Cannabis pharmaceutical company Zynerba Pharmaceuticals, Inc. (ZYNE) stock was moving higher in premarket trading after the company reported financial results for the fourth quarter and full-year ending December 31, 2019.
The company had no revenue for 2019 as it is currently developing drugs. The net loss for the fourth quarter of 2019 was $10.7 million with a basic and diluted net loss per share of $(0.46). The net loss for the full year of 2019 was $32.9 million with a basic and diluted net loss per share of $(1.50).
The company said it has $70.1 million in cash. Zynerba believes that the cash runway is sufficient to fund operations and capital requirements beyond the expected NDA submission and potential approval of Zygel in FXS and into the second half of 2021.
“The fourth quarter of 2019 capped off a year of strong execution by Zynerba,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “With a number of shots-on-goal in our clinical pipeline, each with near term milestones, our outlook is promising for the remainder of 2020 and beyond. We are positioned for major news events throughout this year and next, including the topline results from our pivotal CONNECT-FX trial of Zygel™ in patients with Fragile X syndrome which are expected late next quarter.”
Enrollment is complete with 212 patients randomized into CONNECT-FX, a pivotal, multinational, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Zygel in treating common behavioral symptoms of FXS.
Zynerba said it expects to report topline results late in the second quarter of 2020. If the results are positive, Zynerba intends to request a meeting with the FDA to determine the acceptability of the data as a basis for a New Drug Application (NDA) and to seek advice on the preparation of the marketing authorization. The company expects to submit its NDA for Zygel in FXS to the U.S. Food and Drug Administration (FDA) in the second half of 2020, with potential approval by mid-year 2021.
Enrollment is complete in Phase 2 BRIGHT trial assessing the safety, tolerability and efficacy of Zygel for the treatment of pediatric and adolescent patients with ASD. The 14-week trial is evaluating the efficacy and safety of Zygel in 37 children and adolescents (ages four through 17) with moderate-to-severe ASD. The mean age of the patients is 9.2 years old and 92% of the enrolled patients are male. Zynerba expects to report topline results from this study in the second quarter of 2020.