Zynerba Pharmaceuticals, Inc. (ZYNE) reported its earnings for the first quarter ending March 31, 2020, with no revenue and a net loss of $12.3 million and a net loss per share of $(0.53). Despite COVID-19 disruptions, the company said that it expects timelines for delivery of top-line results from all of its ongoing trials will not be impacted.
“The past few months have been historic due to the outbreak of COVID-19, and we applaud everyone on the front line of this global pandemic, including healthcare workers, first responders, humanitarians, and our industry colleagues who are dedicated to the rapid development of treatments and vaccines,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “In response to the pandemic, Zynerba implemented important initiatives that we believe protect the safety of patients, clinical investigators and their staff, and our Zynerba employees and should allow us to conclude all three of our ongoing clinical trials and report top-line results within our stated timelines.”
Second Quarter Events
While the first quarter kept chugging along, Zynerba’s second quarter looks to be shaping up as a big one for news. If Zynerba gets positive results from its Fragile X study, the company said it 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. Zynerba also said it expects to submit its NDA for Zygel in FXS to the FDA in the second half of 2020, with potential approval by mid-year 2021.
Zynerba is also expecting top-line results from its trail for Zygel in treating children with autism in the second quarter. The U.S. Patent and Trademark Office has issued U.S. Patent No. 10,568,848, titled “Treatment of Autism with Cannabidiol” which includes claims directed to methods of treating ASD by transdermally administering, via a gel or cream, a therapeutically effective amount of purified CBD. The patent expires in 2038.
Zynerba said that it anticipates that it will pursue an indication that includes the syndromes and encephalopathies in the DEE category that presents with focal impaired-awareness seizures and expects to disclose the outcome of the interactions with the FDA in the second quarter of 2020.
Enough Cash Cushion
The company believes that its 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 company reported that it has cash and cash equivalents of $60.6 million, compared to $70.1 million as of December 31, 2019. Research and development expenses for the first quarter of 2020 were $6.9 million, including stock-based compensation of $0.5 million. General and administrative expenses for the first quarter of 2020 were $3.9 million, including stock-based compensation expense of $0.8 million.