Aileron Therapeutics(US:ALRN)2025-11-14 13:00Financial Performance - The company reported net losses of $5.6 million and $5.8 million for the three months ended September 30, 2025 and 2024, respectively, and $17.9 million and $21.9 million for the nine months ended September 30, 2025 and 2024, respectively [182]. - The company has incurred significant losses since inception, with an accumulated deficit of $369.3 million as of September 30, 2025 [182]. - The company has not generated any revenue from product sales and has never achieved an operating profit [180]. - The company did not generate any revenue from product sales and does not expect to do so in the foreseeable future [204]. - The company faces substantial doubt about its ability to continue as a going concern due to lack of revenue and recurring net losses [227]. Cash and Financing - As of September 30, 2025, the company had cash and cash equivalents of $4.0 million, which is insufficient to fund operations beyond December 2025 without additional capital [183]. - The company raised $7.4 million through financing activities in 2025, primarily from the April 2025 Transactions and Yorkville Transactions [230]. - The company has raised $145.5 million in net proceeds from sales of common stock and warrants, and $131.2 million from sales of preferred stock prior to its IPO [181]. - Under the Standby Equity Purchase Agreement, the company may sell up to $15.0 million of common stock to Yorkville over a 36-month period [189]. - The company entered into a Pre-Paid Advance Agreement allowing for up to $6.0 million in pre-paid advances, with an initial advance of $1.0 million already received [185]. Operating Expenses - In the three months ended September 30, 2025, the company reported research and development expenses of $1.7 million, a decrease of $2.0 million from $3.7 million in the same period in 2024 [217]. - General and administrative expenses increased to $3.8 million for the three months ended September 30, 2025, compared to $2.3 million in 2024, primarily due to increased professional fees [218]. - The total operating expenses for the three months ended September 30, 2025, were $5.5 million, down from $6.1 million in 2024, resulting in a loss from operations of $5.5 million [216]. - For the nine months ended September 30, 2025, research and development expenses totaled $9.0 million, down from $10.9 million in 2024, reflecting a decrease of $1.9 million [222]. - Total operating expenses for the nine months ended September 30, 2025, were $18.0 million, a decrease of $4.3 million from $22.3 million in 2024 [221]. - General and administrative expenses decreased by $2.5 million to $8.9 million for the nine months ended September 30, 2025, compared to $11.4 million for the same period in 2024 [223]. Clinical Development - The FDA lifted the clinical hold on the Phase 2 RENEW trial for LTI-03, allowing the company to resume patient recruitment in late 2025 or early 2026 [179]. - The RENEW trial is designed to enroll approximately 120 patients with Idiopathic Pulmonary Fibrosis (IPF) across up to 50 sites globally, with initial topline data expected in Q3 2026 [179]. - The company has two product candidates in clinical development: LTI-03 and LTI-01, with LTI-03 currently being prioritized for development [174]. - The company anticipates significant increases in research and development and general administrative costs as it advances clinical development of its product candidates [231]. - A master services agreement for clinical research with a third-party CRO was terminated in August 2025, with no future commitments [236]. Cash Flow - Net cash used in operating activities was $16.1 million for the nine months ended September 30, 2025, compared to $17.5 million for the same period in 2024 [229]. - Cash provided by financing activities was $7.4 million for the nine months ended September 30, 2025, down from $17.8 million in the same period of 2024 [230]. - As of September 30, 2025, the company had cash and cash equivalents of $4.0 million, which is expected to fund operations into December 2025 [226].