Australian-based Zynerba Pharmaceuticals Inc. (ZYNE) delivered second-quarter results and updates on the company’s drugs including its CBD (cannabidiol) gel. The general and administrative expenses for Zynerba during the second quarter of 2019 were $3.3 million, including stock-based compensation expense of $0.8 million. The net loss for the second quarter of 2019 was $11.1 million with a basic and diluted net loss per share of $(0.50).
The company announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 10,314,792 titled “Treatment of Autism Spectrum Disorder with Cannabidiol” which includes claims directed to methods of treating autism spectrum disorder by administering a therapeutically effective amount of synthetic cannabidiol. This new patent expires in 2038 and is part of an expanding intellectual property portfolio covering Zygel.
“The past few months have been very productive for our team,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We initiated new studies in autism spectrum disorder and 22q11.2 deletion syndrome, obtained Fast Track Designation for Zygel™ in FXS, enhanced our senior management team with two excellent additions in Medical and Regulatory, received an important new patent for CBD, and were added to the Russell 2000® and 3000®indices. We also extended our cash runway into the second half of 2021 through the addition of $27.0 million in cash from our ATM in the second quarter and a positive decision from the Australian government that will provide us access to an incremental $7.0 to $9.0 million in research and development cash credits. This all sets the stage for the next 12 months to be potentially transformational as we report out on our FXS pivotal trial, and our Phase 2 trials in DEE, ASD and 22q.”
The company also noted that it was added as a member of the U.S. all-cap Russell 3000 and small-cap Russell 2000 Indexes at the conclusion of the 2019 Russell indexes annual reconstitution at the open of the U.S. markets on July 1, 2019
Anido added, “Regarding the CONNECT-FX study, we believe that pivotal data will now be available in the first half of 2020. We are thrilled with the interest in this study by families who have children with Fragile X syndrome, our investigators, and our advocacy partners. The study design includes specific entrance criteria that have resulted in a higher than predicted screen failure rate. Importantly, these entrance criteria have resulted in an enrolled population with more severe behavioral symptoms than the FAB-C study population. We believe this will enhance the study’s ability to demonstrate a strong signal of activity and minimize response variability.”
Zynerba’s cash and cash equivalent position as of June 30, 2019, was $88.7 million. Management said that it believes that the cash and cash equivalent position including proceeds anticipated from the Australian AOF is enough 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.