Contineum Therapeutics details Phase 2 IPF trial for PIPE-791

Accepted by SEC EDGAR 12/11/2025 - 04:01 PM EST Learn about SEC filing dates

Rhea-AI Filing Summary

Contineum Therapeutics, Inc. reported that on December 8, 2025 it submitted details of its global Phase 2 clinical trial of PIPE-791 for idiopathic pulmonary fibrosis to the ClinicalTrials.gov Protocol Registration and Results System, with posting to follow PRS approval.

The 26-week, international, randomized, dose-ranging, double-blind, placebo-controlled study will evaluate once-daily PIPE-791 in about 324 IPF patients, focusing on safety and tolerability and the change from baseline in absolute forced vital capacity at week 26.

The company’s trial design and launch strategy draw on prior regulatory engagement and completed Phase 1 studies, and it expects to begin the trial internationally and add countries as regulatory approvals are obtained, with completion anticipated in June 2028.

Insights

Biotech clinical development analyst

Contineum advances PIPE-791 into a global Phase 2 IPF trial, but outcome, timing and approvals remain subject to significant clinical and regulatory risks.

Contineum Therapeutics has submitted details for a global Phase 2 trial of PIPE-791 in idiopathic pulmonary fibrosis to the ClinicalTrials.gov PRS on December 8, 2025. The planned 26-week, international, randomized, dose-ranging, double-blind, placebo-controlled study will test once-daily dosing in about 324 patients, assessing safety and tolerability and change from baseline in absolute forced vital capacity at week 26.

The company states that the trial design and launch strategy were informed by regulatory engagement on an earlier draft protocol and by completed Phase 1 clinical trials. It expects to start the trial internationally and add countries as regulatory approvals become available, with trial completion anticipated in June 2028, indicating a multi-year clinical program before pivotal data could emerge.

The forward-looking discussion highlights substantial risks, including the uncertainty of clinical drug development, the lengthy and unpredictable process for obtaining protocol and product approvals, the possibility that Phase 1 results may not predict Phase 2 outcomes, and risks from adverse side effects, third-party reliance, manufacturing, competition and funding sufficiency. Actual results for PIPE-791 and the IPF program will depend on how these factors evolve over the course of the planned Phase 2 trial.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Contineum Therapeutics (CTNM) disclose about PIPE-791?

Contineum Therapeutics disclosed that on December 8, 2025 it submitted details of its global Phase 2 clinical trial of PIPE-791 for idiopathic pulmonary fibrosis to the ClinicalTrials.gov Protocol Registration and Results System, with the trial information to be posted after PRS approval.

How is the Phase 2 PIPE-791 trial for IPF designed?

The PIPE-791 Phase 2 trial in IPF is a 26-week, international, randomized, dose-ranging, double-blind, placebo-controlled study evaluating once-daily dosing in patients with idiopathic pulmonary fibrosis.

How many patients will be enrolled in Contineum Therapeutics' PIPE-791 Phase 2 IPF trial?

The company expects to enroll approximately 324 subjects globally in the Phase 2 clinical trial of PIPE-791 for idiopathic pulmonary fibrosis.

What is the main efficacy endpoint in the PIPE-791 Phase 2 IPF trial?

The trial is designed to assess safety and tolerability, as well as efficacy measured by the change from baseline in absolute forced vital capacity (FVC) at week 26.

When does Contineum Therapeutics expect to complete the PIPE-791 Phase 2 trial?

Contineum Therapeutics expects the Phase 2 clinical trial of PIPE-791 in idiopathic pulmonary fibrosis to be completed in June 2028.

What informed the design and launch strategy of the PIPE-791 Phase 2 trial?

The company states that the trial design and launch strategy were informed by regulatory engagement on an earlier draft protocol and by completed Phase 1 clinical trials of PIPE-791.

What key risks and uncertainties does Contineum Therapeutics highlight for PIPE-791's development?

The company cites risks including the uncertainty of clinical drug development, a lengthy and unpredictable regulatory approval process, the risk that earlier trial results may not predict future outcomes, possible adverse side effects, reliance on third parties, manufacturing risks, competition, and factors that could affect cash resources, operating results, trial timing and commercial potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001855175 0001855175 2025-12-08 2025-12-08

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): December 8, 2025

Contineum Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-42001		27-1467257
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

3565 General Atomics Court, Suite 200 San Diego, California		92121
(Address of principal executive offices)		(Zip Code)

(858) 333-5280

(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 obligation 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 240.14a-12)

☐ 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
Class A Common Stock, par value $0.001 per share		CTNM		The Nasdaq Global Market LLC (Nasdaq Global Select 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 Events.

On December 8, 2025, the Company submitted the details of its global Phase 2 clinical trial of PIPE-791 to treat patients with idiopathic pulmonary fibrosis (IPF) to the ClinicalTrials.gov Protocol Registration and Results System (PRS).  These trial details will be posted at https://clinicaltrials.gov upon approval by PRS. 

The trial is a 26-week, international, randomized, dose-ranging, double-blind, placebo-controlled Phase 2 clinical trial evaluating once-daily dosing of PIPE-791 in IPF patients.  The Company expects to enroll approximately 324 subjects globally in a trial designed to assess safety and tolerability, as well as efficacy measured by the change from baseline in absolute forced vital capacity (FVC) at week 26.  The Company expects the trial to be completed in June 2028.

The Company's trial design and launch strategy was informed by regulatory engagement on an earlier draft protocol and by the Company's completed Phase 1 clinical trials. The Company expects to commence the trial internationally, and to add countries as regulatory approvals become available. 

Forward-Looking Statements

This 8-K contains “forward-looking statements” of the Company within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the potential of the data from the Company's Phase 1 clinical trials to predict the tolerability, safety or dose selection and strategy for the Phase 2 clinical trial of PIPE-791 in IPF, the potential treatment impact of PIPE-791 and the success and timing of our clinical development strategies and plans to conduct our clinical trial of PIPE-791 in various countries globally, the estimated trial completion date for the Phase 2 clinical trial of PIPE-791 in IPF. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals for our clinical trial protocol and ultimate regulatory approval for PIPE-791, the ability of the Company to successfully develop PIPE-791, the Company’s ability to achieve its projected development goals in its expected timeframes, the risk that results from earlier trials may not be predictive of future trial results, risks related to adverse side effects, risks related to reliance on third party partners to conduct certain activities on the Company’s behalf, smaller than anticipated market opportunities for the Company’s products and product candidates, manufacturing risks, competition from other therapies or products, and other matters that could affect the sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the Company’s future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of the Company’s products and drug candidates. Additional risks and uncertainties that could affect the Company’s business, operations and results are included under the captions, “Risk Factors” and "Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company's periodic filings and in other filings that the Company makes with the Securities and Exchange Commission (SEC) from time to time, which are available on the Company’s website at http://www.contineum-tx.com/ under the Investors section and on the SEC’s website at www.sec.gov. Accordingly, readers should not rely upon forward-looking statements as predictions of future events. Except as required by applicable law, the Company undertakes no obligation to update publicly or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Item 9.01 Financial Statements and Exhibits.

(d)  Exhibits.

Exhibit No.		Description
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

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

Date: December 11, 2025

Contineum Therapeutics, Inc.
By:		/s/ Peter Slover
		Peter Slover
		Chief Financial Officer Principal Financial Officer and Principal Accounting Officer