RNTX

Surpassed 25% enrollment milestone in the Global Phase 2 RENEW trial evaluating LTI-03 in idiopathic pulmonary fibrosis (IPF); on track to report interim data in the second half of 2026 Successfully completed oversubscribed $57.5 million public offering supported by both new and existing healthcare-focused investors AUSTIN, Texas, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines in orphan pulmonary and fibrosis indications, today reported financial results for the second quarter ended June 30, 2026 and provided a business update. “We ended the second quarter with momentum as we made significant progress in our Phase 2 RENEW trial evaluating LTI-03 in patients with IPF and simultaneously bolstered our balance sheet supporting our work through key clinical milestones,” said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. “With all clinical trial sites up and running, we are encouraged by the rapid pace of enrollment we are seeing as we work to efficiently generate high-quality clinical data supporting LTI-03. We believe LTI-03 has the potential to be a differentiated multi-pathway treatment for patients with IPF and deliver both anti-fibrotic and potentially regenerative effects alongside a favorable safety and tolerability profile. With a strengthened balance sheet and enrollment ongoing in the trial, we believe we are well positioned to achieve our near-term clinical milestones, including reporting interim data in the second half of this year.” Second Quarter 2026 and Recent Business Updates Clinical Updates Actively enrolling patients in the global Phase 2 RENEW trial evaluating LTI-03 in patients with IPF. LTI-03 is a novel synthetic peptide which inhibits multiple profibrotic proteins and protects key progenitor cells in the lungs. LTI-03 mimics the activity of Caveolin-1, a key regulator of proteins in multiple fibrosis-related pathways which address key drivers of disease progression in IPF. The RENEW study is a randomized, placebo-controlled Phase 2 trial evaluating inhaled LTI-03 in patients with IPF, with change from baseline in forced vital capacity (FVC) as the primary efficacy endpoint. Publications and Presentations Peer-reviewed publication validates first-in-human clinical study demonstrating clinically relevant reductions in key markers of lung scarring and inflammation in IPF patients. The publication titled "Inhaled LTI-03 for Idiopathic Pulmonary Fibrosis: A Randomized Dose Escalation Study” was published in Nature Communications (DOI: https://doi.org/10.1038/s41467-026-75291-3) on July 31, 2026. Results demonstrated that LTI-03 was well-tolerated and produced significant reductions in multiple markers of lung scarring. Corporate Updates Successfully completed oversubscribed $57.5 million underwritten public offering. The offering included full exercise of the underwriters' over-allotment option and was supported by new and existing healthcare-focused investors. The Company expects the proceeds to fully fund the Phase 2 RENEW trial of LTI-03 in IPF and support operations into the first quarter 2028. Second Quarter 2026 Financial Results Cash position: Cash, cash equivalents and marketable securities were $43.6 million as of June 30, 2026. The Company’s cash, cash equivalents and marketable securities as of June 30, 2026 are expected to fund its operations into the first quarter of 2028. R&D expenses: Research and development expenses were $3.6 million for the quarter ended June 30, 2026, compared to $4.3 million for the comparable prior year period. The decrease was primarily due to a reduction in direct research and development services costs of $0.7 million compared to the three months ended June 30, 2025. G&A expenses: General and administrative expenses were $2.4 million for the quarter ended June 30, 2026, compared to $2.6 million for the comparable prior year period. The decrease was primarily due to decreased employee related expenses as a result of a decrease in stock-based compensation expense, and decreased facilities and other expenses. Net loss: Net loss was $6.4 million for the quarter ended June 30, 2026, compared to $6.8 million for the comparable prior year period. 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. LTI-03 has received Orphan Drug Designation in the U.S. 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. Cautionary Note Regarding 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 expectations for the Company’s LTI-03 product candidate, the Phase 2 trial evaluating LTI-03 and the Company’s working capital requirements. 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: (i) the risk that the Company may not be able to successfully continue its Phase 2 clinical trials of LTI-03; (ii) the risk that the Company may not report data derived from its Phase 2 trial in the second half of 2026 or, if it does, the risk that the data may not support or validate our expectations concerning the potential benefits of LTI-03; (iii) success in early phases of pre-clinical and clinical trials do not ensure later clinical trials will be successful; (iv) the risk that the Company’s present cash and cash equivalents may not be sufficient to fund the Company’s operations into the first quarter of 2028 and (v) those other risks disclosed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 26, 2026, and in subsequent filings that the Company makes with the SEC. These forward-looking statements should not be relied upon as representing the Company’s views as of any date after the date of this press release, and the Company expressly disclaims 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 Therapeutics Investor Relations & Media Contact: Investor Relations [email protected]

RENEW Phase 2 trial evaluating the safety, tolerability, and efficacy of LTI-03 in idiopathic pulmonary fibrosis (IPF) initiated with topline interim data expected in the first half of 2026 Two abstracts accepted to the American Thoracic Society (ATS) 2025 International Conference Cash runway extended following previously announced warrant transactions and private placement AUSTIN, Texas, May 15, 2025 /PRNewswire/ -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), 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 first quarter ended March 31, 2025 and provided a business update. "Rein has completed a multitude of key accomplishments since the beginning of the year, and we are particularly excited to have initiated the Phase 2 RENEW trial of LTI-03 in patients with IPF," said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. "We have taken several strategic steps to prepare for this trial. Our LTI-03 program continues to evolve as we entered into a collaboration with Qureight to bring cutting-edge technology to our imaging and data analysis and obtained patents covering our novel formulation and administration methods. We are committed to continuing this momentum of execution and we look forward to advancing the RENEW trial and sharing topline interim data, which is expected in the first half of next year." Recent Clinical and Corporate Highlights and Upcoming Milestones Clinical Updates In May 2025, the Company initiated the RENEW Phase 2 trial of LTI-03 in idiopathic pulmonary fibrosis (IPF), with screening and recruitment of patients underway. The RENEW trial is a multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of LTI-03 in patients with IPF. The trial is designed to enroll approximately 120 patients randomized into two cohorts to receive either low dose (2.5 mg BID) or high dose (5 mg BID) of LTI-03 or placebo. Topline interim data from this trial is expected in the first half of 2026. In April 2025, Rein announced a collaboration with Qureight Ltd to integrate Qureight's deep-learning AI image analysis into the Phase 2 RENEW trial of LTI-03, to allow for a more detailed examination of LTI-03's potential ability to simultaneously modulate pro-fibrotic activity and to protect critical alveolar epithelial cells. Rein was granted two patents covering the novel formulation and administration methods of dry powder LTI-03 for the treatment of respiratory diseases. U.S. Patent No. 12,280,088 and U.S. Patent No. 12,280,089, both titled, "Dry Powder Formulation of Caveolin-1 Peptides and Methods of Use Thereof", were issued by the U.S. Patent and Trademark Office (USPTO) on April 22, 2025. In April 2025, Rein also announced a publication in the peer-reviewed journal, Biomedicines, highlighting the therapeutic potential of Caveolin-1-related peptide LTI-2355 in IPF and post-acute sequelae of COVID fibrosis (PASC-F). LTI-2355 was seen to improve the phagocytic, or anti-infective, activity of both IPF and PASC-F myeloid cells compared with control peptide-treated cells, which coincided with decreasing pro-inflammatory and pro-fibrotic synthetic activity of the diseased cells. The Company and its collaborators will present two posters at the upcoming American Thoracic Society (ATS) 2025 International Conference in May 2025. Poster details include: Presentation Title: Pre-clinical Proof-of-concept of Anti-fibrotic Activity of Caveolin-1 Scaffolding Domain Peptide LTI-03 in Ex Vivo Precision Cut Lung Slices from Patients with Idiopathic Pulmonary Fibrosis Poster #: P1422 Session: B74 Advanced Models and Molecular Signatures for Understanding and Treating Pulmonary Fibrosis Date & Time: Monday, May 19, 2025, at 11:30 AM PT/2:30 PM ET Presentation Title: Evaluating Alveolar Regenerative Properties of Caveolin Scaffolding Peptides (CSD) in Three Dimensional (3D) Alveolospheres from IPF and Normal Donor Lung Samples Poster #: P1463 Session: B75 Targeting Cellular Senescence, Immune Dysregulation, and Metabolism in Lung Injury and Fibrosis Date & Time: Monday, May 19, 2025, at 11:30 AM PT/2:30 PM ET Corporate Updates In January 2025, the Company rebranded to Rein Therapeutics, Inc. from Aileron Therapeutics, Inc., and the Company's common stock began trading under the Nasdaq ticker symbol "RNTX" on January 13, 2025. In April 2025, Rein completed warrant exercise and exchange transactions with certain holders of its outstanding warrants, as well as a simultaneous private placement with an entity affiliated with Bios Equity Partners, LP (together the "April 2025 Transactions"). The Company received aggregate gross proceeds of approximately $5.28 million from the April 2025 Transactions. First Quarter 2025 Financial Results Cash Position: Cash and cash equivalents as of March 31, 2025, were $7.4 million, compared to $12.9 million as of December 31, 2024. Based on the Company's current operating plan, the Company believes that its cash and cash equivalents as of March 31, 2025, together with the proceeds raised in the April 2025 Transactions, will enable the Company to fund its planned operating expense and capital expenditure requirements through September 2025. Research and Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2025, were $3.1 million, compared to $3.5 million for the quarter ended March 31, 2024. The decrease of $0.4 million was primarily due to the temporary delay of further clinical development of LTI-01. During the three months ended March 31, 2025, the Company spent $1.3 million on clinical trials, $0.9 million on manufacturing, $0.6 million on employee and related expenses, and $0.2 million on regulatory and development consulting. General and Administrative (G&A) Expenses: G&A expenses for the quarter ended March 31, 2025, were $2.5 million, compared to $3.7 million for the quarter ended March 31, 2024. The decrease of $1.2 million was primarily due to decreased professional fees of $0.9 million as a result of a decrease in legal expense, and decreased employee and related expenses of $0.3 million as a result of employee turnovers in 2024. Net Loss: Net loss for the quarter ended March 31, 2025, was $5.5 million, compared to $7.1 million for the quarter ended March 31, 2024. The basic and diluted net loss per share for the quarter ended March 31, 2025, was $0.25, compared to $0.86 for the quarter ended March 31, 2024. 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. LTI-03 has received Orphan Drug Designation in the U.S. A Phase 2 clinical trial of LTI-03 for the treatment of idiopathic pulmonary fibrosis was initiated in May 2025. 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 RENEW Phase 2 clinical trial of LTI-03, including with respect to the timing of the trial and the assumption that the Company will raise the funds necessary to conduct the trial; the sufficiency of the Company's cash resources for the period anticipated; 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: 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; 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 integrate Qureight's deep-learning platform into the RENEW Phase 2 trial; 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 our development candidates; 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, 2024, which is 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 after 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 [email protected] 212-600-1902 View original content to download multimedia:https://www.prnewswire.com/news-releases/rein-therapeutics-reports-first-quarter-2025-financial-results-and-provides-business-update-302457155.html SOURCE Rein Therapeutics, Inc.

Rein advanced the clinical development of its lead asset, LTI-03, and aims to initiate a Phase 2 trial for the treatment of idiopathic pulmonary fibrosis (IPF) in the first half of 2025 Positive topline results from Cohort 2 (5 mg BID) of the Phase 1b clinical trial of LTI-03 in IPF patients demonstrated dose dependent effects in five biomarkers evaluated, with four biomarkers achieving statistical significance in the combined Cohort 1 and Cohort 2 data set AUSTIN, Texas, April 7, 2025 /PRNewswire/ -- Rein Therapeutics, Inc. (NASDAQ: RNTX), 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, 2024 and provided a business update. "We've made significant clinical progress during 2024, culminating in promising safety and positive topline data from our Phase 1b trial of LTI-03 in IPF patients, which demonstrated early signs of therapeutic effect. LTI-03 has shown potential to improve lung function and potentially reverse the course of IPF, with its dual mechanism of action on both epithelial cells and fibroblasts gaining increasing support within the medical community," said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. "With our recent rebranding and renewed mission to combat fibrosis, we are excited to advance our pipeline. We are planning to initiate a Phase 2 study for LTI-03 in IPF in the first half of this year, where we will continue to evaluate the safety, tolerability and efficacy of this promising asset." Recent Clinical and Corporate Highlights and Upcoming Milestones Clinical Updates In November 2024, Rein announced positive topline data from Cohort 2 of the Phase 1b clinical trial evaluating the safety and tolerability of high dose LTI-03 (5 mg BID) and a set of exploratory biomarkers in patients diagnosed with IPF. Four biomarkers showed statistical significance in the combined Cohort 1 and Cohort 2 data set, and five demonstrated dose dependence, indicative of active pharmacodynamics. High dose LTI-03 continued to exhibit a favorable safety profile. A Phase 2 trial of LTI-03 for the treatment of IPF is anticipated to be initiated in the first half of this year, subject to funding. In October 2024, at the 22nd International Colloquium on Lung and Airway Fibrosis (ICLAF), Rein presented two abstracts highlighting preclinical and Phase 1b data for low dose LTI-03 (2.5 mg BID), reinforcing the potential of LTI-03 to improve lung function and reverse the course of IPF. Following inhaled administration of low dose LTI-03 in 12 patients over the course of 14 days, a positive trend was observed in biomarkers with evidence of reduced expression among multiple profibrotic proteins produced by basal-like cells and fibroblasts that contribute to the progression of IPF, including data from three biomarkers (collagen synthesis, inflammation, and fibrogenesis) that were statistically significant. Pre-clinical data further supported the potential therapeutic effectiveness of LTI-03 for IPF through precision cut lung slices (PCLS) performed ex-vivo. The studies demonstrated molecular activity in IPF PCLS explants indicative of fibrosis during five days in culture and LTI-03 broadly attenuated profibrotic proteins and pathways. Also in October 2024, the Company announced entry into an exclusive option agreement with Advancium Health Network for the acquisition of ALRN-6924, a clinical-stage oncology agent for retinoblastoma developed by the Company prior to its 2023 merger with Lung Therapeutics, Inc. Under the terms of the agreement, Rein received an upfront payment from Advancium for the exclusive option to acquire ALRN-6924 and related assets and could receive additional payments for development, regulatory and commercial milestones as well as sales royalties. Corporate Updates In January 2025, the Company rebranded to Rein Therapeutics, Inc. from Aileron Therapeutics, Inc. The new name, logo, website, and branding elements strategically aligns with the Company's sole focus to develop therapies in orphan pulmonary and fibrosis indications, including two Phase 2-ready clinical assets. The Company's common stock began trading under the Nasdaq ticker symbol "RNTX" effective January 13, 2025. Fourth Quarter and Full Year 2024 Financial Results Cash Position: Cash, cash equivalents, and investments on December 31, 2024, were $12.9 million, compared to $17.3 million on December 31, 2023. Research and Development (R&D) Expenses: R&D expenses for the quarter ended December 31, 2024, were $3.3 million, compared to $2.0 million for the quarter ended December 31, 2023. R&D expenses for the full-year 2024 were $14.2 million, compared to $4.0 million for the prior year. The increase in full year R&D expenses was primarily due to the termination of ALRN-6924 in 2023 and additional clinical programs acquired as part of the 2023 merger with Lung Therapeutics, Inc. General and Administrative (G&A) Expenses: G&A expenses for the quarter ended December 31, 2024, were $2.5 million compared to $5.3 million for the quarter ended December 31, 2023. G&A expenses for the full-year 2024 were $13.9 million, compared to $11.4 million for the prior year. The increase in full year G&A expenses was primarily due to increased headcount associated with the 2023 merger of Lung Therapeutics, Inc. and severance expense following the merger closure and increased facilities and other expenses as a result of the merger, offset by a decrease in professional fees. Net Loss: Net loss for the quarter ended December 31, 2024 was $41.0 million, compared to $7.3 million for the quarter ended December 31, 2023. The basic and diluted net loss per share for the quarter ended December 31, 2024, was $1.89 compared to a net loss per share of $1.54 for the quarter ended December 31, 2023. The increase in net loss in 2024 is mainly due to a non-cash impairment charge of $37.0 million related to aligning the carrying value of LTI-01 to the fair value. Excluding the non-cash charge, net loss per share for the fourth quarter ended December 31, 2024, was a loss of $0.26. The basic and diluted net loss per share for the full-year 2024 was $3.51, or an adjusted net loss per share of $1.53 excluding the non-cash impairment charge, compared to a net loss per share of $3.42 for the full-year 2023. 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. 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 clinical 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 its development candidates; the Company's ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; competition; the Company's ability to obtain additional funding and the sufficiency of the Company's cash resources, after financing, 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, 2024, which is 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 [email protected] 212-600-1902 View original content to download multimedia:https://www.prnewswire.com/news-releases/rein-therapeutics-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-business-update-302422429.html SOURCE Rein Therapeutics, Inc.