PIPE-307 / Contineum Therap, J&J - LARVOL DELTA

Contineum Therapeutics Reports First-Quarter 2025 Financial Results; Affirms Key Clinical Development Milestones (Businesswire) - "Topline data from PIPE-791 Phase 1b positron emission tomography (PET) trial expected in the second quarter of 2025; PIPE-791 chronic toxicity studies completed to support future Phase 2 trials; Topline data from PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) anticipated in the second half of 2025...The Company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for CTX-343 in the second half of 2025."

Clinical data • Idiopathic Pulmonary Fibrosis • Lumbar Back Pain • Multiple Sclerosis • Osteoarthritis • Pain

Contineum Therapeutics Reports First-Quarter 2025 Financial Results... (Businesswire) - "Research and development expenses were $13.7 million, a 76 percent increase from the first quarter of 2024, largely due to higher clinical development expenses related to the advancement of the Company’s PIPE-791 and PIPE-307 programs and higher employee-related costs. The Company continues to believe its full-year 2025 research and development expenses will be significantly higher when compared to the full-year 2024 due to a meaningful increase in clinical development activity across its pipeline."

Commercial • Idiopathic Pulmonary Fibrosis • Multiple Sclerosis • Pain

Contineum Therapeutics Reports...Affirms Key Clinical Development Milestones (Businesswire) - "Contineum expects topline data from its PIPE-791 Phase 1b PET trial in the second quarter of 2025...Contineum plans to initiate Phase 2 proof-of-concept clinical trials in IPF and PrMS in the second half of 2025...The Company anticipates topline data from its PIPE-791 Phase 1b chronic pain trial in early 2026...Contineum expects topline data from its PIPE-307 Phase 2 VISTA RRMS trial in the second half of 2025...The Company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for CTX-343 in the second half of 2025."

Clinical data • IND • New P2 trial • Idiopathic Pulmonary Fibrosis • Multiple Sclerosis • Pain

Contineum Therapeutics Reports Fourth-Quarter 2024 Financial Results; Affirms Key Clinical Development Milestones (Businesswire) - "Research and development expenses were $13.0 million, a 62 percent increase from the fourth quarter of 2023, largely due to higher clinical development expenses related to the advancement of the Company’s...PIPE-307 programs and higher employee-related costs. The Company believes its full-year 2025 research and development expenses will be significantly higher when compared to the full-year 2024 due to a meaningful increase in clinical development activity across its pipeline."

Commercial • Multiple Sclerosis

Contineum Therapeutics Completes Enrollment in Phase 2 PIPE-307 VISTA Trial for the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS) (Businesswire) - "Contineum Therapeutics...announced that it has completed the targeted enrollment of 168 patients in its Phase 2 PIPE-307 VISTA trial....The Phase 2, randomized, double-blind, placebo-controlled, multi-center, proof-of-concept trial of PIPE-307 will assess safety and efficacy in RRMS patients. The trial is designed to measure multiple clinical and imaging endpoints sensitive to changes in remyelination in RRMS. Contineum anticipates that the last patient will complete the PIPE-307 VISTA trial in the third quarter of 2025."

Trial status • Multiple Sclerosis

VISTA: Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects with Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P2 | N=168 | Active, not recruiting | Sponsor: Contineum Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

Third Quarter 2024 Financial Results (Businesswire) - "Research and development expenses were $9.7 million for the three months ended September 30, 2024, compared to $6.5 million for the three months ended September 30, 2023. The increase of $3.2 million from period to period was primarily due to a $1.1 million increase in contract research organization costs primarily related to our on-going VISTA Phase 2 clinical trial for PIPE-307 for the potential treatment of RRMS, a $1.5 million increase in expenses for toxicology studies primarily for PIPE-791, a $0.6 million increase in personnel-related expense, and a $0.7 million increase in stock-based compensation. Partially offsetting these increases was a $0.7 million decrease in manufacturing expenses for PIPE-791."

Commercial • CNS Disorders • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Multiple Sclerosis • Pulmonary Disease

Contineum Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights (Businesswire) - "Research and Development Expenses. Research and development expenses were $7.9 million for the three months ended June 30, 2024, compared to $9.5 million for the three months ended June 30, 2023. The decrease of $1.6 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023 was primarily driven by a $4.8 million decrease in consulting and manufacturing expenses which were offset by increases in expenses related to our on-going Phase 2 clinical trial for PIPE-307 for RRMS and our completed Phase 1 healthy volunteer clinical study for PIPE-791, expenses for toxicology studies for PIPE-791 and personnel related costs."

Commercial • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease

Targeting the muscarinic M1 receptor with a selective, brain-penetrant antagonist to promote remyelination in multiple sclerosis. (PubMed, Proc Natl Acad Sci U S A) - "Further, PIPE-307 displays significant efficacy in the mouse experimental autoimmune encephalomyelitis model of MS as evaluated by quantifying disability, histology, electron microscopy, and visual evoked potentials. Together, these findings support targeting M1R for remyelination and support further development of PIPE-307 for clinical studies."

Journal • CNS Disorders • Immunology • Multiple Sclerosis • Solid Tumor

Contineum Therapeutics Announces Publication of Encouraging Data in the Proceedings of the National Academy of Sciences on PIPE-307, Its M1 Receptor Selective Inhibitor, in Clinical Development for Relapse-Remitting Multiple Sclerosis (Businesswire) - "Contineum Therapeutics...announced encouraging preclinical data on PIPE-307, a potentially first-in-class M1 receptor antagonist in development for patients with relapse-remitting multiple sclerosis (RRMS), were published online in the peer-reviewed journal, Proceedings of the National Academy of Science (PNAS)....'As observed in our preclinical studies, we believe that the immune-mediated effects of RRMS drive M1 signaling by increasing the local concentration of acetylcholine which in turn, limits OPC maturation and remyelination'..."

Preclinical • Multiple Sclerosis

VISTA: Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P2 | N=168 | Recruiting | Sponsor: Pipeline Therapeutics, Inc.

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

VISTA: Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P2 | N=168 | Recruiting | Sponsor: Pipeline Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Multiple Sclerosis

VISTA: Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P2 | N=168 | Not yet recruiting | Sponsor: Pipeline Therapeutics, Inc.

New P2 trial • CNS Disorders • Multiple Sclerosis • NEFL

"Pipeline Therapeutics Announces Global License and Development Agreement for Investigational Neuroscience Therapy, PIPE-307 https://t.co/fjlIyXagsB" (@NewsFromBW)

Clinical

Pipeline Therapeutics Announces Global License and Development Agreement for Investigational Neuroscience Therapy, PIPE-307 (Businesswire) - "Pipeline Therapeutics...announced today that it has entered into a global license and development agreement with Janssen Pharmaceutica NV (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the investigational compound, PIPE-307 to treat nervous system disorders. PIPE-307 is an oral, highly selective antagonist of the muscarinic M1 receptor, which has completed two Phase 1 clinical trials in healthy patients and has received Investigational New Drug clearance from the Food and Drug Administration (FDA) to initiate clinical development in relapsing-remitting multiple sclerosis (RRMS) patients."

Licensing / partnership • Immunology • Multiple Sclerosis

PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Pipeline Therapeutics, Inc.; Recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Multiple Sclerosis

PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers (clinicaltrials.gov) - P1; N=8; Recruiting; Sponsor: Pipeline Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Multiple Sclerosis