Aileron Therapeutics Q2 2024 Financial Results and Highlights

Aileron Therapeutics, Inc., a biopharmaceutical company focused on developing first-in-class treatments for orphan pulmonary and fibrosis conditions, has disclosed its financial results for the second quarter ending June 30, 2024, and provided recent business updates. The company, trading on NASDAQ under the ticker ALRN, is progressing with its clinical trials and financial strategies.

In the initial half of the year, Aileron concentrated on bolstering its financial position and advancing the development of its inhaled drug candidate, LTI-03, for idiopathic pulmonary fibrosis (IPF). The company's President and CEO, Dr. Brian Windsor, highlighted the positive results from the first cohort of their Phase 1b clinical trial, which were announced in May 2024. This cohort tested a low dose of LTI-03 (2.5 mg twice daily) in IPF patients and showed statistically significant improvements in three out of eight biomarkers. This promising data suggests LTI-03's potential to inhibit fibrosis and enhance lung function. Furthermore, Aileron successfully raised $18.2 million through an underwritten registered direct offering in May. This infusion of capital will support the ongoing validation of LTI-03 in their Phase 1b trial, with topline results from the high-dose cohort anticipated in the third quarter of 2024.

Key corporate updates from the second quarter include the completion of the direct offering, which involved issuing over four million shares of common stock and warrants, resulting in net proceeds of $18.2 million. The company also stands to gain an additional $20 million from the exercise of these warrants.

On the pipeline front, Aileron reported positive data from Cohort 1 of their Phase 1b trial, which focused on the safety and tolerability of inhaled LTI-03. The trial involved twelve patients receiving a low dose of LTI-03, and seven out of eight biomarkers showed positive trends. Notably, LTI-03 reduced the expression of several profibrotic proteins in cells contributing to IPF progression, with significant decreases in three biomarkers. Additionally, LTI-03 boosted the production of solRAGE, a marker indicating the health of type I epithelial cells, which is crucial in IPF treatment. No serious adverse events were reported, indicating the drug's tolerability. The Phase 1b trial continues, with the high-dose cohort results expected in the third quarter.

In May, Aileron organized a call with pulmonary care expert Dr. Andreas Günther to discuss the Cohort 1 results. This event featured insights into the clinical outcomes and was made available for replay.

Aileron's financial results for the second quarter also reflect the company's growth and increased activity, particularly following their acquisition of Lung Therapeutics, Inc. in October 2023. The acquisition has significantly impacted their research and development (R&D) expenses, which rose to $3.7 million from $0.2 million in the same quarter the previous year. This increase is attributed to clinical trial costs, manufacturing expenses, consulting fees, and employee-related expenses linked to the clinical programs inherited from Lung Therapeutics.

General and administrative (G&A) expenses also saw a substantial rise to $5.3 million from $1.9 million, driven by higher professional fees and employee expenses due to increased business operations post-acquisition. Consequently, Aileron's net loss for the quarter amounted to $8.9 million compared to $1.8 million in the previous year, with the net loss per share at $0.45 versus $0.39.

As of June 30, 2024, Aileron had cash and cash equivalents totaling $21.9 million, an increase from $12.0 million at the end of March 2024. With the funds raised in May and based on current operational plans, the company expects its cash reserves to support the completion of the Phase 1b trial and sustain operations into the latter half of 2025.

Looking ahead, Aileron remains committed to developing its lead product candidate, LTI-03, a synthetic peptide aimed at improving alveolar epithelial cell survival and inhibiting profibrotic signaling in IPF. Additionally, their second candidate, LTI-01, targets loculated pleural effusions and has already progressed through Phase 1b and Phase 2a trials, earning Orphan Drug Designation in both the US and EU.