Aileron Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Core Insights - Aileron Therapeutics is advancing a novel pipeline of first-in-class medicines targeting significant unmet medical needs in orphan pulmonary and fibrosis indications, with a focus on LTI-03 for idiopathic pulmonary fibrosis (IPF) and LTI-01 for loculated pleural effusion (LPE) [1][3][7] Financial Performance - As of December 31, 2023, the company reported cash, cash equivalents, and investments of $17.3 million, down from $21.2 million in 2022, with expectations to fund operations into the fourth quarter of 2024 [6][10] - Research and Development (R&D) expenses for Q4 2023 were $2.0 million, a decrease from $2.4 million in Q4 2022, primarily due to the termination of R&D activities related to ALRN-6924 [6][11] - General and Administrative (G&A) expenses for Q4 2023 were $5.3 million, up from $2.3 million in Q4 2022, attributed to the integration and operating activities of Lung [6][11] - The net loss for Q4 2023 was $7.3 million, compared to $4.5 million in Q4 2022, with a basic and diluted net loss per share of $1.54 [6][11] Business Developments - The successful merger with Lung Therapeutics in October 2023 has provided a focused pipeline and strengthened the balance sheet with $18.4 million in financing [2][3] - The company anticipates 2024 to be a pivotal year, expecting to report topline results from the Phase 1b study of LTI-03 in Q3 2024 [2][4] - LTI-03 is currently in a randomized, double-blind, placebo-controlled Phase 1b clinical trial for IPF patients, with a dual mechanism targeting both epithelial cells and fibroblasts [4][7] Pipeline Overview - LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US, and is ready for Phase 2b trials after evaluations in Phase 1b and Phase 2a [5][7] - Aileron hosted a pulmonary care expert panel in February 2024 to discuss LTI-03's implications for IPF, featuring notable pulmonary care experts [4]