Zynerba's Shares Jump on CBD Zygel Trial Plans, Company Reports Cash Until 2024
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) disclosed Wednesday its first-quarter net loss of $8.0 million or a loss of 20 cents per share, compared to $12.34 million in the same period of 2020 or a loss of 53 cents per share.
First Quarter Highlights
Cannabinoid-focused pharmaceutical company does not have revenue in the period of drugs development.
It also reported research and development expenses of $4.6 million, counting stock-based compensation of $600,000. It had general and administrative expenses of $3.3 million in the first quarter, with a stock-based compensation cost of $600,000.
Back in August of 2019, Zynerba signed a controlled equity offering SM sales agreement with Cantor Fitzgerald & Co., Canaccord Genuity, LLC, H.C. Wainwright & Co. LLC and Ladenburg Thalmann & Co. Inc. as sales agents. During the first quarter of 2021, the company issued and sold 10.24 million shares under the agreement in the open market at a price of $4.22 per share, collecting net proceeds of $42.2 million.
At the end of the reporting period, Zynerba held $93.1 million in cash and cash equivalents, which it considers enough to support its activities until the first half of 2024.
“We are committed to delivering on our important milestones in 2021 as we develop Zygel in multiple neuropsychiatric indications, including initiating a confirmatory pivotal Phase 3 trial, RECONNECT, in the third quarter of 2021, after productive dialogue and alignment with the FDA,” Armando Anido, chairman and CEO of Zynerba stated. “With a cash runway that takes us well into the first half of 2024, we believe that we are ideally positioned to continue our efforts to develop the first FDA-approved treatment for patients with Fragile X syndrome.”
New Applications For Zygel
Zynerba plans to launch a Phase 3 trial of Zygel in children and adolescents with fragile X syndrome (FXS) during the third quarter of 2021. Zygel is a pharmaceutically-produced CBD, patent-protected gel for transdermal delivery developed by Zynerba. Fragile X syndrome is a genetic disorder reflected in mild to moderate intellectual disability.
The trial is expected to confirm the positive results previously shown in the CONNECT-FX trial. The company expressed confidence that positive results from the newest trial should be enough to submit a New Drug Application for Zygel in patients with FXS.
Furthermore, the company plans to review with the FDA the data around the potential efficacy of Zygel in treating autism spectrum disorder. It is running a trial that will help complete target syndrome selection in one or more developmental and epileptic encephalopathy syndromes.
Zynerba’s shares were trading 7.43% higher at $4.47 per share at the time of writing.
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