See feature article below: Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE)
About Broad Street Alerts:
Big opportunities in Small Cap’s
Broad Street Alerts recent profiles and track record, 568% in verifiable potential gains for our members on 2 recent small cap alerts alone!
May 9th, 2016-(NYSE-MKT: MGT) opened at .64/share and hit over $4.15/share within 8 days for potential gains of 548% for our members.
May 23rd, 2016 (NYSE-MKT: XXII) opened at $.78/share and hit $.94/share within 2 days for potential gains of 20% for our members.
***Get our small cap profiles, special situation and watch alerts in real time. We are now offering our VIP SMS/text alert service for free, simply text the word “Alerts” to the phone number 25827 from your cell phone.
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
DISCLAIMER
Broadstreetalerts.com is a wholly owned subsidiary of Small Cap Specialists LLC, herein referred to as SCS LLC.
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: SCS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold SCS LLC, its operators owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. SCS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and SCS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead SCS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D. SCS LLC is compliant with the Can Spam Act of 2003. SCS LLC does not offer such advice or analysis, and SCS LLC further urges you to consult your own independent tax, business, financial and investment advisors. SCS LLC has been compensated twenty thousand dollars cash via bank wire by star media llc for a two day investor relations campaign of STEM. SCS LLC does not hold any positions in STEM. SCS LLC has previously been compensated twenty thousand dollars cash via bank wire by DF Media for the mention of MGT. We do not hold any positions in MGT. Investing in micro-cap and growth securities is highly speculative and carries and extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled. We have not been compensated nor do we own positions in the company/companies that are in the featured article.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur. Understand there is no guarantee past performance will be indicative of future results.
In preparing this publication, SCS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, SCS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. SCS LLC is not responsible for any claims made by the companies advertised herein, nor is SCS LLC responsible for any other promotional firm, its program or its structure.
Please Note: We do NOT accept free trading or restricted securities as payment for our services.
SCS LLC is not affiliated with any exchange, electronic quotation system, the Securities Exchange Commission or FINRA. SCS LLC is not a Broker/Dealer and does not engage in high frequency trading.
Stock market
Hot small cap stocks
small cap stock picks
Biotech stocks
FDA approval stocks
FDA calendar
Trade stocks
Become a day trader
Day trade stocks for a living
PDUFA date set
micro cap stocks
Best stocks 2016
Hottest small cap stocks
Best stock picks
Who to follow for stock picks
Apple news stock picks
Stock picks on apple news
