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 /PRNewswire/ -- Aileron Therapeutics, Inc.
("Aileron" or the "Company") (NASDAQ: ALRN), a biopharmaceutical company advancing a pipeline of potential first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today reported financial results for the second quarter ended June 30, 2024 , and provided a business update. "Throughout the first half of the year, we focused on strengthening our balance sheet and advancing the development of inhaled LTI-03 in IPF," said Brian Windsor , Ph.D.
, President and Chief Executive Officer of Aileron. "We are extremely pleased with the positive data from Cohort 1 of the ongoing Phase 1b clinical trial announced in May, particularly the achievement of statistical significance in three out of eight biomarkers which is a testament to the potential of LTI-03 to inhibit fibrosis and improve lung function. Additionally, in May, we raised approximately $18.
2 million in net proceeds in an underwritten registered direct offering, which provides us with the resources to further validate LTI-03 in the ongoing Phase 1b trial. We look forward to reporting topline results from the high-dose cohort in the third quarter of this year." Second Quarter 2024 Highlights and Recent Updates Corporate Updates Pipeline Second Quarter 2024 Financial Results About Aileron Therapeutics Aileron Therapeutics, Inc.
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. Currently, LTI-03 is being evaluated in 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 within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to: the timing and expectation of the topline results from Cohort 2 of the Phase 1b study of LTI-03; the sufficiency of the Company's cash resources; the projected cash runway of the Company; the status and plans for clinical trials, including the timing of data; future product development; 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 or that partial results of a trial such as the results from Cohort 1 of the Company's ongoing Phase 1b clinical trial of LTI -03 may not 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 Company's 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 Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 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: Argot Partners aileron@argotpartners.
com 212-600-1902 Aileron Therapeutics, Inc. Balance Sheet Data (Unaudited) (In thousands) June 30, 2024 December 31, 2023 Cash and cash equivalents $ 21,917 $ 17,313 Working capital 18,222 13,881 Total assets 109,400 106,008 Accumulated deficit (304,572) (288,517) Total stockholders' equity $ 56,016 $ 6,887 Aileron Therapeutics, Inc. Condensed Consolidated Statement of Operations (Unaudited) (In thousands, except share and per share data) Three Months Ended June 30, 2024 2023 Revenue $ - $ - Operating expenses: Research and development 3,741 187 General and administrative 5,298 1,893 Restructuring and other costs - (88) Total operating expenses 9,039 1,992 Loss from operations (9,039) (1,992) Other income (expense), net 97 205 Net loss (8,942) (1,787) Net loss per share — basic and diluted $ (0.
45) $ (0.39) Weighted average common shares outstanding—basic and diluted 19,911,462 4,541,167 View original content to download multimedia: https://www.prnewswire.
com/news-releases/aileron-therapeutics-reports-second-quarter-2024-financial-results-and-business-highlights-302222882.html SOURCE Aileron Therapeutics, Inc..
