ADDED
As of March 24, 2026 t he Registrant has 28,039,032 shares of Common Stock, $0.001 par value per share, outstanding.
These risks are discussed more fully in the Risk Factors section of this Annual Report.
We will require substantial additional capital to finance our operations beyond the second quarter of 2026 and to complete the development and commercialization of our product candidates.
Due to our current liquidity constraints, we have paused development of LTI 01 and other preclinical programs for an undetermined period and are prioritizing LTI 03.
If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay our clinical and research and development program, future commercialization efforts or other operations.
Risks Related to the Discovery, Development and Commercialization of Product Candidates Our business is highly dependent on the success of our product candidate, LTI-03, which is now screening and recruiting patients in a Phase 2 clinical trial that initiated in May 2025.
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of LTI-03.
We currently have two product candidates in clinical development, LTI-03 and LTI-01, however, due to insufficient funding we have paused development of LTI 01 for an undetermined period of time and are prioritizing LTI 03.
In the fourth quarter of 2025, we decided to pause development activities related to LTI-01 and preclinical programs targeting cystic fibrosis and a peptide program focused on the Cav1 protein for an indefinite period.
Three approved drugs, Nerandomilast (Jascayd ), nintedanib (OFEV ) and pirfenidone, have been shown to reduce the rate of lung function decline, but unfortunately provide only modest clinical benefit in IPF patients.
REMOVED
Suite 250 #390 Austin , TX 78758 (Address of principal executive offices) (Zip Code) Registrant s telephone number, including area code : ( 737 ) 802-1989 Aileron Therapeutics, Inc.
As of March 27, 2025 t he Registrant has 21,992,387 shares of Common Stock, $0.001 par value per share, outstanding.
These risks are discussed more fully in the Risk Factors section of this Annual Report on Form 10-K for the year ended December 31, 2024.
These risks include the following: Risks Related to Our Financial Condition We believe that our existing cash and cash equivalents will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into August 2025, as a result we will need to obtain sufficient additional funding prior to initiating our planned Phase 2 clinical trial of LTI-03.
We will require substantial additional capital to finance our operations beyond August 2025 and to complete the development and commercialization of LTI-03 and LTI-01.
If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our clinical and research and development programs, future commercialization efforts or other operations.
Our cash and cash equivalents are not sufficient to fund operations for at least the next twelve months from the date of issuance of the consolidated financial statements included elsewhere in this Annual Report, which raises substantial doubt about our ability to continue as a going concern.
Risks Related to the Discovery, Development and Commercialization of Product Candidates Our business is highly dependent on the success of our product candidates, LTI-03 and LTI-01 and any other product candidates that we advance into clinical development.
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of LTI-03, LTI-01 or any other product candidates.
We have entered into a collaboration agreement with Taiho Pharmaceutical Co., Ltd., or Taiho, for the development of LTI-01 in Japan and may in the future seek to enter into collaborations with third parties for the development and commercialization of other product candidates.