Financial Performance - Cash, cash equivalents, and investments in marketable securities were 118.4 million as of June 30, 2023, representing a 6.1% increase[6] - Net loss for Q4 fiscal 2024 was 12.7 million for the same period last year, an increase of 81.1%; full year fiscal 2024 net loss was 51.8 million in fiscal year 2023, a 32.3% increase[7] - Total operating expenses for Q4 fiscal 2024 were 14.2 million for the same period last year, a 62.3% increase; full fiscal year 2024 total operating expenses were 56.0 million in fiscal year 2023, a 25.7% increase[12] Research and Development - Research and development (R&D) expenses for Q4 fiscal 2024 were 10.9 million in the same period last year, marking a 75.7% increase; full fiscal year 2024 R&D expenses totaled 43.8 million in fiscal year 2023, a 27.5% increase[6] - Positive topline results from the Phase 2 proof-of-concept study of RZ402 for diabetic macular edema (DME) were announced, showing significant reduction in central subfield thickness (CST) of up to approximately 50 microns compared to placebo[5] - The company has engaged in discussions with potential partners for further development of RZ402[5] Regulatory Updates - The FDA lifted partial clinical holds on ersodetug for congenital hyperinsulinism (HI), allowing U.S. participant enrollment in the Phase 3 sunRIZE study to begin in early 2025[2] - The FDA cleared the IND application for the Phase 3 study of ersodetug for tumor HI, with patient enrollment anticipated to begin in the first half of 2025 and topline results expected in mid-2026[4] - Topline results from the sunRIZE study are expected in the second half of 2025[3] Administrative Expenses - General and administrative (G&A) expenses for Q4 fiscal 2024 were 3.3 million for the same period a year ago, a 21.2% increase; full fiscal year 2024 G&A expenses were 12.2 million in fiscal year 2023, a 20.5% increase[7]
Rezolute(RZLT) - 2024 Q4 - Annual Results