Debra BorchardtBiotech company Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) reported its fourth-quarter and full-year results for the period ending in December. The company has no revenues to report at this time. The research and development expenses were $5.6 million for the fourth quarter of 2020, including stock-based compensation of $0.6 million. General and administrative expenses were $4.6 million in the fourth quarter of 2020, including stock-based compensation expense of $0.6 million. The net loss for the fourth quarter of 2020 was $9.6 million with a basic and diluted loss per share of $(0.33). Zynerba beat estimates which were ($0.38).
For 2020, research and development expenses were $35.7 million, including stock-based compensation of $2.2 million. General and administrative expenses were $16.4 million for full-year 2020, including stock-based compensation expense of $3.0 million. The net loss for the full year 2020 was $51.3 million with basic and diluted net loss per share of $(1.90).
“We expect to make significant progress in 2021 on all four indications for which we are developing Zygel, including initiating a pivotal trial in patients with Fragile X syndrome who have a highly methylated FMR1 gene to confirm the positive results in this population of responders in the CONNECT-FX trial,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “Screening in the INSPIRE trial of patients with 22q11.2 deletion syndrome has resumed now that COVID-19 restrictions in Australia have begun to ease. Once enrollment is complete we will update our expectation on when we will see topline results for this trial.”
As of December 31, 2020, cash and cash equivalents were $59.2 million, compared to $70.1 million as of December 31, 2019. Management believes that cash and cash equivalents, including the $42.2 million in net proceeds from issuances between January 1 and February 9, 2021, under the 2019 Sales Agreement, are sufficient to fund operations and capital requirements well into the first half of 2024.
Net losses for the years 2019 and 2018 were approximately $32.9 million and $39.9 million, respectively. As of December 31, 2020, the company had an accumulated deficit of $202.2 million.
Zygel in Fragile X Syndrome (FXS)
The company’s most promising indication is for Zynerba. In the earnings release, the company said that it expects to initiate a single double-blind, placebo-controlled pivotal trial before the end of 2021 in patients with FXS who have a highly methylated FMR1 gene to confirm the positive results observed in this population of responders in the CONNECT-FX trial. The Company believes that positive results from this confirmatory pivotal trial will be sufficient to support the submission of a New Drug Application for Zygel in FXS. Zynerba said it will review the trial design and protocol for the new confirmatory pivotal trial through a Type C meeting with the U.S. Food and Drug Administration (FDA) in the first half of 2021.
