May 11, 2022 04:05 PM Eastern Daylight Time
SAN DIEGO--( BUSINESS WIRE )--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
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. Contacts

Pipeline Therapeutics to Present at Multiple Investor Conferences in May 2022

The "Sensorineural Hearing Loss - Pipeline Insight, 2022" report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Sensorineural Hearing Loss pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The assessment part of the report embraces, in depth Sensorineural Hearing Loss commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Sensorineural Hearing Loss collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights
Companies and academics are working to assess challenges and seek opportunities that could influence Sensorineural Hearing Loss R&D. The therapies under development are focused on novel approaches to treat/improve Sensorineural Hearing Loss. Sensorineural Hearing Loss Emerging Drugs Chapters
This segment of the Sensorineural Hearing Loss report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Sensorineural Hearing Loss Emerging Drugs
PIPE 505: Pipeline Therapeutics
PIPE-505, is Pipeline Therapeutics proprietary, locally delivered, gamma secretase inhibitor that targets two key regenerative pathways in the cochlea, the Netrin/DCC pathway for synaptic regeneration and the Notch pathway for outer hair cell regeneration. These pathways are linked to the two main areas of deficient auditory function in Sensorineural Hearing loss, intelligibility, and audibility, respectively. LY 3056480: Audion Therapeutics
Audion's lead candidate (LY 3056480) has undergone a thorough and extensive preclinical characterization in multiple model systems prior to initiation of the clinical studies. These studies include effects of the drug on damaged inner ear tissue, inner ear PK studies to determine drug exposure using different formulations and formal ototoxicity studies to exclude toxic effects on normal hair cells and inner ear tissues. The lead candidate (LY 3056480) has now completed clinical Phase 1 and Phase 2 testing, and delivered encouraging results that supported the advancement into Phase 2b studies. OTO 413: Otonomy
OTO-413 is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF) in development for the treatment of hearing loss. In December 2020, Otonomy, announced positive top-line results from a Phase 1/2 clinical trial of OTO-413, demonstrating that a single intratympanic injection of OTO-413 was well-tolerated and showed therapeutic activity across multiple speech-in-noise hearing tests. Otonomy is currently conducting a Phase 2a clinical trial for OTO-413, with top-line results expected early in the second quarter of 2022, and are also evaluating the safety of higher dosing. Sensorineural Hearing Loss: Therapeutic Assessment
This segment of the report provides insights about the different Sensorineural Hearing Loss drugs segregated based on the following parameters that define the scope of the report, such as:
Major Players in Sensorineural Hearing Loss
There are approx. 15+ key companies which are developing the therapies for Sensorineural Hearing Loss. The companies which have their Sensorineural Hearing Loss drug candidates in the most advanced stage, i.e. phase II include, Audion Therapeutics. Key Players

Sensorineural Hearing Loss Market Pipeline Research Report 2022: Comprehensive Insights About 15+ Companies and 15+ Pipeline Drugs - ResearchAndMarkets.com

April 05, 2022 04:05 PM Eastern Daylight Time
SAN DIEGO--( BUSINESS WIRE )--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. Contacts

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

-Company on track to begin enrolling patients in mid-2022
March 28, 2022 08:00 AM Eastern Daylight Time
SAN DIEGO--( BUSINESS WIRE )--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. Contacts

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

0
Pipe-307 demonstrated linear pharmacokinetic (PK) data consistent with pre-clinical modelling and was generally well tolerated at all doses in 70 healthy adult volunteers. Pipeline Therapeutics has reported positive clinical data from its recently completed Phase I clinical trial evaluating the safety and tolerability of Pipe-307 in healthy volunteers. Pipe-307, the company’s lead programme 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 I clinical results reported comprised multiple dose cohorts of Pipe-307 in a total of 70 healthy volunteer subjects. Pipe-307 demonstrated linear pharmacokinetic (PK) data consistent with pre-clinical modelling 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 I 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,” commented Dr Stephen Huhn, Chief Medical Officer and Senior Vice President of Clinical Development of Pipeline . “The results of the single- and multiple-ascending dose cohorts from the completed study demonstrate a favourable safety and PK profile, and we are pleased to have met our primary and secondary endpoints in this study. These encouraging Phase I 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, “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 I clinical trial of Pipe-307 was a randomised, 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 centre in Australia. Related topics

Positive Phase I results for Pipe-307 treatment for MS

Inception Therapeutics

Amira Pharmaceuticals

Merck & Co.

University of Chicago

COI Pharamaceuticals

Avelas Biosciences

aFraxis

Phenomix

Anadys Pharmaceuticals

Johnson & Johnson

Sophiris Bio

KPMG

StemCells

Stanford Health Care

University of California, San Francisco

Companies involved in the research, development, and commercialization of chemically- or biologically-derived therapeutic & theranostic drugs. Excludes vitamins/supplements, CROs/clinical trial services.

Biopharma Tech

Pipeline Therapeutics is a biopharmaceutical company focused on the development and commercialization of small molecules for neuroregeneration.

Date	Round	Amount	Investors	Revenue	Sources
2/11/2021	Series C	$80M	Brace Pharma Capital, Casdin Capital, Franklin Templeton, Perceptive Advisors, Red Tree Venture Capital, Samsara BioCapital, Sectoral Asset Management, Suvretta Capital Management, and Versant Ventures	0 FY undefined	20
12/18/2019	Series B	$99M	Subscribe to see more	0 FY undefined	10
7/13/2012	Series A		Subscribe to see more	0 FY undefined	0

Date	2/11/2021	12/18/2019	7/13/2012
Round	Series C	Series B	Series A
Amount	$80M	$99M
Investors	Brace Pharma Capital, Casdin Capital, Franklin Templeton, Perceptive Advisors, Red Tree Venture Capital, Samsara BioCapital, Sectoral Asset Management, Suvretta Capital Management, and Versant Ventures	Subscribe to see more	Subscribe to see more
Valuation
Revenue	0 FY undefined	0 FY undefined	0 FY undefined
Sources	20	10	0

Wells Fargo Success Story

3M Success Story

Platform Overview

Pipeline Therapeutics

Total Raised

Pipeline Therapeutics Funding, Pipeline Therapeutics Valuation & Pipeline Therapeutics Revenue

Discover the right solution for your team