Rein Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update

PR Newswire

AUSTIN, Texas, May 15, 2025

RENEW Phase 2 trial evaluating the safety, tolerability, and efficacy of LTI-03 in idiopathic pulmonary fibrosis $(IPF.UK)$ 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") $(RNTX)$, 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 $(ATS.AU)$ 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

rein@argotpartners.com

212-600-1902

 
                         REIN THERAPEUTICS, INC. 
                   CONDENSED CONSOLIDATED BALANCE SHEETS 
              (In thousands, except share and per share data) 
 
                                 March 31,              December 31, 
                                    2025                     2024 
                           ----------------------  ----------------------- 
Assets 
Current assets: 
Cash and cash equivalents  $                7,428    $              12,865 
Prepaid expenses and 
 other current assets                         903                      792 
 Total current assets                       8,331                   13,657 
Property and equipment, 
 net                                            1                        1 
Goodwill                                    6,330                    6,330 
Intangible assets                          42,200                   42,200 
Other non-current assets                      766                        2 
 Total assets               $              57,628    $              62,190 
                           ======================  ======================= 
Liabilities, Convertible 
Preferred Stock and 
Stockholders' Equity 
Current liabilities: 
Accounts payable           $                1,149  $                   911 
Accrued expenses and 
 other current 
 liabilities                                4,828                    4,838 
                           ----------------------  ----------------------- 
 Total current 
  liabilities                               5,977                    5,749 
Deferred tax liability                      1,772                    1,772 
Other long-term liability                      --                      277 
 Total liabilities                          7,749                    7,798 
                           ----------------------  ----------------------- 
Commitments and 
contingencies (Note 13) 
Convertible preferred 
 stock, $0.001 par value, 
 5,000,000 shares 
 authorized at March 31, 
 2025 and at December 31, 
 2024; 24,610 shares 
 issued and 12,232 shares 
 outstanding at March 31, 
 2025 and at December 31, 
 2024                                      45,005                   45,005 
Stockholders' equity: 
Common stock, $0.001 par 
 value; 100,000,000 
 shares authorized at 
 March 31, 2025 and at 
 December 31, 2024; 
 22,005,317 shares and 
 21,666,012 shares issued 
 and outstanding at March 
 31, 2025 and December 
 31, 2024, respectively                       108                      108 
Additional paid-in 
 capital                                  361,699                  360,697 
Accumulated other 
 comprehensive loss                          (32)                     (18) 
Accumulated deficit                     (356,901)                (351,400) 
 Total liabilities, 
  convertible preferred 
  stock and stockholders' 
  equity                    $              57,628    $              62,190 
                           ======================  ======================= 
 
 
                         REIN THERAPEUTICS, INC. 
  CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS 
              (In thousands, except share and per share data) 
 
                                   Three Months Ended March 31, 
                        -------------------------------------------------- 
                                  2025                      2024 
Revenue                 $                     --  $                     -- 
                        ------------------------  ------------------------ 
Operating expenses: 
Research and 
 development                               3,054                     3,463 
General and 
 administrative                            2,555                     3,742 
 Total operating 
  expenses                                 5,609                     7,205 
                        ------------------------  ------------------------ 
Loss from operations                     (5,609)                   (7,205) 
Other income, net                            108                        92 
Net loss                  $              (5,501)    $              (7,113) 
                        ========================  ======================== 
Net loss per 
 share--basic and 
 diluted                 $                (0.25)   $                (0.86) 
                        ========================  ======================== 
Weighted average 
 common shares 
 outstanding--basic 
 and diluted                          21,915,891                 8,301,798 
                        ========================  ======================== 
Comprehensive loss: 
Net loss                  $              (5,501)    $              (7,113) 
Other comprehensive 
gain: 
Unrealized gain on 
investments, net of 
tax of $0                                   (45)                        -- 
                        ------------------------  ------------------------ 
Foreign currency 
translation 
adjustments                                   31                        -- 
                        ------------------------  ------------------------ 
 Total other 
 comprehensive gain                         (14)                        -- 
                        ------------------------  ------------------------ 
Total comprehensive 
 loss                     $              (5,515)    $              (7,113) 
                        ========================  ======================== 
 
 
                            REIN THERAPEUTICS, INC. 
                 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 
                                 (In thousands) 
 
                                  Three Months Ended March 31, 
                ---------------------------------------------------------------- 
                              2025                             2024 
                --------------------------------  ------------------------------ 
Cash flows 
from 
operating 
activities: 
Net loss          $                      (5,501)  $                      (7,113) 
Adjustments 
to reconcile 
net loss to 
net cash used 
in operating 
activities: 
Depreciation 
 and 
 amortization 
 expense                                      --                              59 
Stock-based 
 compensation 
 expense                                     264                             150 
Changes in 
operating 
assets and 
liabilities: 
 Prepaid 
  expenses and 
  other 
  current 
  assets                                   (125)                             185 
 Other assets                              (764)                           1,301 
 Accounts 
  payable                                    238                             966 
 Operating 
  lease 
  liabilities                                 --                            (48) 
 Accrued 
  expenses and 
  other 
  current 
  liabilities                               (10)                           (771) 
 Other 
 long-term 
 liabilities                               (277)                              -- 
Net cash used 
 in operating 
 activities                              (6,175)                         (5,271) 
                --------------------------------  ------------------------------ 
Cash flows 
from 
financing 
activities: 
Proceeds from 
issuance of 
common stock, 
net of 
offering 
costs                                        737                              -- 
Proceeds from 
issuance of 
common stock 
in connection 
with stock 
option 
exercises                                      1                              -- 
Net cash 
provided by 
financing 
activities                                   738                              -- 
                --------------------------------  ------------------------------ 
Net decrease 
 in cash, cash 
 equivalents 
 and 
 restricted 
 cash                                    (5,437)                         (5,271) 
Cash, cash 
 equivalents 
 and 
 restricted 
 cash at 
 beginning of 
 period                                   12,865                          17,338 
Cash, cash 
 equivalents 
 and 
 restricted 
 cash at end 
 of period        $                        7,428   $                      12,067 
                ================================  ============================== 
 
Cash and cash 
 equivalents 
 at end of 
 period           $                        7,428   $                      12,042 
Restricted 
 cash at end 
 of period                                    --                              25 

Cash, cash 
 equivalents 
 and 
 restricted 
 cash at end 
 of period        $                        7,428   $                      12,067 
                ================================  ============================== 
 
Supplemental 
disclosure of 
non-cash 
investing and 
financing 
activities: 
Conversion of 
 Series X 
 non-voting 
 convertible 
 preferred 
 stock into 
 common stock 
 shares         $                             --   $                      44,826 
 

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SOURCE Rein Therapeutics, Inc.

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