Rein Therapeutics Progress on LTI-03 Clinical Development

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

Corporate Updates

Fourth Quarter and Full Year 2024 Financial Results

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

REIN THERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

December 31, 2024
December 31, 2023

Assets

Current assets:
Cash and cash equivalents: $12,865 (2024), $17,313 (2023)
Prepaid expenses and other current assets: $792 (2024), $882 (2023)
Restricted cash: — (2024), $25 (2023)
Operating lease, right-of-use asset, current portion: — (2024), $46 (2023)
Total current assets: $13,657 (2024), $18,266 (2023)
Property and equipment, net: $1 (2024), $19 (2023)
Goodwill: $6,330 (2024), $6,330 (2023)
Intangible assets: $42,200 (2024), $79,200 (2023)
Other non-current assets: $2 (2024), $2,193 (2023)
Total assets: $62,190 (2024), $106,008 (2023)

Liabilities, Convertible Preferred Stock and Stockholders' Equity

Current liabilities:
Accounts payable: $911 (2024), $1,190 (2023)
Accrued expenses and other current liabilities: $4,838 (2024), $3,147 (2023)
Operating lease liabilities, current portion: — (2024), $48 (2023)
Total current liabilities: $5,749 (2024), $4,385 (2023)
Deferred tax liability: $1,772 (2024), $3,326 (2023)
Other long-term liability: $277 (2024), — (2023)
Total liabilities: $7,798 (2024), $7,711 (2023)
Commitments and contingencies (Note 14)
Convertible preferred stock: $45,005 (2024), $91,410 (2023)
Stockholders' equity:
Common stock: $108 (2024), $91 (2023)
Additional paid-in capital: $360,697 (2024), $295,376 (2023)
Accumulated other comprehensive loss: $(18) (2024), $(63) (2023)
Accumulated deficit: $(351,400) (2024), $(288,517) (2023)
Total liabilities, convertible preferred stock and stockholders' equity: $62,190 (2024), $106,008 (2023)

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: $— (2024), $— (2023)
Operating expenses:
Research and development: $14,248 (2024), $3,991 (2023)
General and administrative: $13,864 (2024), $11,357 (2023)
Impairment loss on intangible assets: $37,000 (2024), $— (2023)
Restructuring and other costs: $— (2024), $928 (2023)
Total operating expenses: $65,112 (2024), $16,276 (2023)
Loss from operations: $(65,112) (2024), $(16,276) (2023)
Other income, net: $685 (2024), $544 (2023)
Income tax benefit: $1,544 (2024), $— (2023)
Net loss: $(62,883) (2024), $(15,732) (2023)
Net loss per share—basic and diluted: $(3.51) (2024), $(3.42) (2023)
Weighted average common shares outstanding—basic and diluted: 17,938,899 (2024), 4,598,715 (2023)

Comprehensive loss:

Net loss: $(62,883) (2024), $(15,732) (2023)
Other comprehensive gain (loss):
Unrealized gain on investments, net of tax: $45 (2024), $48 (2023)
Foreign currency translation adjustments: $— (2024), $(63) (2023)
Total other comprehensive gain (loss): $45 (2024), $(15) (2023)
Total comprehensive loss: $(62,838) (2024), $(15,747) (2023)

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) (2024), $(15,732) (2023)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense: $63 (2024), $119 (2023)
Net amortization of premiums and discounts on investments: $— (2024), $32 (2023)
Stock-based compensation expense: $1,117 (2024), $1,190 (2023)
Gain on sale of property and equipment: $— (2024), $(42) (2023)
Impairment loss on intangible assets: $37,000 (2024), $— (2023)
Loss on disposition of property and equipment: $— (2024), $6 (2023)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets: $134 (2024), $51 (2023)
Other assets: $2,191 (2024), $(3) (2023)
Accounts payable: $(279) (2024), $(4,982) (2023)
Operating lease liabilities: $(48) (2024), $(65) (2023)
Accrued expenses and other current liabilities: $1,691 (2024), $(382) (2023)
Other long-term liabilities: $277 (2024), $— (2023)
Deferred tax liabilities: $(1,554) (2024), $— (2023)
Net cash used in operating activities: $(22,291) (2024), $(19,808) (2023)

Cash flows from investing activities:
Proceeds from sale of property and equipment: $— (2024), $42 (2023)
Proceeds from sales or maturities of investments: $— (2024), $16,250 (2023)
Acquisition, net of cash acquired: $— (2024), $(96) (2023)
Net cash provided by investing activities: $— (2024), $16,196 (2023)

Cash flows from financing activities:
Proceeds from issuance of common stock, net of offering costs: $10,645 (2024), $— (2023)
Proceeds from issuance of common stock in connection with stock option exercises: $143 (2024), $— (2023)
Proceeds from issuance of warrants, net of offering costs: $7,030 (2024), $— (2023)
Proceeds from the PIPE Financing: $— (2024), $15,794 (2023)
Net cash provided by financing activities: $17,818 (2024), $15,794 (2023)

Effect of exchange rate changes on cash and cash equivalents: $— (2024), $(63) (2023)
Net (decrease) increase in cash, cash equivalents and restricted cash: $(4,473) (2024), $12,119 (2023)
Cash, cash equivalents and restricted cash at beginning of year: $17,338 (2024), $5,219 (2023)
Cash, cash equivalents and restricted cash at end of year: $12,865 (2024), $17,338 (2023)
Cash and cash equivalents at end of year: $12,865 (2024), $17,313 (2023)
Restricted cash at end of year: $— (2024), $25 (2023)

Supplemental disclosure of non-cash investing and financing activities:

Conversion of Series X non-voting convertible preferred stock into common stock shares: $46,405 (2024), $— (2023)
Unrealized gain on short-term investments: $— (2024), $48 (2023)
Fair value of common shares issued in the Lung Acquisition: $— (2024), $403 (2023)
Fair value of Series X Preferred Stock issued in the Lung Acquisition: $— (2024), $74,615 (2023)
Fair value of options assumed in the Lung Acquisition: $— (2024), $1,050 (2023)
Fair value of warrants assumed in the Lung Acquisition: $— (2024), $627 (2023)

SOURCE Rein Therapeutics, Inc.