Rezolute Reports $15.7 Million Net Loss and Increased R&D Expenses for Fiscal Quarter Ending December 31, 2024

Rezolute, Inc. reported a net loss of $15.7 million for the fiscal quarter ending December 31, 2024, compared to a net loss of $13.9 million for the same period in the previous year. The company's total operating expenses increased to $17.1 million from $15.2 million year-over-year, driven primarily by a rise in research and development (R&D) costs associated with its lead product candidate, ersodetug. R&D expenses for the quarter were $12.6 million, reflecting a 5% increase from $12.0 million in the prior year, largely due to pre-commercial batch production and clinical trial activities. General and administrative expenses also rose significantly, increasing by 41% to $4.5 million, attributed to higher consulting and compensation costs.

In terms of financial position, Rezolute's total assets decreased to $112.0 million as of December 31, 2024, down from $132.7 million at the end of the previous fiscal year. The decline was primarily due to a reduction in cash and cash equivalents, which fell to $8.9 million from $70.4 million. The company’s accumulated deficit increased to $360.6 million, reflecting ongoing operational losses. Despite these challenges, Rezolute's investments in marketable debt securities rose significantly, totaling $96.4 million, indicating a strategic focus on maintaining liquidity through short-term investments.

Strategically, Rezolute is advancing its clinical trials for ersodetug, which has received Breakthrough Therapy Designation from the FDA for treating congenital hyperinsulinism. The company is currently enrolling participants in its pivotal Phase 3 sunRIZE study and plans to initiate a Phase 3 registrational study for tumor hyperinsulinism in the second quarter of 2025. The company has also expanded its workforce, increasing its R&D headcount from 43 to 46 employees, which is expected to support its clinical development efforts.

Operationally, Rezolute has not generated any revenue to date, as it remains focused on clinical development. The company’s cash flow from operating activities for the six months ended December 31, 2024, was a net outflow of $29.7 million, compared to $23.6 million for the same period in 2023. This increase in cash used reflects the company's ongoing investment in R&D and clinical trials. The company anticipates that its existing cash and marketable securities will be sufficient to fund its operations and contractual obligations through at least February 2026.

Looking ahead, Rezolute's management remains optimistic about the potential of its product candidates and plans to continue executing its clinical development strategy. The company is focused on completing enrollment in its ongoing studies and advancing its pipeline, while also exploring additional financing options to support its long-term growth objectives. However, the company acknowledges the inherent risks and uncertainties associated with clinical trials and regulatory approvals, which could impact its future financial performance.