Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) posted first-quarter earnings Wednesday that showed it had raised its cash reserves as it heads into key trials and expects top-line data from four neuropsychiatric disorder trials with the company’s lead development candidate, Zygel.
Significantly, the company revealed that as of March 31, it has cash and cash equivalents of $68.3 million, compared to $59.8 million on December 31, 2018. Included in this cash pile is $18.1 million in net proceeds from the sale of about 3.4 miilion shares at $5.44 per during the first quarter to boost R&D spend.
Management said the company's $68.3 million war chest is “sufficient to fund operations and capital requirements beyond the expected New Drug Application submission and potential approval in Fragile X syndrome and into the first quarter of 2021.”
“We are entering a transformational period for Zynerba during which we expect top-line data from four neuropsychiatric disorder trials with Zygel, our patent protected CBD gel,” said Zynerba Pharmaceuticals CEO Armando Anido.
For the first quarter, the company reported a net loss of $9.1 million, or $0.47 per share. The results beat Wall Street expectations, with analysts surveyed by Zacks Investment Research calling for a loss of $0.48 per share.
Fast track designation
The US Food and Drug Administration granted Fast Track designation to the company’s lead development candidate, Zygel. The Devon, Pennsylvania, company is on track to report top-line results from tests of its Zygel, a CBD gel treatment for children and adolescents with Fragile X syndrome, the most common form of inherited learning disability and autism spectrum disorder.
“We’ve made great progress with Zygel, which was recently designated as a Fast Track development program by the FDA for treating behavioral symptoms of Fragile X Syndrome,” said Anido. “Over the next 14 months, we expect to announce data from the CONNECT-FX pivotal trial in Fragile X, our Phase 2 BELIEVE 1 trial in developmental and epileptic encephalopathies, our Phase 2 BRIGHT trial in Autism Spectrum Disorder, and the Phase 2 trial in 22q11.2 Deletion Syndrome that we intend to initiate this quarter.”
The CEO expects the company’s “cash position will take us through all of these data readouts, through our anticipated NDA submission and potential approval for Zygel in FXS, and into the first quarter of 2021.”
Zygel was previously referred to as ZYN002, a synthetic cannabidiol, which is a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. The company recently selected Zygel as the new brand name for ZYN002.
Enrollment is progressing in a pivotal CONNECT-FX Trial of Zygel in Fragile X syndrome, said the company in a statement with “data expected in the second half of 2019.”
Fragile X is also the most commonly known single gene cause of autism spectrum disorder.
Zynerba Pharmaceutical’s principal line of business are cannabinoid treatments delivered via the skin to treat neurological and psychiatric disorders.
Contact Uttara Choudhury at [email protected]