Rezolute(US:RZLT)2025-11-06 21:29Financial Performance - The company reported a net loss of $18,150,000 for the three months ended September 30, 2025, compared to a net loss of $15,378,000 for the same period in 2024, representing an increase in loss of about 18.1%[14]. - The company reported a comprehensive loss of $18,094,000 for the three months ended September 30, 2025, compared to a comprehensive loss of $15,010,000 in the same period of 2024, indicating an increase of approximately 20.7%[14]. - Total net loss for Q3 2025 was $18,150,000, compared to a net loss of $15,378,000 in Q3 2024, representing a 17.9% increase in net loss year-over-year[111]. - Cash used in operating activities for the three months ended September 30, 2025, amounted to $17.4 million, compared to $16.0 million for the same period in 2024, reflecting a net loss increase from $15.4 million to $18.2 million[175]. - Cash provided by financing activities was $0.9 million for the three months ended September 30, 2025, a decrease from $5.5 million in 2024[180]. Expenses - Operating expenses increased to $19,817,000 for the three months ended September 30, 2025, up from $16,941,000 in the prior year, marking a rise of approximately 16.7%[14]. - Research and development expenses rose to $13,149,000 for the three months ended September 30, 2025, compared to $12,754,000 in the prior year, reflecting an increase of about 3.1%[14]. - General and administrative (G&A) expenses for the three months ended September 30, 2025 were $6,668,000, a 59% increase from $4,187,000 in 2024[156]. - The increase in G&A expenses was primarily due to a $1.1 million rise in G&A compensation and benefits and a $1.4 million increase in other G&A costs related to business development[156]. - Share-based compensation expense for the three months ended September 30, 2025, totaled $2.531 million, an increase from $1.400 million in the same period of 2024[81]. Assets and Liabilities - Total current assets decreased from $171,145,000 as of June 30, 2025, to $154,708,000 as of September 30, 2025, a decline of approximately 9.6%[12]. - The company’s total liabilities decreased from $13,363,000 as of June 30, 2025, to $11,496,000 as of September 30, 2025, a decline of approximately 13.9%[12]. - As of September 30, 2025, the company had an accumulated deficit of $422.0 million, with cash and cash equivalents of $9.1 million and short-term investments in marketable debt securities of $143.1 million[36]. - The company has total liabilities of $11.5 million, including current liabilities of $10.2 million as of September 30, 2025[37]. - The fair value of the Company's cash and cash equivalents was approximately $147.5 million as of September 30, 2025, with $4.4 million in money market funds and $143.1 million in marketable debt securities[98]. Capital Resources and Funding - The company raised approximately $96.8 million in net proceeds from the 2025 Underwritten Offering, which included the issuance of 20,786,923 shares of common stock at a price of $3.25 per share[61]. - The company completed a private placement in May 2025, resulting in net proceeds of $4.2 million from the issuance of 1,295,383 shares at a purchase price of $3.25 per share[60]. - The company expects its cash and cash equivalents and investments in marketable debt securities to be adequate to meet its contractual obligations for at least 12 months from the issuance date of the financial statements[41]. - The company has incurred cumulative net losses of $422.0 million since inception and has not generated any meaningful revenue to date[160]. - Long-term contractual obligations include a regulatory milestone payment of $25.0 million payable to XOMA and additional payments up to $25.0 million payable to ActiveSite[164]. Research and Development - The company is focused on developing ersodetug, a potential treatment for hyperinsulinism, indicating ongoing commitment to research and development in rare diseases[22]. - The company aims to complete the sunRIZE study by December 2025 and submit a Biologics License Application for ersodetug in mid-2026[121]. - The upLIFT Phase 3 study for tumor hyperinsulinism is expected to yield topline results in the second half of 2026[130]. - Ersodetug has shown substantial improvement in hypoglycemia management for patients with refractory conditions, with no discontinuations due to lack of response or safety[134]. - Six patients with congenital hyperinsulinism are currently receiving ersodetug under the Expanded Access Program, with treatment durations ranging from one to three years[135]. Market and Commercialization - The addressable market for congenital hyperinsulinism in the U.S. is estimated to be over 1,500 individuals[122]. - The company did not generate any revenue for the three months ended September 30, 2025 and 2024, remaining in a late stage of clinical development without commercial products[152]. - Future commercialization of product candidates may require additional milestone payments and royalties totaling up to $202.5 million, contingent on successful regulatory approvals[165]. Stock and Equity - The weighted average number of common shares outstanding increased from 69,736,150 in 2024 to 103,422,647 in 2025, an increase of approximately 48.3%[14]. - The company had a total of 15,462,163 shares authorized under its equity incentive plans as of September 30, 2025, with 14,477,087 shares outstanding[71]. - The company had 1,081,500 unvested Restricted Stock Units (RSUs) at the end of September 2025, with an aggregate fair value of approximately $0.2 million for new grants[79][80]. - The company issued stock options for 740,000 shares during the three months ended September 30, 2025, with a weighted average exercise price of $7.71[74]. - The intrinsic value of outstanding stock options as of September 30, 2025, was approximately $72.7 million, with vested options having an intrinsic value of approximately $42.0 million[76]. Legal and Compliance - The company had no pending or threatened lawsuits that could materially affect its results of operations as of September 30, 2025[88]. - Management has determined that internal control over financial reporting was effective as of September 30, 2025[185].