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Aileron Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights Announced promising safety and positive biomarker data from Cohort 2 (5mg BID) of the Phase 1b clinical trial of LTI-03 in

Key Takeaway: Aileron Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights Announced promising safety and positive biomarker data from Cohort 2 (5mg BID) of the Phase 1b clinical trial of LTI-03 in idiopathic pulmonary fibrosis (IPF) patients demonstrating

Full Press Release Details

Aileron Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Announced promising safety and positive biomarker data from Cohort 2 (5mg BID) of the Phase 1b clinical trial of LTI-03 in idiopathic pulmonary fibrosis (IPF) patients demonstrating dose dependent effects in five biomarkers evaluated compared to low dose LTI-03
Data from Cohort 2 of the Phase 1b clinical trial confirms results from Cohort 1, with four biomarkers achieving statistical significance in
the combined Cohort 1 and Cohort 2 data set
Planning is underway for a Phase 2 clinical trial
AUSTIN, Texas, Nov. 14, 2024 (PR 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 reported financial
results for the third quarter ended September 30, 2024, and provided a business update.
This past quarter has been one of significant progress
for Aileron, as evidenced by our recent announcement of positive data from Cohort 2 of our Phase 1b clinical trial evaluating a higher dose of LTI-03 (5 mg BID) in patients with IPF, in which high dose LTI-03 demonstrated dose dependent effects in five biomarkers, said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. We were highly encouraged that the combined data set from
Cohort 1 and 2 achieved statistical significance in four out of eight biomarkers evaluated in the trial, which along with promising safety and tolerability data, reinforce the potential of LTI-03 to improve
lung function and reverse the course of the disease.
Third Quarter 2024 Highlights and Recent Updates
Third Quarter 2024 Financial Results
About Aileron Therapeutics
Aileron Therapeutics is a
biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications.
Aileron s lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. LTI-03 completed a Phase 1b clinical trial for the treatment of idiopathic pulmonary fibrosis. Aileron s second product candidate, LTI-01, is a proenzyme that has
completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US.
Forward-Looking Statements
This press release may contain forward-looking statements of Aileron Therapeutics, Inc. ( Aileron , the Company , we ,
our or us ) within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to: the timing and expectation of a Phase 2 trial of LTI-03;
future expectations, plans and prospects for the Company; the sufficiency of the Company s cash resources; the projected cash runway of the Company; and the potential commercial opportunity of LTI-03 and LTI-01. We use words such as anticipate, believe, estimate, expect, hope, intend, may, plan, predict,
project, target, potential, would, can, could, should, continue, and other words and terms of similar meaning to help identify forward-looking
statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and
uncertainties related to: changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and
development, such as: adverse results in the Company s drug discovery; preclinical and clinical development activities; the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials,
including in a Phase 2 trial of LTI-03, or that partial results of a trial will be indicative of the full results of the trial; the Company s ability to enroll patients in its clinical trials; and the
risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the U.S. Food and Drug Administration and other regulatory authorities; investigational review boards at clinical trial sites and
publication review bodies with respect to the our development candidates; our ability to obtain, maintain and enforce intellectual property rights for our platform and development candidates; competition; the sufficiency of the Company s cash
resources to fund its planned activities for the periods anticipated and the Company s ability to manage unplanned cash requirements; and general economic and market conditions; as well as the risks and uncertainties discussed in the Risk
Factors section of the Company s Annual Report on Form 10-K for the year ended December 31, 2023, and the Quarterly Report on Form 10-Q for the quarter
ended September 30, 2024, which are on file with the United States Securities and Exchange Commission (the SEC ) and in subsequent filings that the Company files with the SEC. These forward-looking statements should not be relied
upon as representing the Company s view as of any date subsequent to the date of this press release, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or
otherwise, except as required by law.
Investor Relations & Media Contact:
Aileron Therapeutics, Inc.
September 30, 2024 December 31, 2023
Cash and cash equivalents $ 17,652 $ 17,313
Working capital 13,025 13,881
Total assets 104,217 106,008
Accumulated deficit (310,419 ) (288,517 )
Total stockholders equity $ 50,227 $ 6,887
Aileron Therapeutics, Inc.
Condensed Consolidated Statement of Operations
(In thousands, except
share and per share data)
Three Months Ended September 30,
2024 2023
Revenue $ $
Operating expenses:
Research and development 3,722 22
General and administrative 2,349 1,955
Restructuring and other costs 6
Total operating expenses 6,071 1,983
Loss from operations (6,071 ) (1,983 )
Other income, net 224 156
Net loss (5,847 ) (1,827 )
Net loss per share basic and diluted $ (0.27 ) $ (0.40 )
Weighted average common shares outstanding basic and diluted 21,663,089 4,541,167
Last updated: Nov 14, 2024