Zynerba Hopes For Zygel Updates In 2021

Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) reported financial results for the first quarter ended March 31, 2021. As an emerging biotech company, Zynerba does not have revenue at this time as it develops drugs. Research and development expenses were $4.6 million for the first quarter of 2021, including stock-based compensation of $0.6 million. General and administrative expenses were $3.3 million in the first quarter of 2021, including stock-based compensation expense of $0.6 million.

The net loss for the first quarter of 2021 was $8.0 million with a basic and diluted loss per share of $(0.20). Zynerba beat the Estimize EPS Consensus by $0.01 by reporting a net loss per share of ($0.20).

“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,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “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.”

Fragile X Update

Wither regards to Fragile X, Zynerba said it expects to initiate RECONNECT (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), a pivotal, multi-national confirmatory Phase 3 trial of Zygel in children and adolescents with FXS, in 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 be an 18-week trial which will enroll approximately 200 children and adolescents of which approximately 160 patients will have complete (100%) methylation of their FMR1 gene and approximately 40 patients will have partial methylation of their FMR1 gene.

As of March 31, 2021, cash and cash equivalents were $93.1 million, compared to $59.2 million as of December 31, 2020. Zynerba said it believes that the company’s cash and cash equivalents as of March 31, 2021, are sufficient to fund operations and capital requirements well into the first half of 2024.

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