Zynerba Pharmaceuticals Reports First Quarter 2019 Financial Results and Operational Highlights

Zygel in 22q11.2 Deletion Syndrome (22q)

Initiation of Phase 2 Trial in 22q Anticipated Later this Quarter; Data Expected in the First Half of 2020

Zynerba has finalized the protocol to evaluate the efficacy and safety of Zygel in approximately 20 children and adolescents (ages six through 17) with genetically-confirmed 22q. The Company expects to initiate this study during the second quarter of 2019, and to present topline data in the first half of 2020.

Corporate

Dr. Thomas Harrison resigned from the Company’s Board of Directors to focus on his role with Merida Capital Partners as Senior Operating Partner. Dr. Harrison served on Zynerba’s Board of Directors since April 2015.

“On behalf of Zynerba’s Board of Directors and management team, I would like to thank Tom for his outstanding service and leadership during his term as a member of our board,” continued Mr. Anido. “His expertise and counsel have been invaluable to Zynerba and we wish him well in his new endeavor.”

First Quarter 2019 Financial Results

As of March 31, 2019, cash and cash equivalents were $68.3 million, compared to $59.8 million as of December 31, 2018. Included in this cash and cash equivalents position is $18.1 million in net proceeds from the 3,439,523 shares sold and issued at a weighted average selling price of $5.44 per share during the first quarter of 2019 under an Open Market Sales Agreement, or “at-the-market” (ATM) offering program, with Jefferies LLC. Research and development expenses for the first quarter of 2019 were $6.3 million, including stock-based compensation of $0.7 million. General and administrative expenses for the first quarter of 2019 were $3.2 million, including stock-based compensation expense of $0.8 million. The net loss for the first quarter of 2019 was $9.1 million with basic and diluted net loss per share of $(0.47).

Financial Outlook

The Company’s cash and cash equivalent position as of March 31, 2019 was $68.3 million. Management believes that the cash and cash equivalent position is sufficient to fund operations and capital requirements beyond the expected NDA submission and potential approval in FXS and into the first quarter of 2021.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals is the leader in 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 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; and the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates. 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.

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