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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