Zynerba Pharmaceuticals Adds Autism, DiGeorge Syndrome To Pipeline

Zynerba Pharmaceuticals Inc ZYNE beat the consensus estimate for its fourth-quarter loss Monday and provided some highlights from its ongoing and upcoming trials.

What Happened

The company posted revenue of just $86,000 for the quarter ended Dec. 31, which was the only revenue recorded for the entire year. At the same time, Zynerba's net loss narrowed from $8.12 million or 60 cents per share a year earlier to $7.79 million or 44 cents per diluted share. 

Zynerba registered an increase in general and administrative expenses during the fourth quarter from $2.38 million a year earlier to $3.26 million. Research and development costs declined from $5.83 million to $4.88 million. In this way, Zynerba's total operating expenses inched down from $8.2 million to $8.13 million.

The company ended the quarter with cash and cash equivalents of $59.8 million, down from $62.5 million recorded at the end of December 2017. 

Why It's Important

Zynerba is conducting a number of studies evaluating its CBD-based transdermal gel candidate ZYN002, or Zygel.

The company said it is in the process of enrolling patients for its CONNECT-FX study that evaluates the efficacy and safety of Zygel in patients ages 3-17 with Fragile X syndrome. It expects to report top-line results from the study in the second half of 2019 and to submit a New Drug Application in the first half of 2020, with the potential for approval by the end of the year.  

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Zynerba said it completed enrollment in BELIEVE 1, an open-label, multidose Phase 2 trial that evaluates Zygel in children and adolescents with developmental and epileptic encephalopathies. The top-line data from the study are expected in the third quarter of 2019. 

Zynerba also said it initiated a study for Zygel administered to children and adolescents with autism spectrum disorder, and plans to initiate a study for Zygel in DiGeorge syndrome in the second quarter of 2019.

What's Next

Zynerba anticipates that its cash and cash equivalent position is sufficient to fund its operations and capital requirements beyond the expected submission and potential approval of ZYN002 in Fragile X Syndrome patients and into the first quarter of 2021.

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