Contineum depression drug fails Phase 2 goal
Contineum Therapeutics, Inc. (CTNM) reported that its Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 in major depressive disorder did not meet its primary efficacy endpoint.
Rhea-AI Filing Summary
Contineum Therapeutics, Inc. (CTNM) reported that its Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 in major depressive disorder did not meet its primary efficacy endpoint. The study evaluated improvement from baseline in Montgomery-Åsberg Depression Rating Scale total score at Day 5 versus placebo. JNJ-5120/PIPE-307 was reported to be well tolerated with no new safety signals. Johnson & Johnson, which is developing the drug under a global license and development agreement with Contineum, is continuing to analyze the Phase 2 data, including prespecified exploratory endpoints, to assess the clinical relevance of the findings and determine potential next steps.
Positive
- JNJ-5120/PIPE-307 showed a favorable safety profile, with Contineum reporting that the drug was well-tolerated and that no new safety signals were observed in the Phase 2 MOONLIGHT-1 trial.
- Johnson & Johnson remains engaged with the program, continuing to evaluate MOONLIGHT-1 data, including prespecified exploratory endpoints, to assess clinical relevance and possible next steps for JNJ-5120/PIPE-307.
Negative
- Phase 2 MOONLIGHT-1 trial failed its primary efficacy endpoint for JNJ-5120/PIPE-307 in major depressive disorder, a setback for one of Contineum’s key partnered clinical programs.
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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.
Key Figures
Trial phase: Phase 2
Primary endpoint time point: Day 5
ClinicalTrials.gov identifier: NCT06785012
+1 more
4 metrics
Trial phase
Phase 2
MOONLIGHT-1 study of JNJ-5120/PIPE-307 in major depressive disorder
Primary endpoint time point
Day 5
Change from baseline in MADRS total score versus placebo
ClinicalTrials.gov identifier
NCT06785012
Registration for the MOONLIGHT-1 trial
Announcement date
September 14, 2026
Date Contineum reported MOONLIGHT-1 primary endpoint results
Key Terms
Montgomery-Åsberg Depression Rating Scale (MADRS), major depressive disorder, randomized, double-blind, multicenter, placebo-controlled, proof-of-concept trial, +1 more
5 terms
Montgomery-Åsberg Depression Rating Scale (MADRS) medical
"evaluated improvement from baseline in the Montgomery-Åsberg Depression Rating Scale"
A 10-question clinician-rated scale that measures the severity of depressive symptoms and tracks changes over time, often used in clinical trials as a standardized “thermometer” for depression. Investors watch MADRS results because improvements or lack of change can drive trial success, regulatory decisions and ultimately a drug’s commercial prospects, much like an exam score signals whether a new product meets expectations.
major depressive disorder medical
"monotherapy in adult participants with major depressive disorder"
A clinical condition characterized by persistent, severe low mood, loss of interest in daily activities, and reduced ability to function at work or home, lasting weeks or longer. It matters to investors because it drives demand for treatments and mental health services, affects workforce productivity and absenteeism, influences health-care and insurance costs, and shapes risks and opportunities for companies developing drugs, therapies or workplace programs—like a long-lasting storm that lowers economic output.
randomized, double-blind, multicenter, placebo-controlled medical
"a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept trial"
proof-of-concept trial medical
"placebo-controlled, proof-of-concept trial evaluating the efficacy"
A proof-of-concept trial is an early clinical study that tests whether a new drug or medical treatment produces the intended effect in people; think of it as a prototype demo that checks if the idea actually works in real patients. For investors it matters because positive results lower scientific and commercial risk, increase the likelihood of further development and regulatory approval, and often trigger share-price moves or new financing, while negative results can sharply reduce a project’s value.
LPA1 receptor antagonist medical
"PIPE-791 is an LPA1 receptor antagonist in clinical development"
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Contineum Therapeutics (CTNM) announce about the MOONLIGHT-1 Phase 2 trial?
Contineum announced that the Phase 2 MOONLIGHT-1 trial of JNJ-5120/PIPE-307 in adults with major depressive disorder did not achieve its primary efficacy endpoint, which was change in MADRS total score at Day 5 versus placebo.
How did JNJ-5120/PIPE-307 perform on safety in the MOONLIGHT-1 study for CTNM?
Contineum reported that JNJ-5120/PIPE-307 was well-tolerated in the MOONLIGHT-1 trial, with no new safety signals identified, indicating an acceptable safety and tolerability profile in this Phase 2 study.
What is Johnson & Johnson’s role in developing JNJ-5120/PIPE-307 with CTNM?
JNJ-5120/PIPE-307 is being developed by Johnson & Johnson under a global license and development agreement with Contineum. Johnson & Johnson continues to evaluate MOONLIGHT-1 data and assess the totality and clinical relevance of the findings.
What was the primary endpoint of Contineum’s MOONLIGHT-1 Phase 2 trial?
The primary endpoint was improvement from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 5 compared with placebo in adult participants with major depressive disorder.
What type of study design did CTNM use in the MOONLIGHT-1 trial?
MOONLIGHT-1 was a Phase 2, randomized, double-blind, multicenter, placebo-controlled, proof-of-concept trial evaluating the efficacy, safety and tolerability of JNJ-5120/PIPE-307 as monotherapy in adult participants with major depressive disorder.
Where can investors find more information about CTNM’s MOONLIGHT-1 trial?
More information on the MOONLIGHT-1 trial is available at ClinicalTrials.gov under identifier NCT06785012, as referenced by Contineum in its disclosure.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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): September 14, 2026
______________________________________________________________________
(Exact name of registrant as specified in its charter)
______________________________________________________________________
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (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 | ||||||||||||
The Nasdaq Global Market LLC ( | ||||||||||||||
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 September 14, 2026, Contineum Therapeutics, Inc. (“Contineum”) issued a press release in which it reported the results of the MOONLIGHT-1 Phase 2 clinical trial evaluating the efficacy, safety, and tolerability of JNJ-5120/PIPE-307 as a monotherapy in adult participants with major depressive disorder. Johnson & Johnson is developing JNJ-5120/PIPE-307 under a global license and development agreement with Contineum.
A copy of such press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | Press release dated September 14, 2026. | |||||||
| 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: September 14, 2026
| Contineum Therapeutics, Inc. | ||||||||
| By: | /s/ Peter Slover | |||||||
| Peter Slover | ||||||||
Chief Financial Officer Principal Financial Officer and Principal Accounting Officer | ||||||||
Exhibit 99.1
CONTINEUM THERAPEUTICS REPORTS PHASE 2 RESULTS FOR JNJ-5120/PIPE-307 FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
–Phase 2 MOONLIGHT-1 trial did not meet its primary efficacy endpoint
–Analyses of the data, including prespecified exploratory endpoints, are ongoing
SAN DIEGO – September 14, 2026 – Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated small molecule therapies for inflammatory and fibrotic diseases with significant unmet need, today announced that the MOONLIGHT-1 trial did not achieve its primary efficacy endpoint. The trial evaluated improvement from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 5 compared with placebo. JNJ-5120/PIPE-307 was well-tolerated with no new safety signals.
JNJ-5120/PIPE-307 is being developed by Johnson & Johnson under a global license and development agreement. Johnson & Johnson continues to evaluate the trial data, including data related to prespecified exploratory endpoints, and assess the totality and clinical relevance of the findings to inform next steps for JNJ-5120/PIPE-307.
The Phase 2, MOONLIGHT-1 study is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept trial evaluating the efficacy, safety and tolerability of JNJ-5120/PIPE-307 as monotherapy in adult participants with MDD. More information on this trial can be found at https://clinicaltrials.gov (NCT06785012).
About Contineum Therapeutics
Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for inflammatory and fibrotic diseases 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 and chronic pain. PIPE-307 is a selective inhibitor of the M1 receptor in clinical development by Johnson & Johnson for major depressive disorder. For more information, please visit www.contineum-tx.com.
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, implied or express statements regarding the pharmacological properties, safety, tolerability, clinical response and efficacy of JNJ-5120/PIPE-307 and statements regarding Johnson & Johnson’s plans to further assess the results of its Phase 2, MOONLIGHT-1 study and to consider next steps for JNJ-5120/PIPE-307. 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, events, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the 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 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 FDA 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 Company may use its capital resources sooner than expected and they may be insufficient to allow the Company to achieve its anticipated milestones; 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; the Company’s reliance, pursuant to a global license and development agreement, upon Janssen Pharmaceutica NV, a Johnson & Johnson company, to develop, in its sole discretion, PIPE-307 for MDD or for any other indication; the restrictions contained in the Company’s global license and development agreement with Janssen Pharmaceutica NV limiting the Company’s access to, and restricting the Company from disclosing, certain information regarding the development of PIPE-307; 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 ability to operate in a competitive industry and compete successfully against competitors that have greater resources than the Company does; 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 conflicts 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 www.contineum-tx.com under the Investor 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.
Contact
Steve Kunszabo
Contineum Therapeutics
Senior Director, Investor Relations & Corporate Communications
858-649-1158
skunszabo@contineum-tx.com