| Item 5.03 |
Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year. |
On July 10, 2025, the Board of Directors (the “Board”) of Rein Therapeutics, Inc. (the “Company”) approved an amendment to the Company’s Amended and Restated By-laws (as amended, the “By-laws”), effective immediately, to provide that forty percent (40%) of the shares of capital stock of the Company issued and outstanding and entitled to vote at the meeting, present in person, present by means of remote communication in a manner, if any, authorized by the Board in its sole discretion, or represented by proxy shall constitute a quorum at all meetings of the stockholders for the transaction of business except as otherwise provided by law, the Restated Certificate of Incorporation, as amended, or the By-laws.
A copy of the amendment to the By-laws is attached as Exhibit 3.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the amendment to the By-laws is qualified in its entirety by reference to such exhibit.
On June 10, 2025, the Company announced that the Company’s product candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF), LTI-03, had been put on clinical hold by the United States Food and Drug Administration (the “FDA”). Both enrollment and dosing in the Company’s Phase 2 RENEW trial of LTI-03 had been paused.
The Company received a formal Clinical Hold Letter from the FDA on July 8, 2025 (the “Letter”). In the Letter, the FDA noted that no No-Observed-Adverse-Effect Level (NOAEL) had been identified and minimal mucus cell hyperplasia in the bronchioles had been observed in the 26-week rat study conducted in support of the RENEW trial. The FDA stated that without a NOAEL, there is inadequate nonclinical support for the Phase 2 RENEW trial.
The FDA requested that the Company conduct a rat inhalation toxicity study using doses low enough to identify a NOAEL with a dosing duration sufficient to support the Phase 2 RENEW trial.
The Company believes that the data from the 26-week rat study supports the safety profile of LTI-03 and the conduct of the Phase 2 RENEW trial. The Company intends to work with the FDA to address the clinical hold as expeditiously as possible.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K may contain forward-looking statements of the Company within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to future expectations, plans and prospects for the Company. The Company uses 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 of the Company to obtain the cash resources to fund the RENEW Phase 2 trial through its completion and the Company’s operations for the anticipated periods and the Company’s ability to manage unplanned cash requirements; uncertainty as to when the clinical hold may be resolved, including the actions or studies that the Company may be required to take or conduct in order to resolve the clinical hold, and the implications of delays in the RENEW Phase 2 trial with respect to the Company’s cash resources; 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 the RENEW Phase 2 trial, 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; the Company’s ability to successfully
