Contineum Therapeutics Inc — Current Report (Form 8-K)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Registrant’s telephone number, including area code)

 

 

 

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:

 

 

 

 

 

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

 

 

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.  ☐

 

 

 

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. 

 

 

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.

 

 

(d)  Exhibits.

 

    

 

 

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