Aileron Therapeutics(ALRN) - 2025 Q1 - Quarterly Report

Financial Performance - The company reported net losses of $5.5 million for Q1 2025, compared to$7.1 million for Q1 2024, with an accumulated deficit of $356.9 million as of March 31, 2025[145]. - The net loss for the three months ended March 31, 2025 was$5.5 million, an improvement of 22.7% compared to a net loss of $7.1 million in the same period of 2024[165]. - During the three months ended March 31, 2025, net cash used in operating activities was$6.2 million, compared to $5.3 million in the same period of 2024, indicating an increase of 17.0$7.4 million, which is expected to fund operations only until September 2025[147]. - As of March 31, 2025, the company had cash and cash equivalents of $7.4 million, which is expected to fund operations into September 2025[172]. - The company raised$1.7 million from the exercise of PIPE Warrants and Offering Warrants on April 21, 2025[174]. Research and Development - The company initiated the RENEW Phase 2 clinical trial of LTI-03 in May 2025, aiming to enroll approximately 120 patients across up to 50 sites globally[141]. - The RENEW trial will assess the safety and efficacy of LTI-03, with a primary endpoint focused on treatment-emergent adverse events over 24 weeks[142]. - The company plans to continue its research and development of LTI-03 and LTI-01, expecting substantial increases in expenses related to ongoing activities[184]. Operating Expenses - For the three months ended March 31, 2025, total operating expenses decreased to $5.6 million from$7.2 million in the same period of 2024, representing a reduction of approximately 22.1%[165]. - Research and development expenses for the three months ended March 31, 2025 were $3.1 million, down from$3.5 million in the same period of 2024, a decrease of 11.4% primarily due to delays in clinical development[166]. - General and administrative expenses decreased to $2.5 million for the three months ended March 31, 2025, compared to$3.7 million in 2024, reflecting a reduction of 32.4% mainly from decreased professional fees[169]. Financing Activities - The company has financed operations through $145.5 million in net proceeds from common stock sales and$17.7 million from a public offering in May 2024[144]. - The company completed a follow-on public offering in May 2024, raising net proceeds of $17.7 million from the sale of 4,273,505 shares[154]. - The company entered into an "at the market offering" agreement with H.C. Wainwright for an aggregate offering price of up to$13.7 million[148]. - The company anticipates needing additional capital to fund operations, which may be obtained through equity or debt financings, strategic collaborations, or licensing arrangements[171]. Accounting and Compliance - No material changes to critical accounting estimates were reported for the three months ended March 31, 2025[192]. - Recent accounting standards reviewed will not have a material impact on the condensed consolidated financial statements[193]. - The company qualifies as a smaller reporting company and is not required to provide certain market risk disclosures[194]. Future Outlook - The company anticipates continued operating losses due to ongoing research and development activities[146]. - The company has a total potential obligation of approximately $16.9 million under a master services agreement with a third-party CRO for clinical research[189]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[155].