Aileron Therapeutics(US:ALRN)2025-08-14 20:03Financial Performance - The company reported net losses of $6.8 million and $8.9 million for the three months ended June 30, 2025, and 2024, respectively, with an accumulated deficit of $363.7 million as of June 30, 2025[166]. - The net loss for the three months ended June 30, 2025 was $6.8 million, an improvement of $2.1 million from a net loss of $8.9 million in the same period in 2024[194]. - The company has not generated any revenue from product sales and has never achieved an operating profit[163]. - The company anticipates continued significant operating losses and cash flow negative operations as it advances clinical development of its product candidates[203]. Cash and Financing - As of June 30, 2025, the company had cash and cash equivalents of $5.7 million, which is expected to fund operations only until November 2025[167]. - The company has financed operations primarily through $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[165]. - The company entered into privately negotiated letter agreements resulting in the cancellation of PIPE Warrants for an aggregate of 1,939,000 shares, generating total gross proceeds of $3.1 million[209]. - The company completed a Private Placement on April 24, 2025, raising total gross proceeds of $0.5 million at a price of $1.599 per share[210]. - The company reported net cash provided by financing activities of $5.5 million during the six months ended June 30, 2025, primarily from the April 2025 Transactions[220]. - The company may seek to finance operations through equity or debt financings, strategic collaborations, or licensing arrangements, which could impact existing stockholders[223]. - The company has entered into agreements allowing for the sale of up to $15.0 million of common stock to Yorkville over a 36-month period at its discretion[214]. Research and Development - The company initiated the RENEW Phase 2 clinical trial of LTI-03 in May 2025, aiming to enroll approximately 120 patients diagnosed with IPF across up to 50 sites globally[160]. - The RENEW Phase 2 trial was placed on clinical hold by the FDA on June 10, 2025, due to the lack of a No-Observed-Adverse-Effect Level (NOAEL) identified in prior studies[161]. - The company plans to activate trial sites and enroll patients in Australia, the UK, and Europe, with interim topline data expected in the first half of 2026, pending resolution of the clinical hold[162]. - For the three months ended June 30, 2025, the company reported research and development expenses of $4.3 million, an increase of $0.6 million from $3.7 million in the same period in 2024[195]. - Research and development expenses for the six months ended June 30, 2025 were $7.3 million, slightly up from $7.2 million in the same period in 2024[200]. - The company plans to continue research and development of LTI-03 and LTI-01, expecting substantial increases in expenses as preclinical activities and clinical trials advance[221]. Operating Expenses - The total operating expenses for the three months ended June 30, 2025 were $6.9 million, a decrease of $2.2 million compared to $9.0 million in the same period in 2024[194]. - General and administrative expenses decreased to $2.6 million for the three months ended June 30, 2025, down from $5.3 million in the same period in 2024, primarily due to reduced professional fees and employee turnover[197]. - The company has a potential obligation of approximately $17.0 million under a master services agreement with a third-party CRO for clinical research studies[226]. - The total potential obligation under a master services agreement with a third-party CRO for clinical research is approximately $17.0 million[178].