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Aileron Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Topline results from Phase 1b study of LTI-03, a novel Caveolin-1-related peptide in development for the treat

Key Takeaway: Aileron Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Topline results from Phase 1b study of LTI-03, a novel Caveolin-1-related peptide in development for the treatment of idiopathic pulmonary fibrosis, expected to be reported in

Full Press Release Details

Aileron Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business
Topline results from Phase 1b study of LTI-03, a novel Caveolin-1-related peptide in development for the treatment of idiopathic pulmonary fibrosis, expected to be reported in the third quarter of 2024
Cash runway expected to fund operations and key milestones into the fourth quarter of 2024
AUSTIN, Texas, April 15, 2024 (GLOBE NEWSWIRE) 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, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.
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
Fourth Quarter and Full Year 2023 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. 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 of the Phase 1b study of LTI-03; future expectations, plans and prospects for the Company following the merger transaction between
the Company and Lung that closed in the fourth quarter of 2023 (the Merger ); 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 the ability to recognize the anticipated benefits of the Merger; 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; 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; our ability to obtain, maintain and enforce intellectual property rights for our platform and development candidates; our
potential dependence on collaboration partners; competition; uncertainties as to 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, which is on file with the United States Securities and Exchange Commission and in subsequent filings that the Company files with the Securities and Exchange Commission. 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.
December 31, 2023 December 31, 2022
Cash, cash equivalents and investments $ 17,313 $ 21,242
Working capital 13,881 18,489
Total assets 106,008 22,007
Accumulated deficit (288,517 ) (272,785 )
Total stockholders equity 6,887 18,623
Aileron Therapeutics, Inc.
Condensed Statement of Operations
(In thousands, except
share and per share data)
Three Months Ended December 31, Year Ended December 31,
2023 2022 2023 2022
Revenue $ $ $ $
Operating expenses:
Research and development 1,972 2,402 3,991 17,967
General and administrative 5,330 2,301 11,357 9,680
Restructuring and other (12 ) 928
Total Operating expenses 7,290 4,703 16,276 27,647
Loss from operations (7,290 ) (4,703 ) (16,276 ) (27,647 )
Other income (expense), net (49 ) 156 544 318
Net loss (7,339 ) (4,547 ) (15,732 ) (27,329 )
Net loss per share basic and diluted $ (1.54 ) $ (1.00 ) $ (3.42 ) $ (6.02 )
Weighted average common shares outstanding basic and diluted 4,769,483 4,541,167 4,598,715 4,539,318
Last updated: Apr 15, 2024