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Pipeline Therapeutics to Present at the 2022 Jefferies Global Healthcare Conference

SAN DIEGO, May 25/26, 2022 – Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, announced today that company management will present at the Jefferies Global Healthcare Conference taking place June 8-10, 2022 in New York, NY.  Carmine Stengone, Pipeline’s President and CEO, will present a company overview on Thursday, June 9, 2022 at 10:00 am ET.  Company management will also participate in one-on-one meetings with investors during the conference.

About Pipeline Therapeutics
Pipeline Therapeutics is a clinical-stage biopharmaceutical company pioneering the development and commercialization of first-in-class therapies for precision neuroregeneration including myelin restoration, synaptogenesis and axonal repair.  The Company has a broad pipeline of programs to address CNS and neuro-otology conditions. Its flagship program, PIPE-307, has completed a Phase 1 clinical trial in healthy volunteers and has received IND clearance from the FDA to initiate a Phase 1b/2a trial in relapsing-remitting MS patients.  For more information, please visit www.pipelinetherapeutics.com and engage with us on LinkedIn.

Company Contact:
Peter Slover
CFO
ir@pipeline-tx.com

Investor Contact:
Amy Conrad
858-914-1962
amy@juniper-point.com

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Pipeline Therapeutics to Present at Multiple Investor Conferences in May 2022

SAN DIEGO, May 5, 2022 – Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, announced today that company management will present at the following investor conferences:

  • 2022 RBC Capital Markets Global Healthcare Conference
    • Wednesday, May 18, 2022 at 8:00 am ET
  • UBS Global Healthcare Conference
    • Wednesday, May 25, 2022 at 8:30 AM ET

About Pipeline Therapeutics

Pipeline Therapeutics is a clinical-stage biopharmaceutical company pioneering the development and commercialization of first-in-class therapies for precision neuroregeneration including myelin restoration, synaptogenesis and axonal repair.  The Company has a broad pipeline of programs to address CNS and neuro-otology conditions. Its flagship program, PIPE-307, has completed a Phase 1 clinical trial in healthy volunteers and has received IND clearance from the FDA to initiate a Phase 1b/2a trial in relapsing-remitting MS patients.  For more information, please visit www.pipelinetherapeutics.com and engage with us on LinkedIn.

Company Contact:
Peter Slover
CFO
ir@pipeline-tx.com

Investor Contact:
Amy Conrad
858-914-1962
amy@juniper-point.com

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Pipeline Therapeutics to Present at the 21st Annual Virtual Needham Healthcare Conference

SAN DIEGO, April 5, 2022 – Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that company management will present at the 21st Annual Virtual Needham Healthcare Conference, taking place from April 11-14, 2022.  Carmine Stengone, Pipeline’s President and CEO, will present a company overview on April 13, 2022 at 4:30 pm ET.  Company management will also participate in one-on-one meetings with investors during the conference.

About Pipeline Therapeutics

Pipeline Therapeutics is a clinical-stage biopharmaceutical company pioneering the development and commercialization of first-in-class therapies for precision neuroregeneration including myelin restoration, synaptogenesis and axonal repair.  The Company has a broad pipeline of programs to address CNS and neuro-otology conditions. Its flagship program, PIPE-307, has completed a Phase 1 clinical trial in healthy volunteers and has received IND clearance from the FDA to initiate a Phase 1b/2a trial in relapsing-remitting MS patients.  For more information, please visit www.pipelinetherapeutics.com and engage with us on LinkedIn.

Company Contact:
Peter Slover
CFO
ir@pipeline-tx.com

Investor Contact:
Amy Conrad
858-914-1962
amy@juniper-point.com

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Pipeline Therapeutics Receives IND Clearance from FDA to Initiate Phase 1b/2a Study of PIPE-307 in Patients with Relapsing-Remitting Multiple Sclerosis 

-Company on track to begin enrolling patients in mid-2022

SAN DIEGO, March 28, 2022 – Pipeline Therapeutics, a clinical-stage biopharmaceutical  company pioneering precision neuroregeneration, today announced that the U.S. Food and Drug Administration (FDA) cleared the company to initiate its Phase 1b/2a clinical trial of PIPE-307 in patients with relapsing-remitting multiple sclerosis (RRMS).  Currently, there are no approved medicines that support myelin restoration, which represents a significant unmet medical need in the treatment of multiple sclerosis (MS). 

PIPE-307, the company’s lead program for myelin restoration, is an oral, highly selective antagonist of the muscarinic M1 receptor that is being developed for the treatment of MS.  The Company recently completed multiple Phase 1 studies of PIPE-307 in healthy volunteers, including a single and multiple-ascending dose study to evaluate safety and pharmacokinetics, and a positron emission tomography (PET) study to determine M1 receptor occupancy and clearance in the brain after a single dose of PIPE-307.  Results from the PET study demonstrate that doses tested in the Phase 1 study achieve a level of uptake in the human brain that have been associated with remyelination observed in preclinical studies. 

“FDA clearance to initiate our Phase 1b/2a clinical study of PIPE-307 is a major regulatory milestone for Pipeline, as it allows us to proceed with the evaluation of PIPE-307 in RRMS patients,” said Carmine Stengone, President and CEO of Pipeline.  “Today, approved medicines for MS patients are focused on immune modulation but do not address the fundamental MS disease pathology that leads to long-term decline in neurological function – chronic demyelination.  Our objective with PIPE-307 is to develop the first effective treatment that can restore myelin and improve outcomes for patients.”  

Stephen Huhn, M.D., Chief Medical Officer and Senior Vice President of Clinical Development of Pipeline, added, “We are excited to initiate the Phase 1b/2a study of PIPE-307 in RRMS patients, which follows on the heels of positive data from our Phase 1 studies.  The Phase 1b/2a study is designed to primarily assess the safety and tolerability of two different doses of PIPE-307 compared to placebo in RRMS patients, and to explore the use of neurophysiological, visual and radiological measures of remyelination. We remain on track to commence patient dosing in mid-2022.”

The Phase 1b/2a clinical trial of PIPE-307 will be conducted as a randomized, double-blind, placebo-controlled dose-ranging study in multiple sites across the US. The study will enroll approximately 45 patients who will undergo daily oral dosing over three months. The study is expected to start enrolling patients in mid-2022.

About PIPE-307 for Multiple Sclerosis

PIPE-307 is an oral, highly selective antagonist of the M1 muscarinic receptor commencing  clinical studies in MS patients. The Company recently completed multiple Phase 1 studies of PIPE-307 in healthy volunteers, including a single- and multiple-ascending dose study to evaluate safety and pharmacokinetics, and a PET study to determine the occupancy of brain M1 after a single dose of PIPE-307 in healthy volunteers. In these studies, PIPE-307 demonstrated linear pharmacokinetic (PK) data consistent with preclinical modeling and was generally well tolerated across all dose cohorts.  Importantly, analysis of a battery of neuropsychological measures, including tests involving psychomotor, attention, learning, and executive function, were administered in the Phase 1 study and showed no significant PK or dose related effects on cognitive function.  Results from the Phase 1 PET study demonstrated that doses tested in the Phase 1 SAD/MAD study achieve a level of uptake in the human brain that have been associated with remyelination observed in preclinical studies. 

In March 2022, the Company received clearance from the U.S. Food and Drug Administration  to proceed with a Phase 1b/2a study of PIPE-307 in RRMS patients.

About Pipeline Therapeutics

Pipeline Therapeutics is a clinical-stage biopharmaceutical company pioneering the development and commercialization of first-in-class therapies for precision neuroregeneration including myelin restoration, synaptogenesis and axonal repair.  The Company has a broad pipeline of programs to address CNS and neuro-otology conditions, and its flagship program, PIPE-307, has completed a Phase 1 clinical trial in healthy volunteers to support future studies in MS patients.  For more information, please visit www.pipelinetherapeutics.com and engage with us on LinkedIn.

Company Contact:
Peter Slover
CFO
ir@pipeline-tx.com

Investor Contact:
Amy Conrad
858-914-1962
amy@juniper-point.com

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Pipeline Therapeutics to Present at Upcoming March Investor Conferences

SAN DIEGO, March 14, 2022 – Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that company management will present at the following investor conferences:

  • 32nd Annual Oppenheimer Healthcare Conference
    • Tuesday, March 15th, 2022 at 1:20 pm ET
  • Stifel 2022 CNS Days
    • Monday, March 28th, 2022 at 8:45 AM ET

About Pipeline Therapeutics

Pipeline Therapeutics is a clinical-stage biopharmaceutical company pioneering the development and commercialization of first-in-class therapies for precision neuroregeneration including myelin restoration, synaptogenesis and axonal repair.  The Company has a broad pipeline of programs to address CNS and neuro-otology conditions, and its flagship program, PIPE-307, has completed a Phase 1 clinical trial in healthy volunteers to support future studies in MS patients.  For more information, please visit www.pipelinetherapeutics.com and engage with us on LinkedIn.

Company Contact:
Peter Slover
CFO
ir@pipeline-tx.com

Investor Contact:
Amy Conrad
858-914-1962
amy@juniper-point.com

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Pipeline Therapeutics Reports Positive Phase 1 Clinical Results for PIPE-307, a Neuroregenerative Therapeutic for the Treatment of Multiple Sclerosis

SAN DIEGO, March 10, 2022 – Pipeline Therapeutics, a clinical-stage biopharmaceutical  company pioneering precision neuroregeneration, today reported positive clinical data from its recently completed Phase 1 clinical trial evaluating the safety and tolerability of PIPE-307 in healthy volunteers.  PIPE-307, the company’s lead program for myelin restoration, is an oral, highly selective antagonist of the muscarinic M1 receptor that is being developed for the treatment of multiple sclerosis (MS).   Currently, there are no approved medicines that support myelin restoration, which represents a significant unmet medical need in the treatment of MS.

The Phase 1 clinical results reported today comprised multiple dose cohorts of PIPE-307 in a total of 70 healthy volunteer subjects. PIPE-307 demonstrated linear pharmacokinetic (PK) data consistent with preclinical modeling and was generally well tolerated across all dose cohorts.  Importantly, analysis of a battery of neuropsychological measures, including tests involving psychomotor, attention, learning, and executive function, were administered in the Phase 1 study and showed no significant PK or dose related effects on cognitive function.

“We believe that PIPE-307, as a first-in-class myelin restoration therapeutic, represents a differentiated and clinically-validated approach for the treatment of MS.  The results of the single- and multiple-ascending dose cohorts from the completed Phase 1 study demonstrate a favorable safety and PK profile, and we are pleased to have met our primary and secondary endpoints in this study,” said Stephen Huhn, M.D., Chief Medical Officer and Senior Vice President of Clinical Development of Pipeline Therapeutics. “These encouraging Phase 1 results give us great confidence to advance PIPE-307 into clinical studies with MS patients as soon as possible.”

Carmine Stengone, President and CEO of Pipeline, added, “PIPE-307 is our flagship program and we’re thrilled to have completed this first step in our approach to myelin restoration.  Multiple sclerosis is a devastating neurodegenerative disease that impacts almost three million people worldwide, and therapies that are designed to restore neuronal damage, like PIPE-307, are desperately needed. Our clinical plans remain on track and we look forward to evaluating PIPE-307 in MS patients.”

The completed Phase 1 clinical trial of PIPE-307 was a randomized, double-blind, placebo-controlled trial in 70 healthy adult volunteers. The trial was conducted in three parts: (1) a Single Ascending Dose (SAD) study, (2) a Multiple Ascending Dose (MAD) study, and (3) a selected SAD cohort in a fed state to evaluate the effect of food on bioavailability of PIPE-307.  The primary endpoint of the trial was to measure the safety and tolerability of PIPE-307, with a secondary endpoint measuring the effect of PIPE-307 on pharmacokinetics. This study was completed at a single center in Australia.

About PIPE-307 for Multiple Sclerosis

PIPE-307 is an oral, highly selective antagonist of the M1 muscarinic receptor in development for multiple sclerosis (MS).  In preclinical studies, PIPE-307 promoted remyelination by the differentiation and maturation of oligodendrocyte precursor cells, or OPCs, into oligodendrocytes, leading to restored neuronal function in a preclinical animal model of inflammatory demyelination. Preclinical treatment with PIPE-307 also led to a restoration in visual evoked potentials, or VEPs, a measure of electrical conduction velocity used to measure clinical disease progression in MS.  The Company expects to evaluate PIPE-307 in MS patients following the authorization of an Investigational New Drug (IND) by the US Food and Drug Administration.

About Pipeline Therapeutics

Pipeline Therapeutics is a clinical-stage biopharmaceutical company pioneering the development and commercialization of first-in-class therapies for precision neuroregeneration including myelin restoration, synaptogenesis and axonal repair.  The Company has a broad pipeline of programs to address CNS and neuro-otology conditions, and its flagship program, PIPE-307, has completed a Phase 1 clinical trial in healthy volunteers to support future studies in MS patients.  For more information, please visit www.pipelinetherapeutics.com and engage with us on LinkedIn.

Company Contact:

Peter Slover
Chief Financial Officer
ir@pipeline-tx.com

Investor Contact:
Amy Conrad
858-914-1962
amy@juniper-point.com