See feature article below: Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE)
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Report For: Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE)
ZYNE shares are up 13% today at $8.78 with slightly higher than average trading volume. Zynerba is developing therapeutic candidates based on proprietary transdermal technologies that, if successfully developed, may allow sustained, consistent and controlled delivery of therapeutic levels of two cannabinoids: cannabidiol (CBD), a non-psychoactive cannabinoid, and THC.
About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (ZYNE) is a specialty pharmaceutical company focused on developing and commercializing proprietary next-generation synthetic cannabinoid therapeutics formulated for transdermal delivery. Zynerba is developing therapeutic candidates based on proprietary transdermal technologies that, if successfully developed, may allow sustained, consistent and controlled delivery of therapeutic levels of two cannabinoids: cannabidiol (CBD), a non-psychoactive cannabinoid, and THC. Transdermal delivery has the potential to reduce adverse effects associated with oral dosing. ZYN002, the Company’s CBD gel, is the first and only synthetic CBD formulated as a patent protected permeation-enhanced gel and is being studied in refractory epilepsy, FXS and osteoarthritis. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC in a transdermal patch to deliver THC through the skin and into the bloodstream. ZYN001 will be studied in fibromyalgia and peripheral neuropathic pain.
DEVON, Pa., May 12, 2016 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (ZYNE), a specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today reported financial results for the quarter ended March 31, 2016, and provided an overview of recent operational highlights.
“We continue to make rapid progress in our ZYN002 cannabidiol (CBD) gel clinical development program with positive initial results reported in a Phase 1 single rising dose trial, the initiation of a second Phase 1 trial in healthy volunteers and patients with epilepsy, and a grant of orphan drug designation from the US Food and Drug Administration for the treatment of Fragile X syndrome,” said Armando Anido, Chairman and CEO of Zynerba Pharmaceuticals.
“Further, important in vitro data were published in Cannabis and Cannabinoid Research demonstrating that orally administered CBD is converted into psychoactive cannabinoids when exposed to gastric fluid. Zynerba’s transdermal delivery of CBD bypasses the acidic environment of the stomach and thus, avoids the potential for formation of psychoactive cannabinoids. These data support the Company’s strategy of pursuing a transdermal delivery and we are on pace to initiate Phase 2 clinical trials in three indications in the second half of this year.”
Highlights from the First Quarter 2016 and Recent Developments
Reported Positive Initial Results from a Phase 1 Single Rising Dose Trial and Initiated a Phase 1 Multiple Rising Dose Trial of ZYN002 CBD Gel: In January 2016, Zynerba reported positive initial safety results from its Phase 1 single rising dose clinical trial of its ZYN002 CBD gel. Initial results demonstrated that ZYN002 was safe and well tolerated at all four dose levels. The Company also announced the initiation of a Phase 1 multiple rising dose trial to evaluate the pharmacokinetic (PK) profile and tolerability of ZYN002 in 24 healthy volunteers, followed by 12 patients with epilepsy.
ZYN002 Granted Orphan Drug Designation for Fragile X Syndrome: In February 2016, the U.S. Food and Drug Administration granted orphan-drug designation to ZYN002 CBD gel, for the treatment of Fragile X syndrome (FXS). FXS is a genetic condition that causes intellectual disability, anxiety disorders, behavioral and learning challenges and various physical characteristics. In mouse knockout models for FXS, symptoms are improved when endocannabinoid levels are increased. There is also anecdotal evidence that high levels of CBD oil from plants have proven effective at improving socialization and language skills in children.
Data Published Demonstrating the Degradation of Orally Administered Cannabidiol to Psychoactive Cannabinoids when Exposed to Simulated Gastric Fluid: In April 2016, the Company announced publication online in Cannabis and Cannabinoid Research of in vitro data demonstrating that the acidic pH conditions provided in simulated gastric fluid converts CBD into psychoactive components Δ9–THC, Δ8–THC and other psychoactive cannabinoids. These data suggest that the oral route of administration may increase the potential for psychoactive adverse effects due to the conversion of CBD to THC following oral dosing of CBD- medications. Zynerba’s transdermal formulation of CBD, ZYN002, is an alternative delivery method that bypasses the acidic environment of the stomach and avoids the potential for formation of psychoactive cannabinoids.
Anticipated 2016 Milestones
ZYN002, synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery
By the end of the first half of 2016, Zynerba expects to report final results from its ongoing Phase 1 single rising dose clinical trial, including results from 12 patients with epilepsy.
By the end of the first half of 2016, Zynerba expects to report results from its second ongoing Phase 1 multiple rising dose clinical trial.
Pending the results of the Phase 1 trials, Zynerba plans to initiate Phase 2 trials in refractory epilepsy, osteoarthritis (OA), and FXS in the second half of 2016.
ZYN001, pro-drug of THC that enables transdermal delivery via patch
In the second half of 2016 Zynerba expects to initiate Phase 1 studies to evaluate the PK profile and tolerability of ZYN001 in healthy volunteers and patients with fibromyalgia.
First Quarter 2016 Financial Results
As of March 31, 2016, cash and cash equivalents were $36.8 million, compared to $41.5 million as of December 31, 2015.
Research and development expenses for the first quarter of 2016 were $2.6 million, including stock-based compensation of $0.3 million. General and administrative expenses for the first quarter of 2016 were $1.7 million, including stock-based compensation expense of $0.5 million. Net loss for the first quarter of 2016 was $4.3 million with basic and diluted net loss per share of $0.49. Adjusted EBITDA for the period, which excludes stock-based compensation and foreign currency loss, was $(3.5) million, or $0.39 per basic and diluted net loss per share.
Financial Outlook
Based on current operating plans, the Company expects that its existing cash and cash equivalents will fund its research and development programs and operations through 2017, which will include Phase 2 data readout for the five indications of ZYN002 and ZYN001.
Source – Company Press Release
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