SAN DIEGO, December 13, 2023 – Pipeline Therapeutics, Inc. (the Company) announced today that it has changed its name to Contineum Therapeutics, Inc. (Contineum).  The Company chose Contineum (pronounced “Con-tin-E-um”) to represent its continuous dedication to the pursuit of scientific discovery and cutting-edge solutions designed to benefit patients. Contineum is focused on discovering and developing novel, oral small molecule therapies for neuroscience, inflammation and immunology (NI&I) indications with high unmet need. 

“Our goal is to create precision small molecules that can alter the course of clinical impairment in neurology, inflammation and immunology diseases.  The Company’s recent expansion into fibrotic diseases expands the potential of our pipeline and this name change is an exciting reflection of that progress,” said Carmine Stengone, CEO of Contineum. “We are building a nimble biopharmaceutical company with multiple clinical indications, large potential market opportunities such as IPF and multiple sclerosis, and a discovery platform targeting clinically validated mechanisms like LPA1 and M1 aimed at modulating innate pathways to restore function in NI&I indications. We look forward to continuing to grow Contineum under our new moniker to develop product candidates to improve patients’ lives.”

In conjunction with the corporate name change, the Company will have a new website address:  www.contineum-tx.com.

About Contineum Therapeutics

Contineum Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel, oral small molecule therapies for NI&I indications with high unmet need.  Contineum is focused on targeting biological pathways associated with specific clinical impairments, that the Company believes, once modulated, can demonstrably impact the course of disease. The Company has a pipeline of internally-developed programs to address multiple NI&I disorders, including PIPE-791, an LPA1 receptor antagonist, in Phase 1 for idiopathic pulmonary fibrosis  and progressive multiple sclerosis, and PIPE-307, a potentially first-in-class selective inhibitor of the M1 receptor in Phase 2 for relapse-remitting multiple sclerosis and with a Phase 2 for depression planned to initiate in mid-2024.  Contineum is developing PIPE-307 in collaboration with Johnson & Johnson Innovative Medicines.  In addition, Contineum is advancing discovery efforts targeting other NI&I indications where the Company’s internally-discovered molecules and approach may have therapeutic potential. 

Contineum is headquartered in San Diego, CA.  For more information, please visit www.contineum-tx.com or engage with us on LinkedIn.

Company Contact:
Peter Slover
CFO
pslover@contineum-tx.com

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

SAN DIEGO, October 4, 2023 – Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, announced today participation in the following upcoming investor conferences:

• Jefferies Biotech CNS/Neuro Summit, October 11-12, 2023, NY, NY
• Leerink Virtual Biopharma Private Company Connect, October 25-26, 2023

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 multiple CNS disorders.  In April 2023, Pipeline announced that it entered into a global license and development agreement with Janssen Pharmaceutica NV (Janssen) for its lead program, PIPE-307, a highly selective M1 antagonist, in central nervous system disorders.  The Company’s lead wholly-owned program, PIPE-791, an LPA1 receptor antagonist, is advancing through Phase 1 testing to support treatment of neurological diseases.

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
amy@juniper-point.com          

SAN DIEGO, September 7, 2023 – Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, announced today participation in the following upcoming investor conferences:

• Morgan Stanley 21^st Annual Global Healthcare Conference, September 11-13, 2023, NY, NY:
  • Pipeline management will participate in 1x1s with investors during the conference.

• UBS Biotechnology Private Company Virtual Symposium, September 20-21, 2023:
  • Carmine Stengone, Pipeline’s CEO, will participate in a fireside chat on Thursday, September 21, 2023, at 10:30am ET. 
  • Pipeline management will also participate in 1x1s 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 multiple CNS disorders.  In April 2023, Pipeline announced that it entered into a global license and development agreement with Janssen Pharmaceutica NV (Janssen) for its lead program, PIPE-307, a highly selective M1 antagonist, in central nervous system disorders.  The Company’s lead wholly-owned program, PIPE-791, an LPA1 receptor antagonist, is advancing through Phase 1 testing to support treatment of neurological diseases.

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
amy@juniper-point.com          

-Trial to evaluate PIPE-791 for safety and pharmacokinetics in healthy volunteers-

–  Expects enrollment to be completed by YE 2023-

SAN DIEGO, August 1, 2023 – Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that the first subject was dosed in the Phase 1 clinical trial of PIPE-791 in healthy volunteers.  PIPE-791 is a potent, selective and brain-penetrant small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1).

“Initiating dosing in this first in human study with PIPE-791 is a significant milestone for Pipeline that brings us one step closer to transforming the treatment of CNS indications by addressing both remyelination and neuroinflammation,” said Carmine Stengone, President and CEO of Pipeline.  “PIPE-791 is our lead, wholly owned program, and we look forward to evaluating its ability to inhibit the LPA1 receptor to bring benefit to people with MS and other neurological and systemic diseases.”

Last month, Pipeline announced that it received clearance from the U.S. Food and Drug Administration (FDA) to initiate the Phase 1 clinical trial of PIPE-791, which is a randomized, double-blind, placebo-controlled dose-ranging study expected to enroll approximately 80 healthy volunteer subjects.  

Stephen Huhn, M.D., Chief Medical Officer and Senior Vice President of Clinical Development of Pipeline, added, “The goal of this trial is to characterize the safety, tolerability and pharmacokinetic profile of PIPE-791 in healthy volunteers, and to inform dose selection in future clinical studies.  We expect to fully enroll the study by the end of 2023.”

About PIPE-791

The Company’s wholly owned program, PIPE-791, is in Phase 1 development for remyelination and neuroinflammation.

PIPE-791 is a potent, selective, brain-penetrant small molecule antagonist of the LPA1 receptor that has demonstrated activity in in vitro and in vivo models and was tolerated in IND-enabling studies.  Lysophosphatidic acid (LPA) is a pro-inflammatory lipid, upregulated in the plasma, peripheral blood mononuclear cells and cerebrospinal fluid of MS patients. LPA activates the G-protein coupled LPA1 receptor on both oligodendrocyte precursor cells (OPCs) and microglia resulting in a local neuroinflammatory response limiting remyelination.

PIPE-791 has demonstrated in vitro evidence of oligodendrocyte differentiation, myelination, and protection from cytokine-induced oligodendrocyte cell death. In pre-clinical in vivo models, PIPE-791 has demonstrated evidence of central nervous system LPA1 receptor occupancy, increased remyelination, and inhibition of neuroinflammation.

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 multiple CNS disorders.  In April 2023, Pipeline announced that it entered into a global license and development agreement with Janssen Pharmaceutica NV (Janssen) for its lead program, PIPE-307, a highly selective M1 antagonist, in central nervous system disorders.  The Company’s lead wholly-owned program, PIPE-791, an LPA1 receptor antagonist, is advancing through Phase 1 testing to support treatment of neurological diseases.

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

-Company on track to begin enrolling healthy volunteers in the second half of 2023-

SAN DIEGO, June 8, 2023 – 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 1 clinical trial of PIPE-791 in healthy volunteers.  The Company’s wholly owned program, PIPE-791, is a potent, selective and brain-penetrant small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1). LPA1 is a critical element in bioactive phospholipid signaling, and is a powerful mediator of both nervous system and systemic inflammatory conditions. Specifically, LPA1 inhibition has important therapeutic potential through augmentation of remyelination and mitigation of neuro-inflammation.  Multiple sclerosis (MS) is a leading indication for PIPE-791, as there are no currently approved medicines designed to prevent neuronal loss and mitigate clinical disability in MS patients .

“The FDA clearance of PIPE-791’s IND marks another significant milestone for Pipeline and demonstrates our team’s continued focus and commitment to bringing precision therapies to patients with neurological diseases,” said Carmine Stengone, President and CEO of Pipeline.  “PIPE-791 is our second clinical program and our first to address both remyelination and neuroinflammation.  We look forward to evaluating our first-in-class approach to LPA1 inhibition with PIPE-791, with the goal to deliver meaningful benefit to individuals with MS , as well as other neurological and systemic diseases.”

Stephen Huhn, M.D., Chief Medical Officer and Senior Vice President of Clinical Development of Pipeline, added, “We are excited to initiate the Phase 1 study of PIPE-791, which is designed to assess the safety and tolerability of PIPE-791 compared to placebo in healthy volunteers. We expect to commence dosing in the second half of 2023.”

The Phase 1 clinical trial of PIPE-791 will be conducted as a randomized, double-blind, placebo-controlled dose-ranging study, and enroll approximately 80 healthy volunteer subjects.  

About PIPE-791

The Company’s wholly owned program, PIPE-791, is advancing toward clinical development for remyelination and neuroinflammation. 

PIPE-791 is a potent, selective, brain-penetrant small molecule antagonist of the LPA1 receptor that has demonstrated activity in in vitro and in vivo models and was tolerated in IND-enabling studies.  Lysophosphatidic acid (LPA) is a pro-inflammatory lipid, upregulated in the plasma, peripheral blood mononuclear cells and cerebrospinal fluid of MS patients. LPA activates the G-protein coupled LPA1 receptor on both oligodendrocyte precursor cells (OPCs) and microglia resulting in a local neuroinflammatory response limiting remyelination.

PIPE-791 has demonstrated in vitro evidence of oligodendrocyte differentiation, myelination, and protection from cytokine-induced oligodendrocyte cell death. In pre-clinical in vivo models, PIPE-791 has demonstrated evidence of central nervous system LPA1 receptor occupancy, increased remyelination, and inhibition of neuroinflammation.

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 multiple CNS disorders.  In April 2023, Pipeline announced that it entered into a global license and development agreement with Janssen Pharmaceutica NV (Janssen) for its lead program, PIPE-307, a highly selective M1 antagonist, in central nervous system disorders.  The Company’s second program, PIPE-791, an LPA1 receptor antagonist, has received FDA clearance of its IND and is advancing into Phase 1 testing.

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

SAN DIEGO, May 25, 2023 – Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, announced today that Carmine Stengone, CEO of Pipeline, will present on June 9, 2023 at 12:15pm ET at the 2023 Jefferies Global Healthcare Conference, being held June 7-9, 2023 in New York, NY.  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 multiple CNS disorders.  In April 2023, Pipeline announced that it entered into a global license and development agreement with Janssen Pharmaceutica NV (Janssen) for its lead program, PIPE-307, a highly selective M1 antagonist, in nervous system disorders.  The Company’s second program, PIPE-791, an LPA1 receptor antagonist, has completed IND-enabling studies and is advancing toward clinical development for remyelination and neuroinflammation.
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
amy@juniper-point.com          

SAN DIEGO, May 4, 2023 – Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, announced today that Carmine Stengone, CEO of Pipeline, will present on Tuesday, May 16, 2023 at 4:05 pm ET at the RBC Global Healthcare Conference, being held May 16-17, 2023 in New York, NY.  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 multiple CNS disorders.  In April 2023, Pipeline announced that it entered into a global license and development agreement with Janssen Pharmaceutica NV (Janssen) for its lead program, PIPE-307, a highly selective M1 antagonist, in nervous system disorders.  The Company’s second program, PIPE-791, an LPA1 receptor antagonist, has completed IND-enabling studies and is advancing toward clinical development for remyelination and neuroinflammation.

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
amy@juniper-point.com          

– License and development agreement with Janssen leverages Pipeline’s expertise in precision neuroregeneration and Janssen’s development experience across nervous system disorders

SAN DIEGO, April 17, 2023 – Pipeline Therapeutics, (“Pipeline”), a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, 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.

“We are excited to announce this agreement, which is aligned with our vision to maximize the reach of PIPE-307 through clinical evaluation in RRMS and other neurological disorders,” said Carmine Stengone, President and CEO of Pipeline. “In addition, we are pleased that we will strengthen our financial position with the upfront payment from this agreement and equity investments from existing and new investors, enabling us to extend our runway and to continue advancing our portfolio in small molecule neuroregeneration.”

Under the terms of the agreement, Pipeline will grant Janssen a worldwide, exclusive license to research, develop and commercialize PIPE-307 in all indications. Pipeline will have the right to continue to advance PIPE-307 for the treatment of RRMS through conduct of a Phase 2 clinical trial.

Upon closing of the transaction, Pipeline will receive $50M in an upfront payment from Janssen and separately up to $25M in an equity investment from Johnson & Johnson Innovation – JJDC, Inc. and up to $25M in equity investments from Pipeline’s existing investors. Pipeline is also eligible to receive approximately $1 billion in success-based payments including clinical, regulatory and commercial milestones, as well as tiered double-digit royalty payments, which increase if the co-development option for PIPE-307 is exercised by Pipeline.

About PIPE-307 for Multiple Sclerosis

PIPE-307 is an oral, highly selective antagonist of the M1 muscarinic receptor commencing clinical studies in RRMS patients. The Company completed multiple Phase 1 studies of PIPE-307 in healthy patients, 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.

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 multiple CNS disorders. Its flagship program, PIPE-307, has completed two Phase 1 clinical trials – a SAD/MAD study and a PET study – in healthy volunteers, and has received Investigational New Drug clearance from the Food and Drug Administration to initiate clinical development 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
amy@juniper-point.com  

SAN DIEGO, April 12, 2023 – Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, announced today that Carmine Stengone, CEO of Pipeline, will present a company overview on Wednesday, April 19, 2023, at 3pm ET at the 22^nd Annual Needham Virtual Healthcare Conference.  Company management will also participate in virtual 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 multiple CNS disorders. Its flagship program, PIPE-307, has completed two Phase 1 clinical trials – a SAD/MAD study and a PET study – in healthy volunteers, and has received Investigational New Drug clearance from the Food and Drug Administration to initiate clinical development 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
amy@juniper-point.com