Zygel Archives - Green Market Report

StaffOctober 6, 2022

Zynerba Pharmaceuticals (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today announced that the U.S. Patent and Trademark Office has issued Patent No. 11,458,110, titled “Treatment of Fragile X Syndrome With Cannabidiol,” which includes claims directed to methods of treating Fragile X syndrome with cannabidiol.

This new patent, which expires in 2038, is part of an expanding international intellectual property portfolio covering Zynerba’s transdermal cannabidiol product candidate, Zygel. There are currently four corresponding U.S. patents and one corresponding EU patent related to methods of treating Fragile X syndrome. Last year Green Market Report reported that Zynerba
published the results from its open-label Phase 2 BELIEVE (Open-Label Study to Assess the Safety and Efficacy of Zygel (ZYN002) Administered as a Transdermal Gel to Children and Adolescents with Developmental and Epileptic Encephalopathy) study in the Journal of the American Medical Association (JAMA) Network Open.

The study demonstrated a 58% median monthly reduction in seizures at month 5, and a 43.5% reduction over the 6.5 month study period (the primary efficacy endpoint). In addition, the parents/caregivers noted improvements in social or interpersonal engagement and irritability (77%); alertness, energy, and sleep (53%); and cognition or concentration (47%).

48 patients with a mean age of 10.5 years were enrolled in BELIEVE and included in the safety analysis. 60% had at least one treatment-related adverse event (AE) over the 6.5 month trial period and 96% of these AE’s were mild or moderate. During the treatment period, 10 patients (21%) reported serious adverse events (SAEs). Two SAEs were considered to be possible treatment-related: nonconvulsive status epilepticus and lower respiratory tract infection, in separate patients. All SAEs were resolved, and none resulted in an alteration of the study medication. The study warned that there was no control group and so it is impossible to know how much was due to the placebo effect and the desire for cannabis products to work.

Adam JacksonJuly 21, 2022

Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) struck an equity purchase deal on Thursday for up to $20 million with Chicago-based firm Lincoln Park Capital Fund (LPC).

Lincoln Park Capital is expected to provide financial flexibility and is aligned with Zynerba’s long-term strategy for value creation, the company said

“We are excited to enter into this transaction with Lincoln Park Capital and believe that this agreement provides us with another opportunity to access capital in an efficient manner,” said Zynerba CFO and VP Jim Fickenscher. “The financial flexibility provided by this agreement will further support our clinical development efforts with Zygel in Fragile X syndrome and 22q11.2 deletion syndrome.”

Zynerba said it plans to use any net proceeds from the sale of its common stock to LPC for working capital and general corporate purposes, including research and development expenses and capital expenditures.

Under the terms of the agreement, Zynerba will have the right in its sole discretion, but not obligation, to sell to LPC up to $20 million worth of shares of its common stock over the 36-month term of the agreement. Additionally, Zynerba controls the timing and amount of any future sales of its shares of common stock, and LPC is obligated to make purchases in accordance with the terms of the purchase agreement, subject to various limitations including those under the Nasdaq listing rules.

Any common stock that is sold by Zynerba will occur at a purchase price that is based on the market prices prevailing at the time of each sale to LPC. There is no upper limit to the price per share that LPC may pay for future stock issuances under the purchase agreement, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Zynerba’s common stock. No warrants are being issued in this transaction and the purchase agreement does not contain any rights of first refusal, participation rights, penalties, or liquidated damages provisions in favor of any party. Zynerba may terminate the purchase agreement at any time, at its sole discretion, without any cost or penalty, the release said.

Outlook

Zynerba said it believes its $69.7 million of cash and cash equivalents as of March 31, 2022, are sufficient to fund planned operations and capital requirements through the end of 2023 or into early 2024, after the expected availability of top-line results from its confirmatory Pivotal Phase 3 RECONNECT trial of Zygel in patients with Fragile X syndrome.