LTI-03 / Rein Therapeutics - LARVOL DELTA

Late Breaking Abstract - Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study (ERS 2026) - P1, P2 | "Inhaled LTI-03 demonstrated a favourable safety profile together with biomarker evidence of target engagement and antifibrotic activity in IPF patients. These first-in-human results support advancement to Phase 2 evaluation (RENEW trial; NCT06968845)."

Clinical • First-in-human • Late-breaking abstract • Cough • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • TSLP

Rein Therapeutics to Present Late-Breaking Poster at the European Respiratory Society (ERS) 2026 Congress (GlobeNewswire)

Late-breaking abstract • P1 data • Idiopathic Pulmonary Fibrosis

Rein Therapeutics Receives U.S. FDA Fast Track Designation for LTI-03 in Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "Designation reflects serious unmet need in idiopathic pulmonary fibrosis (IPF), where approved therapies slow but do not halt disease progression."

Fast track • Idiopathic Pulmonary Fibrosis

Rein Therapeutics Announces Publication of Landmark LTI-03 Clinical Data in Nature Communications (GlobeNewswire) - "The randomized, placebo-controlled study enrolled 24 IPF patients who received inhaled LTI-03 at 5 or 10 mg/day, or placebo, for 14 days. LTI-03 was well-tolerated at both doses, with no treatment-related discontinuations and only mild or moderate side effects.....At the higher dose, LTI-03 additionally reduced a direct marker of collagen deposition, the primary component of scar tissue (COL1A1); an inflammatory chemokine elevated in IPF lungs (CXCL7); and a protein associated with epithelial fibrosis deep in the lung (galectin-7). A trend toward reduced levels of surfactant protein D (SP-D), a blood marker of lung epithelial cell health, was also observed at the higher dose..."

First-in-human • P1 data • Idiopathic Pulmonary Fibrosis

Actively enrolling patients in the global Phase 2 RENEW trial evaluating LTI-03 in patients with IPF. (GlobeNewswire) - "As of August, Rein has surpassed 25% of the trial’s planned enrollment of approximately 120 patients across the United States, United Kingdom, Australia, Germany and Poland. Enrollment is tracking ahead of schedule and the Company remains on track to report interim data in the second half of 2026."

Enrollment status • P2 data • Idiopathic Pulmonary Fibrosis

Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study. (PubMed, Nat Commun) - P1 | "The favorable safety profile and reductions in disease-related biomarkers support further evaluation of inhaled LTI-03 for IPF. This study was fully funded by Rein Therapeutics, Inc."

Biomarker • Clinical • Journal • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • TSLP

Rein Therapeutics, Inc…announced that its Phase 2 RENEW clinical trial is now open and enrolling patients across all five planned countries, with Germany joining the United States, United Kingdom, Australia, and Poland. (GlobeNewswire) - "Company on track to report initial topline data in 2H 2026."

P2 data • Trial status • Idiopathic Pulmonary Fibrosis

Rein Therapeutics Expands Phase 2 RENEW Trial into United Kingdom (The Manila Times) - "The Company announced that the first patient has been randomized in the United Kingdom, marking another milestone in the ongoing expansion of the Phase 2 RENEW clinical trial. Rein has now enrolled 16 patients in the trial to date...Clinical trial sites are currently enrolling patients in the United States, Australia, and the United Kingdom. Additional sites in two more countries are expected to begin enrollment in the coming months as the Company continues to expand its global clinical trial footprint....The study is expected to enroll approximately 120 patients, who will be randomized to receive one of two dose levels of LTI-03 or placebo."

Trial status • Idiopathic Pulmonary Fibrosis

Rein Therapeutics closes $57.5 million stock offering (Investing.com) - "The company plans to use net proceeds to fund its ongoing Phase 2 clinical trial of LTI-03 in idiopathic pulmonary fibrosis through completion, support clinical development, manufacturing and regulatory activities, and fund working capital and general corporate purposes."

Financing • Idiopathic Pulmonary Fibrosis

Rein Therapeutics Provides Clinical Trial Update for Phase 2 RENEW Study of LTI-03 in Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "The Company has enrolled 8 patients in its RENEW trial to date, with 2 additional patients expected to be enrolled this week. Enrollment in the study began in March 2026, and the Company continues to add patients on a regular basis....Clinical trial sites are currently active in the United States, Australia, and Poland, with additional countries – including the United Kingdom and Germany – expected to open in the near term. The Company plans to continue activating more new sites to support ongoing enrollment."

Trial status • Idiopathic Pulmonary Fibrosis

A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Rein Therapeutics

Trial initiation date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Rein Therapeutics Doses First Patient in Phase 2 Trial of LTI-03 for Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "The Phase 2 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and impact to lung function and structure of LTI-03, an inhaled therapy intended to regulate multiple fibrosis pathways and preserve lung function. The study will enroll approximately 120 patients across placebo, low dose, and high dose groups at clinical sites in five countries....Rein expects to enroll patients through mid-2027, with interim data anticipated in the second half of 2026."

P2 data • Trial status • Idiopathic Pulmonary Fibrosis

LTI-03-2001 (RENEW): RENEW - A Phase 2 Study of the Safety, Tolerability and Efficacy of LTI-03 in Patients with Idiopathic Pulmonary Fibrosis (clinicaltrialsregister.eu) - P1/2 | N=28 | Not yet recruiting | Sponsor: Rein Therapeutics Inc.

New P1/2 trial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Rein Therapeutics | Trial completion date: May 2027 ➔ Dec 2027 | Initiation date: May 2025 ➔ Feb 2026 | Trial primary completion date: May 2027 ➔ Sep 2027 | Active, not recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Rein Therapeutics Receives Orphan Drug Designation from European Medicines Agency for Lead Drug Candidate in Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "The designation follows a positive opinion from the EMA’s Committee for Orphan Medicinal Products (COMP) and subsequent adoption by the European Commission....The EMA’s final decision was supported by preclinical data demonstrating improved survival and lung function, reinforcing the scientific rationale behind Rein’s approach to targeting fibrosis. The EMA also agreed with Rein’s justification that LTI-03 could be of significant benefit to those affected by the condition as compared to authorized products..."

Orphan drug • Idiopathic Pulmonary Fibrosis

Inhaled LTI-03 for Idiopathic Pulmonary Fibrosis: A Randomized Dose Escalation Study. (PubMed, medRxiv) - "Any queries regarding clinical study data must be submitted in writing to https://[email protected] . A data supplement for this article is available via the Supplements tab at the top of the online article."

Journal • Cough • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CAV1 • TSLP

Rein Therapeutics Announces New Scientific Publication Demonstrating LTI-03 May Reduce Lung Scarring and Protect Cells Needed for Lung Repair in IPF (GlobeNewswire) - "According to the authors, LTI-03 was generally well tolerated, and samples collected from treated patients showed reductions in multiple fibrosis-associated biomarkers. These biomarkers include proteins and inflammatory signals linked to disease progression, offering evidence that the drug is reaching the lung and engaging its intended targets. The investigators also reported that LTI-03 helped preserve alveolar epithelial type II (AT2) progenitor cells, which are essential for lung repair and regeneration."

Clinical data • Idiopathic Pulmonary Fibrosis

Rein Therapeutics…announced that the U.S. Food and Drug Administration (FDA) has lifted the full clinical hold on the Company’s Phase 2 'RENEW' trial evaluating LTI-03 in patients with idiopathic pulmonary fibrosis (IPF) (GlobeNewswire) - "FDA lifts clinical hold following review of Company’s Complete Response submission. Company expects to restart U.S. enrollment in late 2025 or early 2026 across 20 clinical sites....Initial topline data is expected in Q3 2026."

Enrollment status • FDA event • P2 data • Idiopathic Pulmonary Fibrosis

Rein Therapeutics Receives European Regulatory Approval to Initiate Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "The approvals cover clinical trial sites in Germany and Poland, which will serve as key European centers for the global study.....The study will enroll up to 120 patients globally, with a treatment duration of 24 weeks across two dosing groups."

Trial status • Idiopathic Pulmonary Fibrosis

LTI-03 peptide demonstrates anti-fibrotic activity in ex vivo lung slices from patients with IPF. (PubMed, iScience) - "Modulation was comparable to nintedanib but without the induction of apoptosis or necrosis pathways. These results demonstrate LTI-03's potential therapeutic efficacy in a highly relevant translational disease model and support LTI-03 as a promising next-generation therapeutic to halt IPF progression and improve patient outcomes."

Journal • Preclinical • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CAV1 • PTEN

Peer-reviewed publication highlights potential breakthrough anti-fibrotic properties of LTI-03 in lung tissue from IPF patients (GlobeNewswire) - "LTI-03 reduced multiple scarring pathways (including TGFβ, VEGF, PDGF, and FGF), while also lowering collagen production and inflammatory signals in diseased lung tissue. Unlike nintedanib, the FDA-approved standard-of-care drug, LTI-03 achieved these effects without causing cell damage or death in patient samples, reinforcing the drug’s strong safety profile."

Preclinical • Idiopathic Pulmonary Fibrosis

Rein Therapeutics Wins U.K. Approval to Launch Phase 2 Clinical Trial of LTI-03 in Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "The RENEW trial is expected to enroll up to 120 patients worldwide, evaluating two dose groups of LTI-03 against a placebo. The primary objective of the trial is to assess safety and tolerability over 24 weeks of treatment. Secondary endpoints will include measures of lung function and imaging-based assessments of fibrosis progression....Rein is actively working with clinical sites in the UK to begin patient recruitment soon, with initial data expected in 2026."

P2 data • Trial status • Idiopathic Pulmonary Fibrosis

Rein Therapeutics to Present Novel IPF Science and Clinical Development Insights at IPF Summit 2025 (GlobeNewswire) - "Dr. Hogaboam will...The role of key immune cells in idiopathic pulmonary fibrosis (IPF) called lung-resident macrophages; How macrophage modulation may be critical to stopping the disease from getting worse; How Caveolin-scaffolding domain (CSD) peptides, the class of molecules Rein is advancing, target multiple drivers of fibrosis and could potentially help repair lung tissue...Dr. Windsor’s....will provide: An overview of Rein’s Phase 2 trial of LTI-03, which will enroll up to 120 patients, assess safety and tolerability, and focus on lung function as a key outcome; A discussion of trial design, strategies around patient recruitment, and how Rein is working to make the study feasible and relevant in a fast-changing treatment landscape."

Clinical • Trial status • Idiopathic Pulmonary Fibrosis

Rein Therapeutics Enters into Agreements for up to $21 Million in Flexible Financing (GlobeNewswire) - "Rein Therapeutics...announced that it has entered into two strategic financing agreements with an affiliate of Yorkville Advisors Global, LP, providing the potential for access to up to $21 million in capital. The financing includes: A $6 million pre-paid advance agreement, with an initial $1 million advance funded at signing. A $15 million standby equity purchase agreement (SEPA), which Rein may use at its discretion over 36 months, subject to an effective registration statement. Rein intends to use the proceeds from these facilities to support its RENEW Phase 2 trial of its lead asset – LTI-03 – for the treatment of idiopathic pulmonary fibrosis (IPF), for the research and development of other product candidates, and for working capital and other general corporate purposes."

Financing • Idiopathic Pulmonary Fibrosis

A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Rein Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases