Core Insights - Aileron Therapeutics has completed enrollment in Cohort 2 of its Phase 1b clinical trial for LTI-03, targeting idiopathic pulmonary fibrosis (IPF) patients [1][2] - The trial aims to evaluate the safety and tolerability of high-dose LTI-03 (5 mg BID) after positive trends were observed in Cohort 1 with low-dose LTI-03 (2.5 mg BID) [1][2] - The company expects to report topline data from Cohort 2 in the near term [2] Company Overview - Aileron Therapeutics is focused on developing first-in-class medicines for unmet medical needs in orphan pulmonary and fibrosis indications [6] - The lead product candidate, LTI-03, is a synthetic peptide designed to target alveolar epithelial cell survival and inhibit profibrotic signaling [6][7] - 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 [7] Clinical Trial Details - The Phase 1b trial is a randomized, double-blind, placebo-controlled study involving 24 patients, with a 3:1 randomization to receive either LTI-03 or placebo [2][3] - The primary objective is to assess safety and tolerability over 14 days, with exploratory endpoints measuring multiple protein biomarkers [3] Disease Context - IPF is a chronic lung disease characterized by progressive tissue scarring, affecting approximately 100,000 people in the United States, typically presenting in adults aged 65 or older [4] - The disease is usually fatal within two to five years after diagnosis [4] Mechanism of Action - LTI-03 is derived from the caveolin scaffolding domain (CSD) of the Cav1 protein, which plays a critical role in preventing fibrosis [5] - Cav1 expression is decreased in IPF lung tissues, and restoring its balance may slow lung function decline and protect healthy epithelial cells [5]

Company Overview - Aileron Therapeutics is a biopharmaceutical company focused on developing first-in-class medicines for significant unmet medical needs in orphan pulmonary and fibrosis indications [2] - 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 [2] - Aileron's second product candidate, LTI-01, has completed Phase 1b and Phase 2a clinical 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 [2] Upcoming Events - Brian Windsor, Ph.D., President and CEO of Aileron, will present at the 8th Annual IPF Summit on August 21, 2024, discussing biomarker strategies in the clinical development of LTI-03 [1] - The IPF Summit is a major drug development initiative for the pulmonary fibrosis community, featuring participation from key biopharmaceutical companies, clinicians, and academic researchers [1]

Core Insights - Aileron Therapeutics announced positive data from Cohort 1 of the Phase 1b clinical trial for LTI-03 in idiopathic pulmonary fibrosis (IPF), showing positive trends in seven out of eight evaluated biomarkers [1][4] - The company raised approximately $18.2 million in net proceeds from a registered direct offering to support the ongoing clinical trials [2][3] - Topline results from Cohort 2, which evaluates a higher dose of LTI-03, are expected in the third quarter of 2024 [1][4] Corporate Updates - Aileron completed an underwritten registered direct offering of 4,273,505 shares, raising net proceeds of approximately $18.2 million [3] - The company has the potential to receive an additional $20 million from the exercise of warrants issued in the offering [3] - The focus for the first half of 2024 was on strengthening the balance sheet and advancing the development of inhaled LTI-03 for IPF [2] Pipeline Developments - Positive results from Cohort 1 of the Phase 1b trial indicated LTI-03's potential to inhibit fibrosis and improve lung function, with statistical significance achieved in three biomarkers [2][4] - LTI-03 was well-tolerated, with no serious adverse events reported during the trial [4] - The ongoing Phase 1b trial aims to further validate LTI-03's efficacy in treating IPF [2][4] Financial Performance - As of June 30, 2024, Aileron reported cash and cash equivalents of $21.9 million, an increase from $12.0 million as of March 31, 2024 [6] - Research and Development (R&D) expenses for Q2 2024 were $3.7 million, significantly higher than $0.2 million in Q2 2023, primarily due to the acquisition of Lung Therapeutics, Inc. [7] - General and Administrative (G&A) expenses rose to $5.3 million in Q2 2024 from $1.9 million in Q2 2023, driven by increased professional fees and employee-related expenses [8] Key Financial Metrics - The net loss for Q2 2024 was $8.9 million, compared to $1.8 million in Q2 2023, with a basic and diluted net loss per share of $0.45 [8][13] - Total assets as of June 30, 2024, were $109.4 million, with an accumulated deficit of $304.6 million [12]

Exhibit 99.1 Aileron Therapeutics Reports Second Quarter 2024 Financial Results and Business Highlights Announced positive data from Cohort 1 of the ongoing Phase 1b clinical trial of LTI-03 evaluating low dose LTI-03 (2.5 mg BID) in idiopathic pulmonary fibrosis ("IPF") patients, with positive trends observed in seven of the eight biomarkers evaluated Topline results from Cohort 2 evaluating high-dose LTI-03 (5 mg BID) expected in the third quarter of 2024 AUSTIN, Texas, Aug 14, 2024 (PR NEWSWIRE) – Ailero ...

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 June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transitio ...

AUSTIN, Texas, July 30, 2024 /PRNewswire/ -- 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 that Brian Windsor, Ph.D., President and Chief Executive Officer, will present at the Canaccord Genuity 44th Annual Growth Conference on Tuesday, August 13, 2024 at 4:00 p.m. EDT in Boston, MA.A live webcast of the event can ...

AUSTIN, Texas, July 1, 2024 /PRNewswire/ -- Aileron Therapeutics, Inc. ("Aileron" or the "Company") (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 that the Company is set to join the Russell Microcap® Index at the conclusion of the 2024 Russell U.S. Indexes annual reconstitution, effective at the open of US equity markets on Monday, July 1, 2024.The ann ...

Aileron Therapeutics Reports First Quarter 2024 Financial Results and Business Highlights Announced positive data from Cohort 1 of the Phase 1b clinical trial of LTI-03 in idiopathic pulmonary fibrosis (IPF) patients with positive trends observed in seven of the eight biomarkers evaluated Topline results from Cohort 2 evaluating high-dose LTI-03 (5 mg BID) expected in the third quarter of 2024 AUSTIN, Texas, May 15, 2024 (GLOBE NEWSWIRE) – Aileron Therapeutics, Inc. ("Aileron" or the "Company") (NASDAQ: ALR ...

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 ...