Estrella Immunopharma(US:ESLA)2025-11-12 21:08Financial Performance - The net loss for the three months ended September 30, 2025, was approximately $4.8 million, compared to a net loss of $3.4 million for the same period in 2024, indicating a 41% increase in losses [176]. - Estrella's accumulated deficit as of September 30, 2025, was approximately $36.4 million [163]. - The company reported a net cash used in operating activities of approximately $1.6 million for the nine months ended September 30, 2025, primarily due to a net loss of approximately $12.5 million [192]. Research and Development Expenses - Estrella has incurred approximately $4.2 million in research and development expenses for the three months ended September 30, 2025, compared to $2.8 million for the same period in 2024, reflecting a 50% increase [173]. - For the nine months ended September 30, 2025, research and development expenses totaled approximately $10.2 million, up from $6.4 million in 2024, representing a 59% increase [177]. - The company expects significant increases in expenses as it continues research and development and seeks marketing approval for its product candidates [183]. Cash and Liabilities - As of September 30, 2025, Estrella had cash of approximately $1.6 million and a working capital deficit of approximately $11.3 million [181]. - As of September 30, 2025, Estrella has accrued approximately $12.9 million in liabilities related to dosing milestones for the STARLIGHT-1 clinical trial [161]. - The company has accrued approximately $12.9 million in liabilities related to milestones achieved as of September 30, 2025, including the completion of nine patients' dosing and a second site activation milestone [203]. Capital and Financing - The company plans to raise additional capital to fund research and development programs, but there is no assurance that financing will be available on acceptable terms [191]. - Net cash provided by financing activities was approximately $2.3 million for the nine months ended September 30, 2025, primarily from a private placement [194]. - As of September 30, 2025, the company had issued 70,000 Equity Line Shares to White Lion for an aggregate consideration of $79,491 under the Common Stock Purchase Agreement [189]. Clinical Trial Obligations - The total fees for the clinical trial services under Statement of Work No. 001 with Eureka amount to $33.0 million for achieving all milestones [161]. - The company has a total fee obligation of $33.0 million to Eureka for the Phase I/II clinical trial of its product candidate, EB103 [202]. - The company has fully paid the $1.0 million license fee to Eureka and earned two development milestones, with payments of $50,000 each for the IND submission and first patient dosed [199]. Legal and Contingencies - The company is subject to loss contingencies, including legal proceedings and claims, which may require accruals when a liability is probable and can be reasonably estimated [197]. General and Administrative Expenses - The company incurred approximately $649,000 in general and administrative expenses for the three months ended September 30, 2025, compared to $551,000 for the same period in 2024, reflecting an increase of 18% [175]. Derivative Liabilities - The fair value of the derivative liability related to the True-Up Shares was valued at $385,355 as of September 30, 2025, using a Monte Carlo Simulation model [207]. Revenue Generation - Estrella has not generated any revenue since its inception and does not expect to do so for at least the next few years [182].