Press Release: Rein Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Dow Jones
08 Apr

Rein Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

PR Newswire

AUSTIN, Texas, April 7, 2025

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 $(IPF.UK)$ 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. $(RNTX)$, 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

rein@argotpartners.com

212-600-1902

 
                        REIN THERAPEUTICS, INC. 
                       CONSOLIDATED BALANCE SHEETS 
             (In thousands, except share and per share data) 
 
                                           December 31,    December 31, 
                                               2024            2023 
                                          --------------  -------------- 
Assets 
Current assets: 
 Cash and cash equivalents                 $      12,865   $      17,313 
 Prepaid expenses and other current 
  assets                                             792             882 
 Restricted cash                                      --              25 
 Operating lease, right-of-use asset, 
  current portion                                     --              46 
                                              ----------      ---------- 
   Total current assets                           13,657          18,266 
Property and equipment, net                            1              19 
Goodwill                                           6,330           6,330 
Intangible assets                                 42,200          79,200 
Other non-current assets                               2           2,193 
                                              ----------      ---------- 
   Total assets                            $      62,190   $     106,008 
                                              ==========      ========== 
Liabilities, Convertible Preferred 
Stock and Stockholders' Equity 
Current liabilities: 
 Accounts payable                          $         911   $       1,190 
 Accrued expenses and other current 
  liabilities                                      4,838           3,147 
 Operating lease liabilities, current 
  portion                                             --              48 
                                              ----------      ---------- 
   Total current liabilities                       5,749           4,385 
Deferred tax liability                             1,772           3,326 
Other long-term liability                            277              -- 
                                              ----------      ---------- 
   Total liabilities                               7,798           7,711 
                                              ----------      ---------- 
Commitments and contingencies (Note 14) 
Convertible preferred stock, $0.001 par 
 value, 5,000,000 shares authorized at 
 December 31, 2024 and at December 31, 
 2023; 24,610 shares issued and 12,232 
 shares outstanding at December 31, 2024 
 and 24,610 shares issued and 
 outstanding at December 31, 2023                 45,005          91,410 
Stockholders' equity: 
 Common stock, $0.001 par value; 
  100,000,000 shares authorized at 
  December 31, 2024 and 45,000,000 at 
  December 31, 2023; 21,666,012 shares 
  and 4,885,512 shares issued and 
  outstanding at December 31, 2024 and 
  December 31, 2023, respectively                    108              91 
 Additional paid-in capital                      360,697         295,376 
 Accumulated other comprehensive loss               (18)            (63) 
 Accumulated deficit                           (351,400)       (288,517) 
                                              ----------      ---------- 
   Total liabilities, convertible 
    preferred stock and stockholders' 
    equity                                 $      62,190   $     106,008 
                                              ==========      ========== 
 
 
                       REIN THERAPEUTICS, INC. 
     CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS 
            (In thousands, except share and per share data) 
 
                                             Year Ended December 31, 
                                           --------------------------- 
                                                2024           2023 
                                           ---------------  ---------- 
Revenue                                     $           --  $       -- 
                                               -----------   --------- 
Operating expenses: 
 Research and development                           14,248       3,991 
 General and administrative                         13,864      11,357 
 Impairment loss on intangible assets               37,000          -- 
 Restructuring and other costs                          --         928 
                                               -----------   --------- 
   Total operating expenses                         65,112      16,276 
                                               -----------   --------- 
Loss from operations                              (65,112)    (16,276) 
Other income, net                                      685         544 
Income tax benefit                                   1,544          -- 
                                               -----------   --------- 
Net loss                                    $     (62,883)  $ (15,732) 
                                               ===========   ========= 
Net loss per share--basic and diluted       $       (3.51)  $   (3.42) 
                                               ===========   ========= 
Weighted average common shares 
 outstanding--basic and diluted                 17,938,899   4,598,715 
                                               ===========   ========= 
Comprehensive loss: 
Net loss                                    $     (62,883)  $ (15,732) 
Other comprehensive gain (loss): 
 Unrealized gain on investments, net of 
  tax of $0                                             45          48 
 Foreign currency translation adjustments               --        (63) 
                                               -----------   --------- 
   Total other comprehensive gain (loss)                45        (15) 
                                               -----------   --------- 
Total comprehensive loss                    $     (62,838)  $ (15,747) 
                                               ===========   ========= 
 
 
                       REIN THERAPEUTICS, INC. 
                 CONSOLIDATED STATEMENTS OF CASH FLOWS 
                            (In thousands) 
 
                                             Year Ended December 31, 
                                           --------------------------- 
                                                2024          2023 
                                           --------------  ----------- 
Cash flows from operating activities: 
Net loss                                    $    (62,883)  $  (15,732) 
Adjustments to reconcile net loss to net 
cash used in operating activities: 
 Depreciation and amortization expense                 63          119 
 Net amortization of premiums and 
  discounts on investments                             --           32 
 Stock-based compensation expense                   1,117        1,190 
 Gain on sale of property and equipment                --         (42) 
 Impairment loss on intangible assets              37,000           -- 
 Loss on disposition of property and 
  equipment                                            --            6 
 Changes in operating assets and 
 liabilities: 
   Prepaid expenses and other current 
    assets                                            134           51 
   Other assets                                     2,191          (3) 
   Accounts payable                                 (279)      (4,982) 
   Operating lease liabilities                       (48)         (65) 
   Accrued expenses and other current 
    liabilities                                     1,691        (382) 
   Other long-term liabilities                        277           -- 
   Deferred tax liabilities                       (1,554)           -- 
                                               ----------   ---------- 
 Net cash used in operating activities           (22,291)     (19,808) 
                                               ----------   ---------- 
Cash flows from investing activities: 
 Proceeds from sale of property and 
  equipment                                            --           42 
 Proceeds from sales or maturities of 
  investments                                          --       16,250 
 Acquisition, net of cash acquired                     --         (96) 
                                               ----------   ---------- 
 Net cash provided by investing 
  activities                                           --       16,196 
                                               ----------   ---------- 
Cash flows from financing activities: 
 Proceeds from issuance of common stock, 
 net of offering costs                             10,645           -- 
 Proceeds from issuance of common stock 
 in connection with stock option 
 exercises                                            143           -- 
 Proceeds from issuance of warrants, net 
 of offering costs                                  7,030           -- 
 Proceeds from the PIPE Financing                      --       15,794 
                                               ----------   ---------- 
 Net cash provided by financing 
  activities                                       17,818       15,794 
                                               ----------   ---------- 
 Effect of exchange rate changes on cash 
  and cash equivalents                                 --         (63) 
Net (decrease) increase in cash, cash 
 equivalents and restricted cash                  (4,473)       12,119 
Cash, cash equivalents and restricted 
 cash at beginning of year                         17,338        5,219 
                                               ----------   ---------- 
Cash, cash equivalents and restricted 
 cash at end of year                        $      12,865  $    17,338 
                                               ==========   ========== 
 
Cash and cash equivalents at end of year    $      12,865  $    17,313 
Restricted cash at end of year                         --           25 
                                               ----------   ---------- 
Cash, cash equivalents and restricted 
 cash at end of year                        $      12,865  $    17,338 
                                               ==========   ========== 
 
Supplemental disclosure of non-cash 
investing and financing activities: 
Conversion of Series X non-voting 
 convertible preferred stock into common 
 stock shares                               $      46,405  $        -- 
Unrealized gain on short-term investments   $          --  $        48 
Fair value of common shares issued in the 
 Lung Acquisition                           $          --  $       403 
Fair value of Series X Preferred Stock 
 issued in the Lung Acquisition             $          --  $    74,615 
Fair value of options assumed in the Lung 
 Acquisition                                $          --  $     1,050 
Fair value of warrants assumed in the 
 Lung Acquisition                           $          --  $       627 
 

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SOURCE Rein Therapeutics, Inc.

 

(END) Dow Jones Newswires

April 07, 2025 16:17 ET (20:17 GMT)

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