Aileron Therapeutics Announces Rebranding to Rein Therapeutics

Rhea-AI Summary

Aileron Therapeutics announced its rebranding to Rein Therapeutics, reflecting its focus on developing therapies for orphan pulmonary and fibrosis indications. The company's stock will trade under the new symbol RNTX starting January 13, 2025.

The company reported positive topline data from Cohort 2 of its Phase 1b trial for LTI-03 in November 2024, showing statistical significance in four biomarkers and dose dependence in five markers for idiopathic pulmonary fibrosis (IPF) treatment. The high-dose LTI-03 (5 mg BID) demonstrated a favorable safety profile.

In 2024, Brian Windsor was appointed CEO, and the company raised $17.7 million through a stock offering. For 2025, Rein plans to initiate a Phase 2 trial for LTI-03 in IPF treatment. The company also has LTI-01, a Phase 2b-ready asset for loculated pleural effusions, which has received Orphan Drug and Fast Track Designations.

Positive

• Positive Phase 1b trial results for LTI-03 with statistical significance in multiple biomarkers
• Successful fundraising of $17.7 million through stock offering
• Two Phase 2-ready clinical assets in pipeline
• Fast Track and Orphan Drug Designations for LTI-01

Negative

• Dilution of shareholder value through common stock offering

Insights

Biotech Research Analyst

The rebranding from Aileron to Rein Therapeutics represents more than a superficial change - it marks a strategic pivot focusing exclusively on fibrosis and pulmonary indications, anchored by two Phase 2-ready assets. The positive Phase 1b data for LTI-03 showing statistical significance across four biomarkers and dose-dependent responses in five markers demonstrates promising early efficacy signals. The 17.7 million capital raise provides runway for advancing both clinical programs.

LTI-03's mechanism targeting Caveolin-1 is particularly intriguing for IPF treatment, as this protein plays a important role in fibroblast regulation. The planned Phase 2 trial could potentially validate this novel approach. Meanwhile, LTI-01's dual regulatory designations (Orphan Drug and Fast Track) for pleural effusions treatment provides accelerated development pathways and market exclusivity benefits.

For a 41.8 million market cap company, having two Phase 2-ready assets with novel mechanisms and regulatory advantages represents substantial value potential, especially in the high-unmet need areas of fibrosis and pulmonary diseases where acquisition interest from larger pharma companies remains strong.

Corporate Strategy Expert

The rebranding aligns with a focused business strategy targeting specific high-value therapeutic areas. The appointment of Brian Windsor as CEO in March 2024 and subsequent successful fundraising indicates strong execution of this strategic shift. The company has effectively streamlined its pipeline to focus on two promising late-stage clinical candidates with clear development paths.

The timing of this rebranding is strategic, coinciding with the advancement of LTI-03 into Phase 2 trials. This creates a clear narrative for investors and potential partners, particularly important given the company's small market capitalization. The focus on orphan indications is noteworthy - this approach typically requires smaller clinical trials, lower development costs and can command premium pricing if approved.

The combination of regulatory advantages (Orphan Drug and Fast Track designations), novel mechanisms of action and focus on underserved markets positions Rein Therapeutics favorably for potential partnerships or acquisition interest from larger pharmaceutical companies seeking to expand their rare disease portfolios.

Rebrand to Rein Therapeutics is representative of the Company's sole focus in developing therapies in orphan pulmonary and fibrosis indications, including two Phase 2-ready clinical assets

Company shares to begin trading on Nasdaq under the trading symbol "RNTX" effective January 13, 2025

AUSTIN, Texas, Jan. 10, 2025 /PRNewswire/ -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), formerly known as 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 announced that it has changed its name to Rein Therapeutics, Inc. The new name, logo, website, and branding elements reflect the Company's mission to develop first-in-class treatments to rein in diseases. The Company's common stock will begin trading under the Nasdaq ticker symbol "RNTX" effective January 13, 2025. The CUSIP number for the Company's common stock is not affected by the name change. The Company also highlighted its recent clinical and corporate achievements and provided its key strategic objectives for 2025.

"Our rebrand to Rein Therapeutics reflects our unwavering commitment to address the critical needs of underserved patients with fibrotic diseases," said Brian Windsor, Ph.D., President and Chief Executive Officer. "This new chapter for the Company underscores our focus on reining in fibrosis and advancing our pipeline of novel candidates. We look forward to the initiation of a Phase 2 clinical trial for our lead candidate, LTI-03, in the first half of this year, aiming to bring hope to those affected by idiopathic pulmonary fibrosis."

Recent Clinical Achievements

• LTI-03, a Caveolin-1 related peptide:
  • In November 2024, the Company announced positive topline data from Cohort 2 of the Phase 1b clinical trial evaluating the safety and tolerability of inhaled high dose LTI-03 (5 mg BID) and a set of exploratory biomarkers in patients with idiopathic pulmonary fibrosis (IPF). Four biomarkers showed statistical significance in the combined Cohort 1 and Cohort 2 dataset, and five demonstrated dose dependence with respect to low dose (2.5 mg BID) Cohort 1, indicative of active pharmacodynamics. High dose LTI-03 continued to exhibit a favorable safety profile.

• 2024 Corporate Highlights:
  • In March 2024, Brian Windsor, Ph.D., was appointed Chief Executive Officer of the Company, marking the Company's sole focus on advancing a pipeline of first-in-class therapies for orphan pulmonary and fibrosis indications.
    
    
  • In May 2024, the Company completed an underwritten registered direct offering of its common stock and accompanying warrants raising net proceeds of approximately $17.7 million.

2025 Strategic Objectives and Anticipated Milestones

• LTI-03: A Phase 2 trial of LTI-03 for the treatment of IPF is anticipated to be initiated in the first half of this year.
  
  
• LTI-01: The Company's Phase 2b-ready asset is a first-in-class therapy for the treatment of loculated pleural effusions (LPEs). It holds Orphan Drug Designation for the treatment of pleural empyema in the U.S and E.U. and Fast Track Designation in the U.S.

About Rein Therapeutics

Rein Therapeutics is a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Rein'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. A Phase 2 clinical trial of LTI-03 for the treatment of idiopathic pulmonary fibrosis is anticipated to be initiated in the first half of this year. Rein'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 U.S. and E.U. and Fast Track Designation in the U.S. For more information, please visit the company's website at reintx.com, or follow them on LinkedIn and X.

Forward-Looking Statements

This press release may contain forward-looking statements of Rein Therapeutics, Inc. ("Rein", 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; and future expectations, plans and prospects for the Company. 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.

Rein Investor Relations & Media Contact
Argot Partners
rein@argotpartners.com
212-600-1902

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SOURCE Rein Therapeutics, Inc.

FAQ

When will Aileron Therapeutics (ALRN) change its ticker to RNTX?

Aileron Therapeutics will begin trading under the new ticker symbol RNTX on January 13, 2025, following its rebranding to Rein Therapeutics.

What were the Phase 1b trial results for Rein Therapeutics' LTI-03 in IPF treatment?

In November 2024, the Phase 1b trial showed positive results with four biomarkers demonstrating statistical significance and five showing dose dependence, along with a favorable safety profile for high-dose LTI-03.

How much capital did Rein Therapeutics (ALRN) raise in its 2024 stock offering?

The company raised approximately $17.7 million in net proceeds through an underwritten registered direct offering of common stock and accompanying warrants in May 2024.

What are the key clinical assets in Rein Therapeutics' pipeline?

Rein Therapeutics has two Phase 2-ready assets: LTI-03 for idiopathic pulmonary fibrosis and LTI-01 for loculated pleural effusions.