Rezolute Reports $18.9 Million Net Loss and Increased R&D Expenses for Fiscal Quarter Ending March 31, 2025

Rezolute, Inc. reported its financial results for the fiscal quarter ending March 31, 2025, revealing a net loss of $18.9 million, or $0.27 per share, compared to a net loss of $17.1 million, or $0.34 per share, for the same period in the previous year. The company's total operating expenses increased to $20.0 million from $16.2 million year-over-year, driven primarily by a rise in research and development (R&D) costs, which reached $15.3 million, up from $12.4 million. The increase in R&D expenses was attributed to higher costs associated with the development of its lead product candidate, ersodetug, as well as an increase in headcount.

In terms of liquidity, Rezolute's cash and cash equivalents decreased significantly to $14.6 million as of March 31, 2025, down from $70.4 million at the end of the previous fiscal year. The company also reported short-term investments in marketable debt securities of $72.3 million, reflecting a strategic focus on maintaining liquidity amid ongoing clinical trials. The total liabilities stood at $12.2 million, with current liabilities amounting to $10.5 million. The company has incurred cumulative net losses of $379.5 million since its inception and has not yet generated any revenue.

Strategically, Rezolute is advancing its clinical programs, particularly the Phase 3 trials for ersodetug, which has received Breakthrough Therapy Designation from the FDA. The company is actively enrolling patients in the sunRIZE study, aimed at treating congenital hyperinsulinism, with topline data expected in December 2025. Additionally, Rezolute is preparing to initiate a registrational study for tumor hyperinsulinism, with patient enrollment anticipated to begin in mid-2025. The company has also engaged in recent financing activities, including a $6.0 million private placement in July 2024 and a $96.9 million underwritten offering completed in April 2025.

Operationally, Rezolute's workforce has expanded, with an increase in R&D personnel from 39 to 48 employees year-over-year, contributing to the rise in operational costs. The company is also focused on enhancing its market presence, with ongoing discussions for potential partnerships to further develop its product pipeline. Despite the challenges of being a clinical-stage company, Rezolute's management believes that its existing cash, cash equivalents, and investments will be sufficient to meet its contractual obligations and support ongoing clinical trials through at least May 2026.