On April 15, 2024 Aileron Therapeutics, Inc. ("Aileron", the "Company", "we", "our" or "us") (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, reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update (Press release, Aileron Therapeutics, APR 15, 2024, View Source [SID1234642064]).
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"We ended the year in a solid position after the successful completion of our merger with Lung Therapeutics, which provided a focused pipeline of promising clinical-stage candidates for life-threatening lung conditions, coupled with a strengthened balance sheet from the successful closure of a $18.4 million financing," said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. "We anticipate 2024 as a pivotal year of execution as we continue to progress our lead product candidate, LTI-03. We expect to report topline results from the ongoing Phase 1b study of LTI-03 in the third quarter of this year. LTI-03 and its potential dual mechanism of action on both epithelial cells and fibroblasts is gaining support from the medical community, and we look forward to building upon encouraging preclinical data that LTI-03 has the potential to protect healthy lung epithelial cells and to reduce pro-fibrotic signaling."
Recent Business Highlights and Upcoming Milestones
Corporate Updates
In October 2023, Aileron acquired Lung Therapeutics, Inc. ("Lung"), shifting the Company’s disease focus to advance a pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis diseases. The Company’s lead clinical programs include LTI-03 for idiopathic pulmonary fibrosis (IPF) and LTI-01 for loculated pleural effusion (LPE).
Immediately following the closing of Aileron’s acquisition of Lung ("Lung Acquisition"), the Company entered into a definitive agreement for the sale of shares of its Series X non-voting convertible preferred stock and warrants to purchase shares of Aileron common stock in a private placement to a group of accredited investors led by Bios Partners, the majority stockholder of Lung prior to the Lung Acquisition, and including Nantahala Capital, as well as additional undisclosed investors. The private placement resulted in gross proceeds to Aileron of approximately $18 million before deducting placement agent fees and other offering expenses.
In March 2024, the Company announced the appointment of Brian Windsor, Ph.D., as President and Chief Executive Officer and to the Board of Directors. Dr. Windsor previously served as Aileron’s Chief Operating Officer and President, and Chief Executive Officer and director of Lung.
Pipeline
In February 2024, Aileron hosted a pulmonary care expert panel to discuss the potential implications of LTI-03 for IPF, featuring pulmonary care experts Fernando J. Martinez, M.D., M.S., Chief of the Pulmonary and Critical Care Medicine Division at Weill Cornell Medicine; Tejaswini Kulkarni, M.D., M.P.H., Associate Professor of Pulmonology, Allergy and Critical Care Medicine and Director of the Interstitial Lung Disease Program at University of Alabama at Birmingham Medicine; and Andreas Günther, M.D., Senior Physician of Pulmonology and Intensive Care Medicine and Chief Physician of Pulmonology and Internal Intensive Care Medicine at Agaplesion Evang. Central Hesse Hospital and Professor of Interstitial and Rare Lung Diseases at Justus Liebig University. A replay of the event can be accessed at View Source
LTI-03: a novel Caveolin-1-related (Cav1) peptide with a dual mechanism targeting both alveolar epithelial cell survival as well as inhibition of profibrotic signaling
LTI-03 is currently in a randomized, double-blind, placebo-controlled Phase 1b clinical trial in IPF patients. Aileron expects to report topline results from this trial in the third quarter of 2024.
LTI-01: a PAI-1 resistant plasmin activated proenzyme for loculated pleural effusions
LTI-01 has been evaluated in Phase 1b and Phase 2a clinical trials in patients with infected, non-draining LPEs and is ready for Phase 2b. LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US.
Fourth Quarter and Full Year 2023 Financial Results
Cash Position: Cash, cash equivalents, and investments on December 31, 2023, were $17.3 million, compared to $21.2 million on December 31, 2022. Based on its current operating plan, the Company expects its existing cash, cash equivalents, and investments will fund operations into the fourth quarter of 2024.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended December 31, 2023, were $2.0 million, compared to $2.4 million for the quarter ended December 31, 2022. R&D expenses decreased primarily due to the termination of R&D activities related to ALRN-6924. R&D expenses for the full-year 2023 were $4.0 million, compared to $18.0 million for the prior year.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended December 31, 2023, were $5.3 million compared to $2.3 million for the quarter ended December 31, 2022. G&A expenses increased due to the integration and operating activities of Lung. G&A expenses for the full-year 2023 were $11.4 million, compared to $9.7 million for the prior year.
Net Loss: Net loss for the quarter ended December 31, 2023, was $7.3 million, compared to $4.5 million for the quarter ended December 31, 2022. The basic and diluted net loss per share for the quarter ended December 31, 2023 was $1.54 compared to $1.00 for the quarter ended December 31, 2022. The basic and diluted net loss per share for the full-year 2023 was $3.42 compared to $6.02 for the full-year 2022.