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Zynerba says it's fully funded well into 2024; lays out plans for Zygel RECONNECT trial for Fragile X patients

The company reported that cash on hand increased 57% year-over-year from $59.2 million to $93.1 million

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The RECONNECT trial, planned for the third quarter, will enroll around 200 children and adolescents with Fragile X Syndrome

Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) (FRA:6ZY) told investors it believes it has sufficient cash to fund its operations well into the first half of 2024 after the company reported cash and equivalents of $93.1 million on hand at the end of the first quarter. 

In a business update for the three months ended March 31, the company reported that cash on hand increased 57% year-over-year from $59.2 million at the end of the first quarter last year. 

In the first quarter, the company sold and issued 10.2 million shares of common stock at a weighted average selling price of $4.22 per share, resulting in net proceeds of $42.2 million. 

READ: Zynerba receives FDA guidance on confirmatory Phase 3 trial of Zygel in patients with Fragile X syndrome

“We are committed to delivering on our important milestones in 2021 as we develop Zygel in multiple neuropsychiatric indications, including initiating a confirmatory pivotal Phase 3 trial, RECONNECT, in the third quarter of 2021, after productive dialogue and alignment with the FDA,” CEO Armando Anido said in a statement. “With a cash runway that takes us well into the first half of 2024, we believe that we are ideally positioned to continue our efforts to develop the first FDA-approved treatment for patients with Fragile X Syndrome (FXS).”

RECONNECT, or a “Randomized, Double-Blind, Placebo-Controlled, Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome,” is a Phase 3, 18-week trial planned for the third quarter of 2021. The trial is designed to confirm the positive results observed in a population of responders in the company’s previously conducted CONNECT-FX trial. 

The RECONNECT trial will enroll around 200 children and adolescents, roughly 160 of whom will have complete methylation of their FMR1 gene and 40 of whom will have partial methylation. 

The primary endpoint for the trial will be the change in the Aberrant Behavior Checklist-Community FXS Specific (ABC-CFXS) Social Avoidance subscale in patients, who have complete methylation of their FMR1 gene. Zynerba believes that the results, if positive, will be sufficient to support the submission of a New Drug Application (NDA) for Zygel in patients with FXS.

Additionally, as COVID-19-related restrictions in Australia are easing, Zynerba said it has resumed screening of patients for its 14-week open label Phase 2 INSPIRE trial in children and adolescents with genetically confirmed 22q, a disorder caused by a missing piece of the 22nd chromosome.

In the first half of 2021, Zynerba intends to discuss with the FDA data supporting the potential efficacy of Zygel in patients with Autism Spectrum Disorder, including the results of its Phase 2 BRIGHT trial in children and adolescents with moderate to severe ASD, to determine the regulatory path forward.

Also this year, Zynerba is conducting an observational trial that will help finalize target syndrome selection in one or more DEE syndromes in 2021. DEE is a heterogeneous group of epilepsy syndromes that may be associated with severe cognitive impairment and behavioral disturbances, the company said, and as a result, it will pursue individual syndromes rather than considering DEE as a single disorder or condition

Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com

Follow him on Twitter @andrew_kessel

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