Aileron Therapeutics(ALRN)2025-04-07 20:02Financial Performance - The company has incurred net losses of $62.9 million and $15.7 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $351.4 million as of December 31, 2024[559]. - The net loss for the year ended December 31, 2024, was $62.9 million, compared to a net loss of $15.7 million in 2023, reflecting an increase in losses of $47.2 million[583]. - Cash used in operating activities was $22.3 million in 2024, compared to $19.8 million in 2023, indicating a higher cash burn rate[602]. - Other income for 2024 was $0.7 million, up from $0.5 million in 2023, primarily due to interest income and investment accretion[589]. Cash and Financing - As of December 31, 2024, the company had cash and cash equivalents of $12.9 million, which is expected to fund operations into August 2025, but is insufficient for completing the planned Phase 2 clinical trial of LTI-03[560]. - The company has financed operations primarily through $145.5 million in net proceeds from sales of common stock and warrants, and $17.7 million from a public offering completed in May 2024[558][565]. - Net cash provided by financing activities for the year ended December 31, 2024, was $17.8 million, an increase from $15.8 million in 2023 due to PIPE Financing[607]. - The company anticipates needing to raise additional capital through public or private equity offerings, debt financings, or collaborations[612]. Research and Development - The company has two product candidates in clinical development: LTI-03 for Idiopathic Pulmonary Fibrosis and LTI-01 for loculated pleural effusion, with LTI-01's clinical development temporarily delayed[556][561]. - Research and development expenses primarily consist of costs related to clinical trials, personnel, and compliance with regulatory requirements[572][576]. - Research and development expenses increased to $14.2 million in 2024 from $4.0 million in 2023, a rise of $10.3 million, primarily due to new clinical programs acquired in the Lung Acquisition[584]. - The company anticipates continued significant expenses and operating losses as it advances clinical development of lead product candidates LTI-03 and LTI-01[594]. - The company plans to continue research and development of LTI-03 and LTI-01, expecting substantial increases in expenses related to ongoing activities[608]. Impairment and Losses - The impairment loss on intangible assets was identified in the fourth quarter of 2024 when the carrying value of LTI-01 exceeded its fair value[577]. - The company incurred an impairment loss on intangible assets of $37.0 million in 2024, linked to the delay in clinical development of LTI-01[587]. - An impairment loss of $37.0 million was recognized for the LTI-01 intangible asset due to a temporary delay in clinical development[626]. General and Administrative Expenses - General and administrative expenses rose to $13.9 million in 2024 from $11.4 million in 2023, an increase of $2.5 million, mainly driven by higher employee-related expenses and costs associated with the Lung Acquisition[586]. Future Outlook - The company anticipates continued operating losses for the foreseeable future due to ongoing research and development costs[559]. - Future capital requirements will depend on various factors, including clinical trial costs and regulatory approval processes[610]. Other Information - The company has federal net operating loss carryforwards of $77.3 million and federal research and development tax credit carryforwards of $2.4 million as of December 31, 2024[590]. - The company does not have any off-balance sheet arrangements as of December 31, 2024, and 2023[614]. - The company is classified as a "smaller reporting company," which may allow it to rely on exemptions from certain disclosure requirements[635]. - Management continues to monitor estimates related to financial conditions and will adjust them as necessary based on changing economic conditions[627].