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Zynerba Pharmaceuticals Announces Poster Presentations at the 55th Gatlinburg Conference

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Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced its participation in the 55th Gatlinburg Conference, scheduled for April 10-13, 2023, in Kansas City, Mo. The company will present two posters: one on the long-term safety and sustained efficacy of ZYN002 in children with Fragile X Syndrome on April 12, and another on an open-label study of ZYN002 for children with 22q11.2 deletion syndrome on April 13. Zygel, Zynerba's transdermal cannabinoid gel, aims to treat behavioral symptoms associated with these conditions and has received Fast Track designation from the FDA.

Positive
  • Zynerba's Zygel has received orphan drug designation for treating Fragile X Syndrome and 22q11.2 deletion syndrome from the FDA and European Commission.
  • Zygel has been designated a Fast Track development program by the FDA for behavioral symptoms of Fragile X syndrome.
  • The presentation of two posters at a significant conference highlights ongoing research and development efforts.
Negative
  • None.

DEVON, Pa., April 05, 2023 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today announced the presentation of two posters at the 55th Gatlinburg Conference, being held April 10-13, 2023, in Kansas City, Mo. Copies of the posters will be made available on the Zynerba corporate website following the presentation at www.zynerba.com/publications.

Wednesday Poster Presentation Details

Title: Long-term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017)
Date: Wednesday, April 12, 2023
Time: 10:00 a.m. - 11:30 a.m. CT
Location: Westin Crown Center, Kansas City, Mo.

Thursday Poster Presentation Details 

Title: An Open-Label, Tolerability and Efficacy Study of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE)
Date: Thursday, April 13, 2023
Time: 9:00 a.m. - 10:00 a.m. CT
Location: Westin Crown Center, Kansas City, Mo.

About Zygel

Zygel is the first and only pharmaceutically-manufactured cannabidiol formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled drug delivery into the bloodstream transdermally (i.e. through the skin). Recent studies suggest that cannabidiol may modulate the endocannabinoid system and improve certain behavioral symptoms associated with neuropsychiatric conditions. Zygel is an investigational drug product in development for the potential treatment of behavioral symptoms associated with Fragile X syndrome (FXS) and 22q11.2 deletion syndrome (22q). The Company has received orphan drug designation for cannabidiol, the active ingredient in Zygel, from the FDA and the European Commission in the treatment of FXS and the treatment of 22q. Additionally, Zygel has been designated a Fast Track development program for treatment of behavioral symptoms of FXS.

About Zynerba Pharmaceuticals, Inc.

Zynerba Pharmaceuticals is the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X syndrome and 22q11.2 deletion syndrome. Learn more at www.zynerba.com and follow us on Twitter at @ZynerbaPharma.  

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, incentive and other tax credit eligibility, collectability and timing, and availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its clinical development programs; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; clinical results for the Company’s product candidates may not be replicated or continue to occur in additional trials and may not otherwise support further development in a specified indication or at all; actions or advice of the U.S. Food and Drug Administration, the European Medicines Agency and other foreign regulatory agencies may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company’s ability to obtain and maintain regulatory approval for its product candidates, and the labeling under any such approval; the Company’s reliance on third parties to assist in conducting pre-clinical and clinical trials for its product candidates; delays, interruptions or failures in the manufacture and supply of the Company’s product candidates the Company’s ability to commercialize its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates; the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates; the extent to which health epidemics and other outbreaks of communicable diseases, including COVID-19, could disrupt our operations or adversely affect our business and financial conditions; and the extent to which inflation or global instability, including political instability, may disrupt our business operations or our financial condition. This list is not exhaustive and these and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Zynerba Contacts

Peter Vozzo
ICR Westwicke
Office: 443.213.0505
Cell: 443.377.4767
Peter.Vozzo@Westwicke.com


FAQ

What is Zynerba Pharmaceuticals presenting at the Gatlinburg Conference 2023?

Zynerba Pharmaceuticals will present two posters on April 12 and 13, 2023, focusing on ZYN002 for Fragile X Syndrome and 22q11.2 deletion syndrome.

When is Zynerba's poster on ZYN002 for Fragile X Syndrome scheduled?

The poster on the long-term safety and efficacy of ZYN002 in children with Fragile X Syndrome is scheduled for April 12, 2023.

What is Zygel and its significance?

Zygel is a transdermal cannabinoid gel designed to treat behavioral symptoms in patients with Fragile X syndrome and 22q11.2 deletion syndrome.

What designations has Zygel received for its treatment programs?

Zygel has received orphan drug designation and Fast Track designation from the FDA for its treatment programs.

Where can I find copies of Zynerba's conference posters?

Copies of the posters will be available on Zynerba Pharmaceuticals' corporate website after the presentations.

Zynerba Pharmaceuticals, Inc.

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