29 Apr 21
Zynerba Pharmaceuticals Presents Two Posters at the Society of Biological Psychiatry 2021 Virtual Meeting

DEVON, PA, April 29, 2021 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, is presenting two posters at the Society of Biological Psychiatry (SOBP) 2021 Virtual Meeting. Both posters will be made available on the Zynerba corporate website at the time of their presentations at http://zynerba.com/publications/.

The first poster titled, “Cannabidiol in Fragile X Syndrome (FXS): Proposed Mechanism of Action (MOA) Translates Into Meaningful Clinical Benefits [CONNECT-FX (ZYN2-CL-016)]” describes responder thresholds representing individual patient-level changes that the company believes are indicative of meaningful treatment benefit for the ABC-CFXS social avoidance, irritability, and socially unresponsive/lethargic subscales. The authors concluded:

  • Responder thresholds for meaningful within-patient behavioral change on key domains of the ABC-CFXS were determined using anchor-based methods based upon FDA guidance for caregiver-reported outcomes
  • The responder thresholds for meaningful within-patient behavioral change in CONNECT-FX corresponded to the following reductions
    • 3 or more points on the ABC-CFXS Social Avoidance subscale
    • 9 or more points on the ABC-CFXS Irritability subscale
    • 5 or more points on the ABC-CFXS Socially Unresponsive/Lethargic subscale
  • These thresholds serve as a basis for evaluating clinically meaningful treatment effects at the individual patient level in clinical trials of children and adolescents with FXS as demonstrated for Zygel (ZYN2) in CONNECT-FX
  • Zygel provided meaningful improvements in behavioral symptoms of FXS in patients with ≥90% methylation of the FMR1 gene.

The poster, with submission ID #3010113, will be presented today in Poster Session I beginning at 12:15 p.m. CT (1:15 p.m. ET).

“We believe these data demonstrate the ABC-CFXS subscales capture behaviors that are impactful and meaningful in clinical trials of children with FXS,” said Joseph M. Palumbo, M.D., LFAPA, MACPsych, Chief Medical Officer of Zynerba. “Therefore, we remain confident that these subscales are fit for purpose for measuring clinical trial endpoints in FXS.”

The second poster titled, “A Pivotal Study of ZYN002 Cannabidiol (CBD) Transdermal Gel in Children and Adolescents With Fragile X Syndrome [CONNECT-FX (ZYN2-CL-016)]” will be presented on April 30, 2021 and focuses on the findings in the CONNECT-FX study for the 80% of randomized patients whose FMR1 genes were highly methylated. This poster, with submission ID #3010130 will be presented tomorrow in Poster Session II beginning at 12:00 p.m. CT (1:00 p.m. ET).

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals is the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X syndrome, autism spectrum disorder, 22q11.2 deletion syndrome, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies. 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 and 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 timing and outcome of current and future legal proceedings; and 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. 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.

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