# EDGAR Filing Document

**Accession Number:** 0001855175
**File Stem:** 0001437749-25-029349
**Filing Date:** 2025-9
**Character Count:** 19576
**Document Hash:** 4bdf8c5b05c42766314ffee00805759d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-029349.hdr.sgml**: 20250918

**ACCESSION NUMBER**: 0001437749-25-029349

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 25

**CONFORMED PERIOD OF REPORT**: 20250918

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250918

**DATE AS OF CHANGE**: 20250918

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Contineum Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001855175
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 271467257
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42001
- **FILM NUMBER:** 251321818

**BUSINESS ADDRESS:**
- **STREET 1:** 3565 GENERAL ATOMICS COURT, SUITE 200
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121
- **BUSINESS PHONE:** (858) 333-5280

**MAIL ADDRESS:**
- **STREET 1:** 3565 GENERAL ATOMICS COURT, SUITE 200
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Pipeline Therapeutics, Inc.
- **DATE OF NAME CHANGE:** 20210405

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**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION** 

**Washington, D.C. 20549** 

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**FORM **8-K**

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**CURRENT REPORT** 

**Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934** 

**Date of Report (Date of earliest event reported): **September 18, 2025**

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## Contineum Therapeutics, Inc.
**(Exact name of registrant as specified in its charter)** 

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| | | |
|:---|:---|:---|
| **Delaware** | **001-42001** | **27-1467257** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

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| | |
|:---|:---|
| **3565 General Atomics Court, Suite 200**<br> **San Diego**, **California**  | <br> **92121** |
| **(Address of principal executive offices)** | **(Zip Code)** |

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**(**858**) **333-5280**

**(Registrant**'**s telephone number, including area code)** 

**N/A**

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

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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:

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| | | |
|:---|:---|:---|
| 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<br> (Nasdaq Global Select Market) |

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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 &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; ☒

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. ☐

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**Item 7.01 Regulation FD Disclosure.**

On September 18, 2025, the Company issued a press release titled "Contineum Therapeutics Reports Positive Topline Data from Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791." A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The Company from time to time presents and/or distributes to the investment community slide presentations to provide updates and summaries of its business. A copy of its "PIPE-791 Phase 1b PET Trial Topline Data Supplemental Information" slide presentation is being furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K.

The information under this Item 7.01, including Exhibit 99.1 and Exhibit 99.2 hereto, is being furnished herewith and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

**Item 8.01 Other Events.**

On September 18, 2025, the Company announced topline data from its Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791.

This Phase 1b, open label, single-center trial was designed to assess the correlation between pharmacokinetics (PK) and lysophosphatidic acid 1 (LPA1) receptor occupancy using PET imaging in healthy volunteers, as well as idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (PrMS) patients. 12 healthy volunteers and four PrMS patients participated in this trial. More information on this trial can be found at <u>https://clinicaltrials.gov</u> <u>(</u>NCT06683612<u>)</u>.

Selected topline brain PET data for healthy volunteers and PrMS patients is summarized below:

• A PK relationship between PIPE-791 exposure and LPA1 brain receptor occupancy (RO) was confirmed in healthy volunteers and PrMS patients.

• Plasma EC50 values 37 ng/mL at 24 hours and 12 ng/mL at 168 hours post-dose demonstrate sustained target engagement in healthy volunteers.

• The Company believes its planned doses for its future Phase 2 proof-of-concept clinical trials will exceed 90% target coverage at trough with once daily dosing.

*Forward-Looking Statements*

This Current Report on Form 8-K and certain materials furnished or filed herewith contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the Company's clinical trial and product development plans and timelines, including, but not limited to, those regarding the pharmacological properties, safety, tolerability and therapeutic potential of PIPE-791; the potential of the data from the Company's Phase 1b PET trial to predict dose selection, including whether the Company's planned dose selection for its future Phase 2 proof-of-concept clinical trials will exceed 90% target coverage at trough with once daily dosing, or to predict future clinical outcomes or results.

Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company's product candidate development activities and planned clinical trials; the Company's ability to execute on its strategy; positive results from any of its clinical studies may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; the Company's ability to fund operations. 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 <u>www.contineum-tx.com</u> under the Investor section and on the SEC's website at <u>www.sec.gov</u>. 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.

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press release dated September 18, 2025.](ex_860445.htm) |
| 99.2 | [PIPE-791 Phase 1b PET Trial Topline Data Supplemental Information slide presentation of Contineum Therapeutics, Inc.](ex_862024.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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&nbsp;&nbsp;&nbsp;&nbsp;

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**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: September 18, 2025

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| | |
|:---|:---|
| **Contineum Therapeutics, Inc.** | **Contineum Therapeutics, Inc.** |
| By: | <u>/s/ Peter Slover</u> |
|  | Peter Slover |
|  | Chief Financial Officer<br> *Principal Financial Officer and Principal Accounting Officer* |

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## Exhibit 99.1

**Exhibit 99.1**

![logo.jpg](logo.jpg)

**CONTINEUM THERAPEUTICS REPORTS POSITIVE TOPLINE DATA FROM PHASE 1B POSITRON EMISSION TOMOGRAPHY (PET) TRIAL OF PIPE-791**

*- PIPE-791 achieved high LPA1 brain receptor occupancy (RO) in healthy volunteers and progressive multiple sclerosis (PrMS) patients*

*- PIPE-791 showed a safety and tolerability profile consistent with previous clinical studies*

*- Topline data affirms planned doses for future Phase 2 clinical proof-of-concept trials*

SAN DIEGO – September 18, 2025 – Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced positive topline data from its PIPE-791 Phase 1b positron emission tomography (PET) trial. The trial met its primary objectives by demonstrating PIPE-791, the Company's novel, brain penetrant, small molecule antagonist of the lysophosphatidic acid 1 (LPA1) receptor, achieved high brain receptor occupancy (RO) in healthy volunteers and progressive multiple sclerosis (PrMS) patients with a clear pharmacokinetic (PK) correlation between drug exposure and receptor engagement. PIPE-791 also demonstrated a safety and tolerability profile consistent with the Company's previous clinical studies. Based on these data, the Company believes its planned doses for its future Phase 2 proof-of-concept clinical trials in idiopathic pulmonary fibrosis (IPF) and PrMS will exceed 90% target coverage at trough with once daily dosing.

"We are pleased by these results, which confirm that PIPE-791 achieves high, sustained brain RO," said Timothy Watkins, M.D., M.Sc., Chief Medical Officer and Head of Development, Contineum Therapeutics. "These trial data highlight the unique pharmacological properties of PIPE-791, enabling the potential for once-daily dosing for sustained target coverage. We believe showing target engagement in humans is an important, additional step that validates our compelling preclinical data and provides a solid foundation for advancing PIPE-791 into Phase 2 trials."

**<u>Selected Topline Brain PET Data for Healthy Volunteers and PrMS Patients</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• A PK relationship between PIPE-791 exposure and LPA1 brain RO was confirmed in healthy volunteers and PrMS patients.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Plasma EC50 values 37 ng/mL at 24 hours and 12 ng/mL at 168 hours post-dose demonstrate sustained target engagement in healthy volunteers.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Company believes its planned doses for its future Phase 2 proof-of-concept clinical trials will exceed 90% target coverage at trough with once daily dosing.

Although direct measurement of LPA1 RO in the lungs of healthy volunteers was not feasible in the Company's Phase 1b PET trial, likely due to low receptor expression in healthy volunteers combined with technical challenges associated with lung PET imaging, the Company's earlier preclinical studies have demonstrated a strong correlation between brain and lung RO.

"Based on the distribution pattern of PIPE-791, we believe the brain is an appropriate surrogate for predicting RO in the lungs," said Daniel Lorrain, Ph.D., Chief Scientific Officer, Contineum Therapeutics. "We are confident in the planned doses for our future Phase 2 proof-of-concept clinical trials based upon brain RO and our completed preclinical work."

This Phase 1b, open label, single-center trial was designed to assess the correlation between pharmacokinetics and LPA1 RO using PET imaging in healthy volunteers, as well as IPF and PrMS patients. 12 healthy volunteers and four PrMS patients participated in this trial. More information on this trial can be found at <u>https://clinicaltrials.gov</u> (NCT06683612).

**About Contineum Therapeutics**

Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally-developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis, progressive multiple sclerosis and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder. For more information, please visit <u>www.contineum-tx.com</u>.

**Forward-Looking Statements** 

*Certain statements contained in this press release, other than historical information, constitute forward-looking statements within the meaning of the federal securities laws. Forward-looking statements include, but are not limited to, statements regarding the Company's clinical trial and product development plans and timelines, including, but not limited to, those regarding the pharmacological properties, safety, tolerability and therapeutic potential of PIPE-791; the potential of the data from the Company's Phase 1b PET trial to predict dose selection, including whether the Company's planned dose selection for its future Phase 2 proof-of-concept clinical trials will achieve sustained or exceed 90% target coverage at trough with once daily dosing, or to predict future clinical outcomes or results; the Company's cash runway; the indications, anticipated benefits of, and market opportunities for the Company's drug candidates; the Company's business strategies and plans; and the quotations of the Company's management. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond the Company's control and may cause its actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. These risks and uncertainties, include, but are not limited to, the following: the Company is heavily dependent on the success of PIPE-791 and PIPE-307, both of which are in the early stages of clinical development, and neither of these drug candidates may progress through clinical development or receive regulatory approval; the results of earlier preclinical studies and clinical trials, including those conducted by third parties, may not be predictive of future results and unexpected adverse side effects or inadequate efficacy of the Company's drug candidates may limit their development, regulatory approval and/or commercialization; the timing and outcome of research, development and regulatory review is uncertain; the U.S. Food & Drug Administration or comparable foreign regulatory authorities may disagree as to the design or implementation of our proposed clinical trials; clinical trials and preclinical studies may not proceed at the time or in the manner expected, or at all; the potential for the Company's programs and prospects to be negatively impacted by developments relating to the Company's competitors, including the results of studies or regulatory determinations relating to the Company's competitors; risks associated with reliance on third parties to successfully conduct clinical trials and, in the case of PIPE-307, the Company's reliance, pursuant to a global license and development agreement, upon Janssen Pharmaceutica NV, a Johnson & Johnson company, to develop PIPE-307 for any other indication other than relapsing-remitting multiple sclerosis and, after completion of the Company's PIPE-307 Phase 2 VISTA trial, Janssen Pharmaceutica NV's decision, in its sole discretion, whether or not to further develop PIPE-307 for relapsing-remitting multiple sclerosis; the Company has incurred significant operating expenses since inception and it expects that its operating expenses will continue to significantly increase for the foreseeable future; the Company's license agreement with Janssen Pharmaceutica NV may not result in the successful development of PIPE-307; the Company may be unable to obtain, maintain and enforce intellectual property protection for its technology and drug candidates; and unstable market and economic conditions and military conflict may adversely affect the Company's business and financial condition and the broader economy and biotechnology industry. 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 <u>www.contineum-tx.com</u> under the Investor section and on the SEC's website at <u>www.sec.gov</u>. 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.*

***Contact***

Steve Kunszabo

Contineum Therapeutics

Senior Director, Investor Relations & Corporate Communications

858-649-1158

<u>skunszabo@contineum-tx.com</u>

## Exhibit 99.2

**Exhibit 99.2**

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