RNTX 8-K: Press release furnished on Oct 9, 2025

Rhea-AI Filing Summary

Rein Therapeutics, Inc. furnished a current report on Form 8-K noting that the company issued a press release dated October 9, 2025. The filing indicates the press release was provided as an interactive data file within the Inline XBRL document and is signed by Brian Windsor, Ph.D., Chief Executive Officer.

No financial results, transactions, corporate developments, or other substantive disclosures are included in the text provided here; the filing appears limited to furnishing the press release.

Insights

Biopharma Regulatory Analyst

EMA cleared Phase 2 trial sites in EU for lead IPF drug; a constructive development with execution and data risks ahead.

Rein Therapeutics received authorization from the European Medicines Agency to initiate the Phase 2 "RENEW" trial of lead candidate LTI-03 for idiopathic pulmonary fibrosis, with sites in Germany and Poland. This marks a step from early-stage work into mid-stage clinical testing in the EU and expands the company’s clinical footprint. The disclosure is anchored by a press release dated October 9, 2025 attached as Exhibit 99.1.

What it means: EMA authorization enables site activation and patient enrollment activities, subject to standard trial start-up processes. This is favorable for the program’s progression, but it does not provide efficacy, safety, or enrollment details in this filing. Outcomes remain contingent on trial conduct, country-level oversight, and adherence to EU regulatory requirements.

Why it matters: Advancing to Phase 2 is a material inflection for a lead asset. Items to watch include first patient dosed, site activations in Germany and Poland, enrollment pace, and subsequent clinical readouts when disclosed. The next near-term marker is operational initiation following the October 2025 authorization.

NASDAQ false 0001420565 0001420565 2025-10-09 2025-10-09

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): October 9, 2025

REIN THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		001-38130		13-4196017
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(I.R.S. Employer Identification Number)

12407 N. Mopac Expy., Suite 250, #390

Austin, Texas 78758

(Address of principal executive offices)

(737) 802-1989

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions.

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14d-2(b)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock: Par value $.001		RNTX		Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐    

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Information.

On October 9, 2025, Rein Therapeutics, Inc. (the “Company”) issued a press release concerning it receipt of authorization from the European Medicines Agency to initiate the Company’s Phase 2 “RENEW” clinical trial, at sites in Germany and Poland, of its lead candidate, LTI-03, for the treatment of idiopathic pulmonary fibrosis. A copy of the press release is attached as Exhibit 99.1 hereto.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

The following exhibits are filed with this report:

Exhibit 99.1		The Company’s press release dated October 9, 2025
Exhibit 104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

				REIN THERAPEUTICS, INC.
Dated: October 9, 2025						/s/ Brian Windsor
						Brian Windsor, Ph.D.,
						Chief Executive Officer

FAQ

What did Rein Therapeutics (RNTX) file on Form 8-K?

The company furnished a press release dated October 9, 2025 via a Form 8-K and embedded the release as an interactive Inline XBRL data file.

Does the 8-K include financial results for Rein Therapeutics (RNTX)?

No. The provided filing text contains no financial statements, earnings data, or numerical operating metrics.

Who signed the Form 8-K for Rein Therapeutics (RNTX)?

Brian Windsor, Ph.D., Chief Executive Officer, is listed as the signing officer in the filing excerpt.

What is the date of the press release mentioned in the 8-K?

The press release is dated October 9, 2025.

Was any material transaction or corporate action disclosed in the filing?

No material transactions, acquisitions, financings, or executive changes are disclosed in the provided content.