Rezolute(US:RZLT)2026-02-12 21:36Financial Performance - The company reported a net loss of $40.924 million for the six months ended December 31, 2025, compared to a net loss of $31.108 million for the same period in 2024, indicating a 31% increase in losses year-over-year [14]. - The company reported a comprehensive loss of $40.870 million for the six months ended December 31, 2025, compared to a comprehensive loss of $30.965 million for the same period in 2024, reflecting a 32% increase [14]. - The Company incurred a net loss of $40.9 million and net cash used in operating activities amounted to $37.8 million for the six months ended December 31, 2025 [39]. - The Company reported a consolidated net loss of $22.77 million for the three months ended December 31, 2025, compared to a net loss of $15.73 million for the same period in 2024, representing a 44.5% increase in net loss year-over-year [130]. Assets and Liabilities - As of December 31, 2025, total assets decreased to $138.629 million from $175.490 million as of June 30, 2025, representing a decline of approximately 21% [12]. - The total liabilities decreased to $10.631 million as of December 31, 2025, from $13.363 million as of June 30, 2025, a reduction of approximately 20% [12]. - As of December 31, 2025, the Company had an accumulated deficit of $444.8 million, with cash and cash equivalents of $11.9 million and short-term investments in marketable debt securities of $121.0 million [39]. - The Company has total liabilities of $10.6 million, including current liabilities of $9.5 million, and is subject to a $25.0 million milestone payment upon regulatory approval of ersodetug [42]. Cash and Investments - Cash and cash equivalents at the end of the period were $11.944 million, down from $94.107 million at the beginning of the period, reflecting a decrease of approximately 87% [20]. - As of December 31, 2025, investments in marketable debt securities had an aggregate fair value of $121.0 million, scheduled to mature during the 12-month period ending December 31, 2026 [45]. - The Company did not recognize any allowance for credit losses or impairment related to investments in marketable debt securities for the six months ended December 31, 2025 [48]. - As of December 31, 2025, the total fair value of the Company's financial assets measured at fair value was $129.12 million, with $8.13 million classified as Level 1 and $120.99 million as Level 2 [117]. Research and Development - Research and development expenses increased to $27.497 million for the six months ended December 31, 2025, compared to $25.381 million in the same period of 2024, marking an 8% increase [14]. - Research and development expenses for the three months ended December 31, 2025, totaled $14.35 million, an increase from $12.63 million in the same period of 2024, reflecting a 13.6% year-over-year growth [130]. - The increase in R&D expenses was primarily due to a $1.6 million rise in R&D compensation and benefits, including $0.9 million in one-time severance benefits [175]. - R&D costs for ersodetug decreased by $3.2 million, primarily due to a $6.0 million reduction in drug substance and product manufacturing, partially offset by a $1.5 million increase in clinical trial costs for the congenital HI phase 3 study [184]. Workforce and Severance - The Company accrued approximately $1.5 million of one-time severance benefits due to a workforce reduction, which was paid in full in January 2026 [43]. - A reduction in workforce of 29 employees was announced on December 15, 2025, resulting in approximately $1.5 million of one-time severance expenses [132]. - The average number of R&D employees increased from 46 to 51 for the three months ended December 31, 2025, contributing to higher compensation costs [175]. Stock and Equity - The company issued 8,223,879 shares through cashless exercises of pre-funded warrants, contributing to an increase in common stock outstanding from 86,995,985 to 95,547,998 shares [17]. - The total shareholders' equity was $127.998 million, a decrease from $147.168 million as of September 30, 2025, reflecting a net loss of $22.774 million for the quarter [62]. - The Company granted stock options for 275,000 shares at an exercise price of $6.55 per share as inducement awards in August 2025, with a fair value of $1.3 million [77]. - The total share-based compensation expense for the six months ended December 31, 2025, was $5.942 million, compared to $2.845 million for the same period in 2024 [98]. Clinical Trials and Regulatory Matters - The company is currently enrolling in a Phase 3 clinical trial for a tumor HI indication ("upLIFT") and plans to meet with the FDA to discuss results from a previous Phase 3 trial that did not meet its endpoints [24]. - The sunRIZE Phase 3 clinical trial did not meet its primary or key secondary endpoints, with the study demonstrating reductions in hypoglycemia events but not statistically significant compared to the placebo group [136]. - The Company aims to achieve alignment with the FDA on the path forward in congenital hyperinsulinism and complete enrollment in the registrational tumor HI study in 2026 [135]. - The Phase 3 upLIFT study results are anticipated in the second half of 2026, following modifications agreed upon with the FDA [145]. Market and Product Development - The initial addressable pediatric market for congenital hyperinsulinism (HI) in the U.S. is estimated to be over 1,500 individuals, with potential growth as ersodetug is used in patients who are partially responsive to current treatments [143]. - The total addressable market for tumor HI is estimated to be approximately 3,000 patients in the U.S. annually, with 60% managed at National Cancer Institutes [158]. - Ersodetug has shown substantial reductions in GIR, leading to improved management of hypoglycemia in patients, with treatment durations ranging from several months to nearly 2 years [149]. - The company maintains an EAP for various HI indications, providing ersodetug on a compassionate use basis when other options have failed [148].