Manufacturer of transdermal cannabinoid therapies for neuropsychiatric disorders, Zynerba Pharmaceuticals, Inc. Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) reported Tuesday financial results for the fourth quarter and full year ended December 31, 2021.
“In 2022, we look to build on last year’s progress as we continue to enroll patients in our confirmatory pivotal Phase 3 trial in Fragile X syndrome, initiate a Phase 3 program in autism spectrum disorder and report topline results in our Phase 2 trial in 22q11.2 deletion syndrome,” Armando Anido, chairman and chief executive officer of Zynerba stated. “We are committed to achieving our goal of bringing the first pharmaceutical product indicated for the treatment of behavioral symptoms of Fragile X syndrome to market, as well as advancing Zygel in other rare and near rare neuropsychiatric indications.”
Q4 And Full Year 2021 Financial Highlights
- Research and development expenses were $21.4 million for full year 2021, including stock-based compensation of $2.8 million.
- General and administrative expenses were $15.3 million for full year 2021, including stock-based compensation of $3.0 million.
- Research and development expenses were $5.0 million for the fourth quarter of 2021, including stock-based compensation of $0.4 million.
- General and administrative expenses were $3.8 million in the fourth quarter of 2021, including stock-based compensation expense of $0.7 million.
- The net loss for the fourth quarter of 2021 was $8.82 million, with basic and diluted loss per share of $(0.22), comapred to net loss of $9.62 million, and loss per share of $0.33 in the same period of 2020.
- The net loss for the full year 2021 was $37.3 million, with basic and diluted net loss per share of $0.95, versus a net loss of $51.34 million for the full year 2020.
- As of December 31, 2021, cash and cash equivalents were $67.8 million, compared to $59.2 million as of December 31, 2020.
Operational Highlights And Pipeline Update
- In February 2022, the European Commission granted orphan drug designation to cannabidiol, the active ingredient in Zygel, for the treatment of Fragile X Syndrome (FXS). The company continues to expect topline results from RECONNECT, a confirmatory pivotal Phase 3 trial of Zygel in patients with FXS, in the second half of 2023. Zynerba believes that the results from RECONNECT, if positive, will be sufficient to support the submission of a New Drug Application (NDA) for Zygel in patients with FXS.
- In February 2022, the company announced completion of enrollment for the 14-week open-label Phase 2 INSPIRE trial in children and adolescents with genetically confirmed 22q. The company continues to expect topline data from INSPIRE mid-year 2022. A total of 20 patients have been enrolled in the INSPIRE trial. Zynerba plans to move forward in 22q as an orphan indication pending results from the INSPIRE trial, and subsequent discussion with the FDA on the regulatory path forward. The company has previously received orphan drug designation for Zygel in 22q from the FDA.
- The company expects to initiate the first of two Phase 3 trials in patients with ASD in the second half of 2022. It is finalizing the Phase 3 study protocol and will submit an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) prior to commencing the pivotal program.
