Pipeline Therapeutics is a clinical-stage biopharmaceutical company focused on precision neuroregeneration with programs addressing myelin restoration, synaptogenesis and axonal repair. Its flagship program, PIPE-307, is an oral, highly selective M1 muscarinic receptor antagonist that completed two Phase 1 trials in healthy volunteers and showed linear PK and tolerability. PIPE-307 has received FDA Investigational New Drug clearance to initiate clinical development in relapsing-remitting multiple sclerosis (RRMS). Pipeline has entered a global license and development agreement to broaden clinical evaluation of PIPE-307 in RRMS and other neurological disorders. The company will have the right to continue advancing PIPE-307 into a Phase 2 trial for RRMS under the agreement. Pipeline said the upfront payment and planned equity investments will strengthen its financial position and extend runway to continue advancing its small-molecule neuroregeneration portfolio. Pipeline Therapeutics focuses on development and commercialization of first-in-class small molecules targeting neuroregeneration, including synaptogenesis, remyelination and axonal repair. The company's lead clinical program, PIPE-505, is enrolling patients in a Phase 1/2a study for sensorineural hearing loss. A second program, PIPE-307, has initiated a Phase 1 healthy volunteer trial targeting multiple sclerosis. Pipeline holds a broader portfolio of programs addressing a range of neurological disorders. The company plans to use recent financing to advance PIPE-505 and PIPE-307 as well as additional therapeutic candidates and for general corporate purposes. The company is based in San Diego. Pipeline Therapeutics focuses on developing and commercializing first-in-class small molecules that promote neuroregeneration, including synaptogenesis, remyelination and axonal repair. Its lead candidate, PIPE-505, is a small-molecule gamma secretase inhibitor entering a Phase 1b/2a study to treat mild-to-moderate sensorineural hearing loss associated with cochlear synaptopathy and is positioned to impact both audibility and speech intelligibility. The company is also advancing PIPE-307, a selective M1 receptor antagonist aimed at remyelination to treat multiple sclerosis and other demyelinating disorders by regenerating myelin around axons. Pipeline plans to use the financing proceeds to advance its portfolio and move multiple programs into the clinic. A Phase 1b/2a study of PIPE-505 was expected to begin in 4Q 2019 with topline results expected in late 2020. The company communicates progress from San Diego and emphasizes addressing high unmet medical needs across neurological indications.

Total raised

$135M

Funding rounds

3

Latest round

Equity

Latest activity

Apr 2023