Company Overview - Aileron Therapeutics, Inc. is a biopharmaceutical company focused on developing first-in-class medicines for orphan pulmonary and fibrosis indications [4] - The lead product candidate, LTI-03, is a synthetic peptide targeting alveolar epithelial cell survival and inhibiting profibrotic signaling, currently in a Phase 1b clinical trial for idiopathic pulmonary fibrosis [4] - Aileron's second product candidate, LTI-01, has completed Phase 1b and Phase 2a trials for loculated pleural effusions and has received Orphan Drug Designation in the US and EU, as well as Fast Track Designation in the US [4] Market Position - Aileron is set to join the Russell Microcap® Index effective July 1, 2024, which reflects the company's market capitalization and growth potential [1][2] - Membership in the Russell Microcap® Index provides automatic inclusion in relevant growth and value style indexes, enhancing visibility among investment managers and institutional investors [1][2] Clinical Progress - The inclusion in the Russell Microcap Index is seen as a significant milestone, indicative of the clinical progress made with LTI-03, particularly positive data from Cohort 1 of the Phase 1b trial [2] - The trial reported statistically significant biomarker movement in three out of eight markers, suggesting LTI-03's potential to improve lung function and alter the disease course [2] Industry Context - Russell indexes are widely utilized by investment managers and institutional investors, serving as benchmarks for approximately $10.5 trillion in assets as of December 2023 [2] - FTSE Russell, the provider of these indexes, is recognized for its comprehensive range of reliable and accurate indexes that assist investors in measuring and benchmarking market performance [5]

Financial Performance - Aileron Therapeutics reported a net loss of $7.1 million for Q1 2024, compared to a net loss of $4.8 million in Q1 2023, with a net loss per share of $0.86 versus $1.05 in the prior year[7]. - Cash and cash equivalents decreased to $12.0 million as of March 31, 2024, down from $17.3 million at the end of 2023, but are expected to fund operations into the second half of 2025 after a recent financing[6]. - The total assets of Aileron as of March 31, 2024, were $99.2 million, down from $106.0 million at the end of 2023[11]. - The accumulated deficit increased to $295.6 million as of March 31, 2024, compared to $288.5 million at the end of 2023[11]. Expenses - Research and Development (R&D) expenses increased to $3.5 million in Q1 2024, up from $1.8 million in Q1 2023, primarily due to the acquisition of Lung Therapeutics[6]. - General and Administrative (G&A) expenses rose to $3.7 million in Q1 2024, compared to $2.2 million in Q1 2023, largely driven by increased professional fees and employee-related expenses[6]. Clinical Trials - Aileron announced positive data from Cohort 1 of the Phase 1b clinical trial of LTI-03 in idiopathic pulmonary fibrosis (IPF), with statistical significance achieved in three out of eight biomarkers evaluated[2]. - The company expects topline results from Cohort 2 of the Phase 1b study of LTI-03 in Q3 2024[2]. Financing Activities - Aileron closed a direct offering of 4,273,505 shares, raising approximately $20 million in gross proceeds, with potential additional proceeds from warrant exercises[3]. Product Development - Aileron's lead product candidate, LTI-03, is being evaluated for its potential to improve lung function and reverse the course of IPF[8].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol Name of each exchange on which registered Common Stock, $0.001 par value per share ALRN The Nasdaq Capital Market Emerging growth company ☐ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transiti ...

AUSTIN, Texas, May 03, 2024 (GLOBE NEWSWIRE) -- Aileron Therapeutics, Inc. ("Aileron") (NASDAQ:ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced the closing of its previously announced underwritten registered direct offering priced at-the-market under Nasdaq rules of 4,273,505 shares of its common stock and accompanying warrants to purchase an aggregate of 4,273,50 ...

AUSTIN, Texas, May 01, 2024 (GLOBE NEWSWIRE) -- Aileron Therapeutics, Inc. ("Aileron") (NASDAQ:ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced the pricing of an underwritten registered direct offering priced at-the-market under Nasdaq rules of 4,273,505 shares of its common stock and accompanying warrants to purchase an aggregate of 4,273,505 shares of common sto ...

Low-dose LTI-03 (2.5 mg BID), a Caveolin-1 related peptide, reduced expression of multiple profibrotic proteins in both pathological basal-like cells and fibroblasts and increased the expression of a biomarker indicative of epithelial health, suggesting potential therapeutic effect Positive trend was observed in seven of eight IPF biomarkers evaluated Low-dose LTI-03 was well-tolerated, with no safety signal observed Data from Cohort 2 evaluating high-dose LTI-03 (5 mg BID) is expected in the third quarter ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38130 | --- | --- | |---------------------------------------------------------------------------------------------------------------- ...

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]

WALTHAM, Mass., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Aileron Therapeutics, Inc. ("Aileron") (NASDAQ:ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, will host a virtual key opinion leader event today from 4:30 to 5:30 p.m. ET titled "Clinical Perspectives on Treating Idiopathic Pulmonary Fibrosis" featuring pulmonary care experts Fernando J. Martinez, M.D., M.S. from Weill Cornell M ...

Core Insights - Aileron Therapeutics is hosting a virtual key opinion leader event focused on treating Idiopathic Pulmonary Fibrosis on February 15, 2024 [1] - The event will feature discussions on emerging therapies, particularly Aileron's lead product candidate, LTI-03, which targets alveolar epithelial cell survival and inhibits profibrotic signaling [1][3] - Aileron's LTI-03 is currently in a Phase 1b clinical trial, with topline results expected by the end of Q2 2024 [3] Company Overview - Aileron Therapeutics is a biopharmaceutical company developing first-in-class medicines for orphan pulmonary and fibrosis indications [3] - The company’s second product candidate, LTI-01, has completed Phase 1b and Phase 2a clinical trials and has received Orphan Drug Designation in the US and EU, as well as Fast Track Designation in the US [3]