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Zynerba ends 3Q with robust $55.9M cash runway to advance its Zygel CBD Gel for Fragile X Syndrome

Published: 09:39 14 Nov 2022 EST

Zynerba Pharmaceuticals Inc - ends 3Q with robust $55.9M cash runway to advance its Zygel CBD Gel for Fragile X Syndrome
“With a cash runway into the 1Q 2024, we remain well-positioned on achieving our goal of bringing Zygel to market as the first Food and Drug Administration approved treatment option for the significant unmet medical need that affects FXS patients,” said Zynerba CEO Armando Anido

Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE), which works on innovative pharmaceutically produced transdermal cannabinoid therapies for neuropsychiatric disorders, posted results for the third quarter that revealed ample cash on hand, giving the company scope to fund pivotal trials of its flagship product Zygel (ZYN002).

As of September 30, 2022, the Devon, Pennsylvania-based company had cash and equivalents of $55.9 million, compared to $67.8 million at the end of December 2021.

During the quarter, the company sold and issued 2.58 million shares of its common stock under a 2021 sales agreement in the open market resulting in gross proceeds of $3.2 million and net proceeds of $3 million, after deducting commissions and offering expenses.

READ: Zynerba Pharmaceuticals gets another US Patent for its transdermal cannabidiol product, Zygel

Management believes the company's $55.9 million war chest will be “sufficient” to fund operations and capital requirements into the first quarter of 2024.

The company's flagship Zygel will be in focus for the rest of the year. The product is a patent-protected CBD skin gel, which is being developed to treat a slew of rare neuropsychiatric disorders.

For the quarter, Zynerba reported R&D expenses of $5 million, including stock-based compensation of $0.5 million and admin expenses of $3.5 million. The company’s net loss for the quarter was $8.7 million, or $0.20 per basic and diluted share.

“Enrollment in our confirmatory pivotal Phase 3 RECONNECT trial continues, and we expect topline results in the second half of 2023,” Zynerba CEO Armando Anido said in an earnings statement.

“With a cash runway into the first quarter of 2024, we remain well-positioned on achieving our goal of bringing Zygel to market as the first United States Food and Drug Administration (FDA) approved treatment option for the significant unmet medical need that affects FXS patients and their families,” he added.

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, which causes mild to severe intellectual disability. 

In October this year, the US Patent and Trademark Office issued a patent, which includes claims directed to methods of treating Fragile X syndrome with cannabidiol. The new patent, which expires in 2038, is part of an expanding IP portfolio covering Zygel.

Zygel in 22q11.2 Deletion Syndrome

In addition, based on the positive Phase 2 INSPIRE trial data revealed in June this year, Zynerba requested and has been granted an initial meeting with the US FDA before the end of 2022 to obtain feedback on the Phase 2 data and regulatory pathway for Zygel in patients with 22q, a disorder caused by a missing piece of the 22nd chromosome.

The company said it currently plans to initiate a Phase 3 program in children and adolescents with 22q following topline results from RECONNECT.

Zygel is the first and only patent-protected cannabidiol clear gel, designed to provide controlled drug delivery into the bloodstream through the skin, according to the company. It is a potential goldmine of therapies for Fragile X syndrome and other conditions.

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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