. FDA-approved therapies; the current market is addressed with suboptimal treatments, indicating a significant opportunity for ersodetug.
- **Tumor HI:** The Company is entering a market with notable unmet needs, with current therapies not sufficiently addressing hypoglycemia caused by tumors.
- **Competitors for HI Therapy:** Amylyx Pharmaceuticals, Hanmi Pharmaceuticals, Zealand Pharma.
- **Competitors for DME Therapy:** Curacle, KalVista, Ocuphire Pharma, Oxurion, Verseon.

## Conclusion
Rezolute, Inc. is strategically positioned in the biopharmaceutical space with a focus on treating rare diseases associated with hypoglycemia. With a solid pipeline of clinical candidates and a commitment to innovative treatment solutions, the Company is poised to address significant unmet medical needs while navigating challenges in product development and financial stability.

Rezolute, Inc.

10-K / September 24, 2026

10-K / September 19, 2024

10-K / September 24, 2026

Company