Debra Borchardt
Cannabis biotech company Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) reported financial results for the second quarter ended June 30, 2021, and provided an overview of recent operational highlights and a pipeline update. Zynerba’s research and development expenses were $5.5 million for the second quarter of 2021, including stock-based compensation of $1.0 million. General and administrative expenses were $4.4 million in the second quarter of 2021, including stock-based compensation expenses of $0.9 million. The net loss for the second quarter of 2021 was $10.0 million, with a basic and diluted loss per share of $(0.25).
This missed analyst estimates from Yahoo Finance, who had expected a loss of $0.24. Seven analysts are covering the company with three buy ratings, three holds, and one strong buy. the average price target is $7.63 and the stock was lately selling at $4.45.
As of June 30, 2021, cash and cash equivalents were $85.8 million, compared to $59.2 million as of December 31, 2020. Management believes that the company’s cash and cash equivalents as of June 30, 2021, are sufficient to fund operations and capital requirements well into the first half of 2024.
“We continue to make progress across our portfolio, particularly in FXS in which our confirmatory pivotal Phase 3 trial, RECONNECT, is expected to start in the third quarter of 2021,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “Following a positive meeting with the FDA on our development program in autism spectrum disorder (ASD), we are evaluating and prioritizing our development options for ASD, 22q and developmental and epileptic encephalopathies and we expect to provide guidance on the path forward in each of these indications by the end of 2021.”
Zynerba said in a statement that 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 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.
In the first half of 2021, Zynerba discussed data supporting the potential efficacy of Zygel for treating autism (ASD), including the results of Phase 2 BRIGHT trial, with the U.S. Food and Drug Administration (FDA) to determine the regulatory path forward. The guidance from the FDA included an agreement on utilizing the irritability subscale of the Aberrant Behavior Checklist – Community (ABC-C) as the primary endpoint to support an indication for the treatment of irritability in ASD. This is the same primary endpoint utilized in the previously completed BRIGHT open-label Phase 2 trial.
