Contineum Therapeutics, Inc. (NASDAQ: CTNM), a clinical-stage biopharmaceutical company focused on neuroscience, inflammation and immunology (NI&I) indications, has reaffirmed its key clinical development milestones while reporting first-quarter 2025 financial results. The company remains on track with its clinical programs, particularly its lead candidates PIPE-791 and PIPE-307.
"We remain on track to achieve all of our clinical operations milestones and significant clinical data readouts," said Carmine Stengone, CEO of Contineum Therapeutics. "Our potentially best-in-class/first-in-class LPA1 and M1 receptor antagonists support our vision of seeking better and new therapies for patients that have limited options today."
PIPE-791 Development Progress
PIPE-791, an LPA1 receptor antagonist, is advancing through multiple clinical trials. The company expects topline data from its Phase 1b positron emission tomography (PET) trial in the second quarter of 2025. This open-label, single-center trial is designed to measure the correlation of pharmacokinetics to receptor occupancy using PET imaging in healthy volunteers, as well as in patients with idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (PrMS).
Importantly, Contineum has completed the chronic toxicity studies for PIPE-791 required to support future Phase 2 trials. Based on these results, the company plans to initiate Phase 2 proof-of-concept clinical trials in IPF and PrMS in the second half of 2025.
PIPE-791 is also being evaluated for chronic pain. A Phase 1b randomized, double-blind, placebo-controlled, crossover trial initiated patient dosing in March 2025, with topline data anticipated in early 2026. This trial is assessing the drug's potential in treating chronic pain associated with osteoarthritis (OA) and low back pain (LBP).
PIPE-307 Clinical Development
The company's second lead candidate, PIPE-307, a selective inhibitor of the M1 receptor, is progressing in its Phase 2 VISTA trial for relapsing-remitting multiple sclerosis (RRMS). Topline data from this randomized, double-blind, placebo-controlled, multi-center, proof-of-concept trial is expected in the second half of 2025. The trial is designed to assess safety and efficacy in RRMS patients and to measure multiple clinical and imaging endpoints sensitive to changes in remyelination.
In a parallel development, Johnson & Johnson began recruiting an estimated 124 adult participants in December 2024 for a Phase 2 trial of PIPE-307/JNJ-89495120 in major depressive disorder (MDD). This collaboration stems from Contineum's global license and development agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company.
Pipeline Expansion
Beyond its lead programs, Contineum plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for CTX-343 in the second half of 2025, further expanding its clinical pipeline.
Financial Position
As of March 31, 2025, Contineum reported cash, cash equivalents, and marketable securities of $190.7 million. The company believes these resources are sufficient to fund its planned operations through 2027.
Research and development expenses for the first quarter were $13.7 million, representing a 76 percent increase from the same period in 2024. This increase was primarily attributed to higher clinical development expenses related to the advancement of the PIPE-791 and PIPE-307 programs, as well as increased employee-related costs.
General and administrative expenses were $4.4 million, a $2.2 million increase from the first quarter of 2024, driven mainly by higher stock-based compensation expense and employee-related costs.
The company reported a net loss of $16.0 million for the three months ended March 31, 2025, compared to $8.4 million for the prior-year quarter.
Strategic Focus
Contineum is advancing a pipeline of internally-developed programs targeting significant unmet medical needs. PIPE-791, as an LPA1 receptor antagonist, is being developed for multiple indications including IPF, PrMS, and chronic pain. PIPE-307, a selective inhibitor of the M1 receptor, is in clinical development for RRMS and MDD.
"With a solid balance sheet that carries us through 2027, we remain focused on executing against our clinical development objectives," Stengone emphasized, highlighting the company's commitment to bringing novel therapies to patients with limited treatment options.
The company's approach of developing oral small molecule therapies for NI&I indications positions it to potentially address significant unmet needs in these therapeutic areas, with multiple data readouts expected over the next 12-18 months that could provide important validation for its clinical programs.
