Author: Jennifer Guinan

Devon, PA, November 14, 2016 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today reported financial results for the third quarter ended September 30, 2016 and provided an overview of recent operational highlights.

“The third quarter was marked by significant advancement of our lead development candidate, ZYN002 CBD gel,” said Armando Anido, Chairman and CEO. “We initiated randomization and dosing, and are continuing to enroll patients into the STAR 1 refractory epilepsy clinical trial.  We also initiated the STOP trial, which will evaluate ZYN002 CBD gel in patients with knee pain associated with osteoarthritis. We look forward to initiating a third Phase 2 clinical trial of ZYN002 CBD gel in patients with Fragile X Syndrome by year-end. We expect to report top line results of all three Phase 2 clinical trials in the first half of 2017.”

Highlights from the Third Quarter 2016 & Recent Developments

Began Dosing of First Patients in STAR 1 Clinical Trial for the Treatment of Adult Epilepsy

• In August, Zynerba began dosing patients in STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy), a randomized, multi-center, multi-dose Phase 2 clinical trial that will evaluate 97.5 mg or 195 mg of CBD in ZYN002 4.2% gel or placebo every 12 hours in approximately 180 adult refractory epilepsy patients with focal seizures. The primary endpoint will assess the median percentage change in seizure frequency over the 12-week treatment period versus baseline. Safety and tolerability will also be assessed.

Initiated STAR 2 Open-Label Extension for the Treatment of Adult Epilepsy

• In November, Zynerba initiated an open-label clinical trial in adult epilepsy patients with refractory focal seizures who complete the STAR 1 study. Patients will receive treatment with ZYN002 for up to 52-weeks. The open-label clinical trial is designed to support long-term safety and tolerability of ZYN002 CBD gel.

Launched Phase 2 STOP Clinical Trial for the Treatment of Osteoarthritis (OA)

• In September, Zynerba initiated the STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) trial, a multi-center, placebo-controlled, Phase 2 clinical trial that will evaluate 125 mg or 250 mg of CBD in ZYN002 4.2% gel or placebo twice daily in approximately 300 patients with knee pain due to OA. The primary endpoint is the change from baseline in the weekly mean of the 24-hour average worst pain score.

Updated Progress with ZYN001 pro-drug of THC Patch

• In October, the Company announced that it is working with LTS Lohmann Therapie-Systeme AG, a market leader in transdermal therapeutic solutions, to optimize the formulation of ZYN001 into a state of the art drug-adhesive matrix transdermal patch. ZYN001 is a patent-protected pro-drug of THC being developed for the treatment of fibromyalgia and peripheral neuropathic pain.

Upcoming Events in the Fourth Quarter of 2016

• At the American Society of Epilepsy meeting to be held in Houston, TX, from December 2-6, Zynerba will present two posters highlighting safety and tolerability and cognitive and mood effects for ZYN002.
• Zynerba will host a Clinical Research Day on December 15^th in New York City featuring distinguished experts who will discuss the role of cannabinoid-based treatments in epilepsy, osteoarthritis and Fragile X syndrome.

Upcoming Clinical Milestones

ZYN002 CBD Gel 

• Zynerba plans to initiate a third Phase 2 clinical trial of ZYN002 in patients with Fragile X syndrome (FXS) by year-end 2016.
• Top line results of three Phase 2 clinical trials in refractory epilepsy, OA and FXS are expected in the first half of 2017.

ZYN001 pro-drug of THC Patch

• Zynerba expects to initiate Phase 1 clinical trials to evaluate the pharmacokinetic profile and tolerability of ZYN001 in healthy volunteers in the first half of 2017.
• Phase 2 clinical trials in the treatment of fibromyalgia and peripheral neuropathic pain are planned to begin in the second half of 2017.

Third Quarter 2016 Financial Results

As of September 30, 2016, cash and cash equivalents were $31.8 million, compared to $32.1 million as of June 30, 2016.  In September 2016, the Company entered into an Open Market Sales Agreement with Jefferies LLC pursuant to which, as of November 11, 2016, the Company sold and issued 753,799 shares of its common stock in the open market at a weighted average selling price of $13.38 per share, for net proceeds of $9.5 million, $5.3 million of which were received and included in cash and cash equivalents as of September 30, 2016.  The remaining $4.2 million of net proceeds was received after September 30, 2016 and will be included in the fourth quarter financial statements.

Research and development expenses for the third quarter of 2016 were $4.5 million, including non-cash stock-based compensation of $0.3 million. General and administrative expenses for the third quarter of 2016 were $1.5 million, including non-cash stock-based compensation expense of $0.5 million. Net loss for the third quarter of 2016 was $6.0 million with basic and diluted net loss per share of ($0.67).

Financial Outlook

Management believes that the Company’s available funds, including proceeds from the sale of common stock received through November 11, 2016, are sufficient to develop five Phase 3 ready programs and these resources are sufficient to fund operations and capital requirements into 2018.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage 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 tetrahydrocannabinol (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. In June 2016, the company initiated the Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial of ZYN002 CBD gel in refractory epilepsy patients with focal seizures and has also launched the STAR 2 open-label extension trial which allows patients who complete STAR 1 to receive treatment with ZYN002 gel for up to 52 weeks.  In August 2016, the Phase 2 STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) clinical trial in patients with knee pain due to OA was initiated. A Phase 2 clinical trial in Fragile X syndrome (FXS) is expected to initiate in the second half of 2016.  Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical trial for ZYN001 is planned to begin in the first half of 2017. Learn more at www.zynerba.com and follow the Company 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. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. 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 success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; 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. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q 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 PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
		Three months ended								Nine months ended
		September 30, 2016				September 30, 2015				September 30, 2016				September 30, 2015
Revenue		$	–			$	199,407			$	7,250			$	229,625
Operating expenses:
Research and development			4,504,097				2,271,968				11,880,264				4,136,659
General and administrative			1,493,461				1,922,755				4,649,948				3,208,003
Total operating expenses			5,997,558				4,194,723				16,530,212				7,344,662
Loss from operations			(5,997,558	)			(3,995,316	)			(16,522,962	)			(7,115,037	)
Other income (expense):
Interest income			22,747				1,572				53,243				2,948
Foreign exchange loss			(6,270	)			–				(49,668	)
Total other income (expense)			16,477				1,572				3,575				2,948
Loss before income taxes			(5,981,081	)			(3,993,744	)			(16,519,387	)			(7,112,089	)
Income tax benefit			–				–				(27,543	)			–
Net loss		$	(5,981,081	)		$	(3,993,744	)		$	(16,491,844	)		$	(7,112,089	)
Net loss per share – basic and diluted		$	(0.67	)		$	(0.66	)		$	(1.86	)		$	(2.37	)
Basic and diluted weighted average shares outstanding			8,912,508				6,045,211				8,865,854				2,998,480
Non-cash stock-based compensation included above:
Research and development		$	292,385			$	297,169			$	916,036			$	297,169
General and administrative			513,019				539,655				1,465,906				539,655
Total		$	805,404			$	836,824			$	2,381,942			$	836,824

 

ZYNERBA PHARAMCEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
		September 30, 2016				December 31, 2015
Assets
Current assets:
Cash and cash equivalents		$	31,780,773			$	41,513,060
Incentive and tax receivables			2,281,205				356,718
Prepaid expenses and other current assets			1,464,564				1,545,917
Total current assets			35,526,542				43,415,695
Property and equipment, net			304,141				227,646
Other assets			463,600				200
Total assets		$	36,294,283			$	43,643,541
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable		$	1,694,470			$	823,401
Accrued expenses			2,882,060				2,272,991
Deferred grant revenue			370,575				841,225
Total current liabilities			4,947,105				3,937,617
Deferred grant revenue, long-term			463,400				—
Total liabilities			5,410,505				3,937,617
Stockholders’ equity:
Common stock			9,628				9,200
Additional paid-in capital			69,946,049				62,276,779
Accumulated deficit			(39,071,899	)			(22,580,055	)
Total stockholders’ equity			30,883,778				39,705,924
Total liabilities and stockholders’ equity		$	36,294,283			$	43,643,541

Investor Contacts
Jim Fickenscher, CFO and VP, Corporate Development
Zynerba Pharmaceuticals
484.581.7483
Fickenscherj@zynerba.com

Kimberly Minarovich
Argot Partners
212.600.1902
kimberly@argotpartners.com 

Media Contact
Eliza Schleifstein
Argot Partners
973.361.1546
eliza@argotpartners.com

Devon, PA, November 9, 2016 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that the Company will participate at various upcoming investor meetings and conferences.

Armando Anido, Chairman and CEO, will present at the Jefferies London Healthcare Conference in London, UK, on November 17, 2016 at 2:00 pm GMT.

Jim Fickenscher, CFO and VP Corporate Development, will present at the Stifel 2016 Healthcare Conference in New York City on November 16, 2016 at 1:30 pm ET.  Mr. Fickenscher will be joined by Donna Gutterman, PharmD, VP Medical, in participation at the Maxim Group Central Nervous Disease Conference in New York City on November 17, 2016.

To listen to a webcast of the Jefferies or Stifel presentations live, please visit the Investor Relations page of www.zynerba.com. A replay of both webcasts will be available for 90 days following the conclusion of the respective event.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage 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 tetrahydrocannabinol (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. In June 2016, the company initiated the Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial of ZYN002 CBD gel in refractory epilepsy patients with focal seizures and has also launched the STAR 2 open-label extension trial which allows patients who complete STAR 1 to receive treatment with ZYN002 gel for up to 52 weeks. In August 2016, the Phase 2 STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) clinical trial in patients with knee pain due to OA was initiated. A Phase 2 clinical trial in Fragile X syndrome (FXS) is expected to initiate in the second half of 2016. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical trial for ZYN001 is planned to begin in the first half of 2017. Learn more at www.zynerba.com and follow the Company 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. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. 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 success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; 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. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q 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 Contacts
Jim Fickenscher, CFO and VP Corporate Development
Zynerba Pharmaceuticals
484.581.7483
fickenscherj@zynerba.com

Kimberly Minarovich
Argot Partners
212.600.1902
kimberly@argotpartners.com

Media Contactz
Eliza Schleifstein
Argot Partners
973.361.1546
eliza@argotpartners.com

 

Phase 1 clinical trial for ZYN001 is expected to begin in 1H17
Topline results for three Phase 2 clinical trials for ZYN002 are on track for 1H17

Devon, PA, October 17, 2016  — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today provided a development update for ZYN001 and ZYN002.

Zynerba and its development partner, LTS LOHMANN Therapie-Systeme AG (LTS), a market leader in transdermal therapeutic solutions, are working together to optimize the formulation of ZYN001 into a state of the art drug-adhesive matrix transdermal patch. ZYN001 is a patent-protected pro-drug of THC being developed for the treatment of fibromyalgia and peripheral neuropathic pain. Based on the additional optimization work in progress, Zynerba now expects to begin Phase 1 clinical trials for ZYN001 in the first half of 2017 and Phase 2 clinical trials are now planned to begin during the second half of 2017.

Three Phase 2 clinical trials with ZYN002, the first and only synthetic CBD that is formulated as a patent-protected permeation-enhanced gel, remain on track to report topline results in the first half of 2017. Two Phase 2 clinical trials are ongoing for ZYN002, in adults with refractory epilepsy and in knee pain associated with osteoarthritis. Phase 2 clinical trials in patients with Fragile X Syndrome (FXS) are on track to begin before the end of 2016.

“We are thrilled with the progress made in our development compounds – ZYN002 and ZYN001. Additionally, we are excited with the tremendous progress made by LTS in transforming ZYN001 into an optimized transdermal patch that balances efficacy with patient convenience,” said Armando Anido, Chairman and CEO. “We have completed the development of several prototypes which are smaller and more patient-friendly than our original design and believe that it is appropriate to move to this state of the art patch technology prior to initiating clinical development.”

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage 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 tetrahydrocannabinol (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. In June 2016, the company initiated the Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial of ZYN002 CBD gel in refractory epilepsy patients with focal seizures. In August 2016, the Phase 2 STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) clinical trial in patients with knee pain due to OA was initiated. A Phase 2 clinical trial in Fragile X syndrome (FXS) is expected to initiate in the second half of 2016. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical trial for ZYN001 is planned to begin in the first half of 2017. Learn more at www.zynerba.com and follow the Company 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. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration(FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. 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 success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; 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. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available atwww.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 Contacts
Jim Fickenscher, CFO and VP, Corporate Development Zynerba Pharmaceuticals 484.581.7483 Fickenscherj@zynerba.com
Kimberly Minarovich Argot Partners 212.600.1902 kimberly@argotpartners.com

Media Contact
Eliza Schleifstein Argot Partners 973.361.1546 eliza@argotpartners.com

Devon, PA, September 13, 2016 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that the Company’s Board of Directors granted James Fickenscher, the Company’s newly appointed Chief Financial Officer and Vice President, Corporate Development, an option to purchase 150,000 shares of the Company’s common stock as an inducement material to his acceptance of employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).  The option will have an exercise price equal to the closing price of Zynerba Pharmaceuticals’ common stock on September 13, 2016.  The option will vest 25% on the first anniversary of the date of the grant, with the remainder vesting in 12 equal quarterly installments thereafter, subject to Mr. Fickenscher’s continued service with the Company through the applicable vesting dates.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage 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. InJune 2016, the company initiated the Phase 2 STAR 1 clinical study of ZYN002 CBD gel in refractory epilepsy patients with focal seizures. In August, it initiated the Phase 2 STOP clinical trial in patients with knee pain associated with osteoarthritis. A Phase 2 clinical program for Fragile X syndrome (FXS) is expected to initiate in the second half of 2016. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical study for ZYN001 is planned to begin in the second half of 2016. Learn more at www.zynerba.com and follow the Company 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. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. 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 success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; 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. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q 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
Kimberly Minarovich Argot Partners 212.600.1902 kimberly@argotpartners.com

Media Contact
Eliza Schleifstein Argot Partners 973.361.1546 eliza@argotpartners.com

DEVON, PA, September 6, 2016  – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that the Company will present at various upcoming investor meetings and conferences, including:

• The Rodman & Renshaw 18th Annual Global Investment Conference on September 12, 2016 at 10:50 am Eastern Daylight Time. The conference will take place at the Lotte New York Palace Hotel in New York City.
• The Morgan Stanley Global Healthcare Conference on September 13, 2016 at 4:05 pm Eastern Daylight Time. The conference will take place at the Grand Hyatt in New York City.

To listen to a webcast of the presentations live, please visit the Investor Relations page of www.zynerba.com. A replay of both webcasts will be available for 90 days following the conclusion of the respective event.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage 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 tetrahydrocannabinol (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. In June 2016, the company initiated the Phase 2 STAR 1 clinical study of ZYN002 CBD gel in refractory epilepsy patients with focal seizures. In August 2016, the STOP trial in patients with knee pain due to OA was initiated. A Phase 2 study in Fragile X syndrome (FXS) is expected to initiate in the second half of 2016. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical study for ZYN001 is planned to begin in the second half of 2016. Learn more at www.zynerba.com and follow the Company 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. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. 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 success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; 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. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q 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 Contacts
Richard Baron, CFO Zynerba Pharmaceuticals 484.581.7505 baronr@zynerba.com
Kimberly Minarovich Argot Partners 212.600.1902 kimberly@argotpartners.com

Media Contact
Eliza Schleifstein Argot Partners 973.361.1546 eliza@argotpartners.com

DEVON, PA, September 6, 2016 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that it has initiated a Phase 2 clinical trial, STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis (OA)), of ZYN002 cannabidiol (CBD) gel. ZYN002 CBD gel is the first and only patent-protected, synthetic CBD that is formulated as a permeation-enhanced gel for transdermal delivery.

“In the US, there are approximately 31 million people who suffer from osteoarthritis, many of whom are not receiving adequate relief from current therapies,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “In preclinical models, cannabidiol has demonstrated the ability to significantly reduce pain and inflammation associated with OA. ZYN002 may offer an effective treatment alternative to NSAIDs and narcotic opioids with an improved safety profile.”

The STOP clinical trial is a Phase 2 multi-center, double-blind, placebo-controlled, multi-dose clinical trial designed to evaluate the efficacy and safety of ZYN002 in patients with knee pain due to OA. Up to 300 patients will be enrolled in the clinical trial and will be followed for two weeks during a baseline phase, which includes a one-week washout period. After completion of the baseline phase, patients will be randomized 1:1:1 to receive either 250 mg of ZYN002 4.2% CBD gel every 12 hours, 125 mg of ZYN002 4.2% CBD gel every 12 hours or placebo gel every 12 hours for 12 weeks. The primary endpoint of the study is the change from baseline in the weekly mean of the 24-hour average worst pain score. The Company expects to report topline results in the first half of 2017.

About ZYN002 CBD Gel
Zynerba’s ZYN002 CBD gel is the first and only synthetic CBD that is formulated as a patent-protected permeation-enhanced gel. Phase 2 clinical studies are ongoing in adults with refractory epilepsy and in knee pain associated with osteoarthritis. Phase 2 clinical studies in patients with Fragile X Syndrome (FXS) are expected to begin in the second half of 2016. ZYN002 is a clear, permeation-enhanced gel that is designed to provide consistent, controlled drug delivery transdermally with convenient twice-daily dosing. Transdermal therapeutics are absorbed through the skin directly into the systemic circulation, avoiding first-pass liver metabolism and potentially enabling lower dosage levels of active pharmaceutical ingredients and rapid and reliable absorption with high bioavailability. In addition, transdermal delivery avoids the gastrointestinal tract and potential stomach acid degradation of CBD into THC (associated with psychoactive effects), as demonstrated in a Zynerba in vitro study.

About Osteoarthritis
Osteoarthritis is a degenerative joint disease that leads to wear and tear of the joints and affects the cartilage, joint lining, ligaments and bone. It is the most common form of joint disease and tends to occur most often in the hand joints, spine, hip, knees and great toes. It is characterized by the breakdown of the joint cartilage, bony changes in the joints and deterioration of the tendons and ligaments leading to pain and inflammation of the joint lining. Approximately 31 million patients in the US suffer from osteoarthritis.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage 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 tetrahydrocannabinol (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. In June 2016, the company initiated the Phase 2 STAR 1 clinical study of ZYN002 CBD gel in refractory epilepsy patients with focal seizures. In August 2016, the STOP trial in patients with knee pain due to OA was initiated. A Phase 2 study in Fragile X syndrome (FXS) is expected to initiate in the second half of 2016. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical study for ZYN001 is planned to begin in the second half of 2016. Learn more at www.zynerba.com and follow the Company 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. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. 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 success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; 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. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q 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
Kimberly Minarovich Argot Partners 212.600.1902 kimberly@argotpartners.com

Media Contact
Eliza Schleifstein Argot Partners 973.361.1546 eliza@argotpartners.com

Jim Fickenscher will assume role as Chief Financial Officer, VP, Corporate Development

Dr. Nancy Tich appointed VP, Clinical, in a newly created position

Devon, PA, August 11, 2016 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today reported financial results for the second quarter ended June 30, 2016 and changes to the Company’s executive management team.

Zynerba announced that Jim Fickenscher will replace Richard Baron as Chief Financial Officer, Vice President, Corporate Development, effective September 13, 2016. Mr. Fickenscher joins Zynerba with 28 years of experience in the pharmaceutical industry. Most recently, he was Senior Vice President, Chief Financial Officer at Antares Pharma, a commercial pharmaceutical company focused on self-administered parenteral products. He has also held roles as CFO at Auxilium Pharmaceuticals and Aventis Behring LLC, a wholly owned subsidiary of Aventis, predecessor to Sanofi S.A, as well as business development and strategic planning positions. Mr. Baron will remain with the Company through the transition into September.

Zynerba also announced the appointment of Nancy Tich, MS, Ph.D, as Vice President, Clinical, a newly created position. Dr. Tich joins Zynerba with more than 26 years of clinical project management experience. Most recently, Dr. Tich served as Senior Director, Project Management, at Covance. She has also held senior clinical roles at Omnicare, Elan Pharmaceuticals and Abbott Laboratories.

“During the quarter, Zynerba achieved several clinical milestones and strengthened the organization. We achieved a significant milestone with our lead development compound, ZYN002, including initiation of a Phase 2 clinical study in epilepsy patients. We are also pleased to welcome two new additions to our executive management team. Jim Fickenscher, who will join us on September 13, is a seasoned executive in the pharmaceutical industry who has been the CFO for other biopharmaceutical companies, including Auxilium during my tenure as CEO.  He brings a wealth of financial and corporate development experience and I look forward to working with him again and building Zynerba into a leading specialty pharmaceutical company,” said Armando Anido, Chairman and CEO. “We also welcome Dr. Nancy Tich, who joined us in June, to our clinical team. She brings nearly three decades of experience to her role as Vice President, Clinical, and her knowledge will be invaluable as Zynerba advances its lead product candidate in the clinic.”

Mr. Anido continued, “We deeply appreciate Rick Baron’s numerous contributions, particularly his leadership through our listing on the Nasdaq in August 2015. On behalf of the entire company, we thank Rick for his financial expertise and friendship. We wish him much success as he pursues new personal and professional endeavors.”

Clinical Highlights from the Second Quarter 2016
Initiated Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial for ZYN002 CBD gel in refractory epilepsy: Zynerba initiated the baseline phase of the STAR 1clinical study in refractory epilepsy patients with focal seizures in June. The Company announced in August that patients had begun randomization and dosing. The STAR 1 trial expects to enroll up to 180 refractory epilepsy patients who will receive either 97.5 mg of ZYN002 4.2% CBD gel, 195 mg of ZYN002 4.2% CBD gel, or placebo gel twice daily. The primary endpoint will assess the median percentage change in seizure frequency over the 12-week treatment period. Safety and tolerability will also be evaluated. Top line results are expected to be reported in the first half of 2017.

Reported top line results from a 7-day Phase 1 Multiple Rising Dose trial for ZYN002 CBD gel: The 7-day Phase 1 trial included 24 healthy volunteers ranging from 25 to 53 years old and 12 epilepsy patients from 19 to 65 years old. These results confirmed that ZYN002 CBD gel was safe and well-tolerated at all dose levels ranging from 200 to 500 mg CBD daily in 1% and 2.5% ZYN002 formulations.

Reported top line results from a 14-day Phase 1 Multiple Rising Dose trial for ZYN002 CBD gel: In this trial, 42 healthy volunteers received a range of CBD doses from 395 mg to 504 mg daily in 2.5% and 4.2% ZYN002 formulations for 14 days. ZYN002 was safe and very well tolerated with minimal skin erythema. The 4.2% formulation demonstrated a comparable pharmacokinetic and tolerability profile to the 2.5% concentration and was easier to use due to its lower volume.

Reported final results from a Phase 1 Single Rising Dose trial: These results confirmed initial findings that ZYN002 CBD gel was safe and well tolerated in healthy volunteers and patients with epilepsy across a wide range of doses.

Anticipated 2016 Clinical Milestones
ZYN002, synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery 

• Zynerba plans to initiate additional Phase 2 trials in osteoarthritis (OA) and Fragile X syndrome (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.

Second Quarter 2016 Financial Results
As of June 30, 2016, cash and cash equivalents were $32.1 million, compared to $36.8 million as of March 31, 2016.

Research and development expenses for the second quarter of 2016 were $4.8 million, including stock-based compensation of $0.4 million. General and administrative expenses for the second quarter of 2016 were $1.5 million, including stock-based compensation expense of $0.4 million. Net loss for the second quarter of 2016 was $6.2 million with basic and diluted net loss per share of $0.70.

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 top line results for the five indications being evaluated for ZYN002 and ZYN001.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage 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. InJune 2016, the Company initiated the STAR 1 Phase 2 clinical study of ZYN002 CBD gel in refractory epilepsy patients with focal seizures. Phase 2 studies in osteoarthritis and Fragile X syndrome (FXS) are expected to initiate in the second half of 2016. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical study for ZYN001 is planned to begin in the second half of 2016. Learn more atwww.zynerba.com and follow the Company on Twitter at @ZynerbaPharma.

Non-GAAP Financial Measures
The non-GAAP financial information contained herein is a supplement to the corresponding financial measures prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). Non-GAAP measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared. Management uses adjusted EBITDA (defined as earnings before interest, income taxes, depreciation, amortization, stock-based compensation and foreign currency loss) in its evaluation of the Company’s core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Management believes that this non-GAAP financial information reflects an additional way of viewing aspects of our business that, when viewed with our GAAP results, provide a more complete understanding of factors and trends affecting our business. Please see the section of this press release titled “Reconciliation of Adjusted EBITDA.”

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. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration(FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. 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 success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; 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. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q 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 PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
		Three months ended									Six months ended
		June 30, 2016					June 30, 2015				June 30, 2016					June 30, 2015
Revenue		$	–				$	15,390			$	7,250				$	30,218
Operating expenses:
Research and development			4,807,177					1,010,989				7,376,167					1,864,693
General and administrative			1,476,357					631,474				3,156,487					1,285,247
Total operating expenses			6,283,534					1,642,463				10,532,654					3,149,940
Loss from operations			(6,283,534	)				(1,627,073	)			(10,525,404	)				(3,119,722	)
Other income (expense):
Interest income			18,118					697				30,496					1,377
Foreign exchange loss			(20,250	)				–				(43,398	)
Total other income (expense)			(2,132	)				697				(12,902	)				1,377
Loss before income taxes			(6,285,666	)				(1,626,376	)			(10,538,306	)				(3,118,345	)
Income tax benefit			(56,277	)				–				(27,543	)				–
Net loss		$	(6,229,389	)			$	(1,626,376	)		$	(10,510,763	)			$	(3,118,345	)
Net loss per share – basic and diluted		$	(0.70	)			$	(1.12	)		$	(1.19	)			$	(2.15	)
Basic and diluted weighted average shares outstanding			8,860,592					1,449,865				8,842,271					1,449,865

 

ZYNERBA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
		June 30, 2016				December 31, 2015
Assets
Current assets:
Cash and cash equivalents		$	32,133,048			$	41,513,060
Incentive and tax receivables			1,692,315				356,718
Prepaid expenses and other current assets			1,768,994				1,545,917
Total current assets			35,594,357				43,415,695
Property and equipment, net			209,287				227,646
Other assets			200				200
Total assets		$	35,803,844			$	43,643,541
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable		$	2,681,122			$	823,401
Accrued expenses			1,517,048				2,272,991
Deferred grant revenue			833,975				841,225
Total current liabilities			5,032,145				3,937,617
Stockholders’ equity:
Common stock			9,200				9,200
Additional paid-in capital			63,853,317				62,276,779
Accumulated deficit			(33,090,818	)			(22,580,055	)
Total stockholders’ equity			30,771,699				39,705,924
Total liabilities and stockholders’ equity		$	35,803,844			$	43,643,541

 

ZYNERBA PHARMACEUTICALS, INC.
RECONCILIATION OF ADJUSTED EBITDA
(Unaudited)
		Three months ended								Six months ended
		June 30, 2016				June 30, 2015				June 30, 2016				June 30, 2015
GAAP Net loss		$	(6,229,389	)		$	(1,626,376	)		$	(10,510,763	)		$	(3,118,345	)
Add back:
Depreciation			13,892				3,095				27,450				4,542
Interest income			(18,118	)			(697	)			(30,496	)			(1,377	)
Income tax benefit			(56,277	)			–				(27,543	)			–
EBITDA			(6,289,892	)			(1,623,978	)			(10,541,352	)			(3,115,180	)
Add back:
Stock-based compensation			812,739				–				1,576,538				–
Foreign exchange loss			20,250				–				43,398				–
Adjusted EBITDA		$	(5,456,903	)		$	(1,623,978	)		$	(8,921,416	)		$	(3,115,180	)

 

Investor Contacts
Richard Baron, CFO
Zynerba Pharmaceuticals
484.581.7505
baronr@zynerba.com

Kimberly Minarovich
Argot Partners
212.600.1902
kimberly@argotpartners.com

Media Contact
Eliza Schleifstein
Argot Partners
973.361.1546
eliza@argotpartners.com

Devon, PA, August 03, 2016 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that the Company will present at Canaccord Genuity’s 36^th Annual Growth Conference. The conference will be held August 10 to 11, at the InterContinental Boston. Zynerba Chairman and CEO Armando Anido will present on Wednesday, August 10, at 12:00 pm Eastern Daylight Time.

To listen to a webcast of the Canaccord presentation during the event, please visit the Investor Relations page of www.zynerba.com. A replay of this webcast will be available for 90 days following the conference.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage 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. InJune 2016, the company initiated the Phase 2 STAR 1 clinical study of ZYN002 CBD gel in refractory epilepsy patients with focal seizures.  Phase 2 studies in osteoarthritis and Fragile X syndrome (FXS) are expected to initiate in the second half of 2016.  Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical study for ZYN001 is planned to begin in the second half of 2016. Learn more atwww.zynerba.com and follow the Company 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. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration(FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. 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 success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; 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. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available atwww.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 Contacts
Richard Baron, CFO
Zynerba Pharmaceuticals
484.581.7505
baronr@zynerba.com

Kimberly Minarovich
Argot Partners
212.600.1902
kimberly@argotpartners.com

Media Contact
Eliza Schleifstein
Argot Partners
973.361.1546
eliza@argotpartners.com

Devon, PA, August 01, 2016 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that the first patients have been dosed in the Company’s Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial, a randomized, multi-center, multi-dose study to evaluate ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal seizures.  ZYN002 CBD gel is the first and only synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery and is in development for the treatment of epilepsy, osteoarthritis (OA) and Fragile X syndrome (FXS).

The STAR 1 clinical trial will evaluate ZYN002 CBD gel in 180 refractory epilepsy patients. The study includes an 8-week baseline period to assess seizure frequency and type.  As patients complete the baseline period, they will be randomized 1:1:1 to receive (i)195 mg of ZYN002 4.2% CBD gel every 12 hours, (ii) 97.5 mg of ZYN002 4.2% CBD gel every 12 hours or (iii) placebo gel every 12 hours for 12 weeks. The primary endpoint will assess the median percentage change in seizure frequency over the 12-week treatment period.  Safety and tolerability will also be evaluated.  The study is being conducted at 14 sites in Australia and New Zealand. Top line results are expected to be reported in the first half of 2017.

“The dosing of the first patients in the STAR 1 clinical trial in adults with refractory epilepsy is a significant milestone for the Company,” said Armando Anido, Chairman and CEO of Zynerba Pharmaceuticals. “We are pleased by the pace of the clinical program for ZYN002 and remain on track to initiate additional Phase 2 studies in OA and FXS in the second half of this year. We expect to report top line results from all three studies in the first half of 2017.”

The Phase 2 STAR 1 clinical trial is supported by three Phase 1 trials: 1, 7, and 14-day trials with CBD gel doses ranging from 50 mg to 504 mg daily.  In the 14-day trial, Zynerba compared a 2.5% CBD concentration to a 4.2% concentration for pharmacokinetics, tolerability and ease of use.  The Company found the 4.2% concentration demonstrated a comparable pharmacokinetic and tolerability profile to the 2.5% concentration with an easier to use, lower volume formulation.

About ZYN002 CBD Gel
Zynerba’s ZYN002 CBD gel is the first and only synthetic CBD formulated as a patent-protected permeation-enhanced gel and is being studied in refractory epilepsy, Fragile X syndrome and osteoarthritis. ZYN002 is a clear, permeation-enhanced gel that is designed to provide consistent, controlled drug delivery transdermally with twice-daily dosing. Transdermal therapeutics are absorbed through the skin directly into the systemic circulation, avoiding first-pass liver metabolism and potentially enabling lower dosage levels of active pharmaceutical ingredients and rapid and reliable absorption with high bioavailability. In addition, transdermal delivery avoids the gastrointestinal tract and potential stomach acid degradation of CBD into THC (associated with psychoactive effects), as demonstrated in a Zynerba-sponsored in vitro study.

About Epilepsy
Epilepsy is a disease characterized by an enduring predisposition to generate epileptic seizures (transient symptoms due to abnormal neuronal activity in the brain) and by the neurobiological, cognitive, psychological and social consequences of the condition. Focal seizures usually start in a small area of the temporal lobe or frontal lobe of the brain and quickly involve other areas of the brain that affect alertness and awareness. Approximately 2.2 million patients in the United States and 3.1 in Europe and Japan battle epilepsy. Focal seizures are the most common type of seizure, representing 35% of all epilepsies.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage 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. InJune 2016, the company initiated the Phase 2 STAR 1 clinical study of ZYN002 CBD gel in refractory epilepsy patients with focal seizures.  Phase 2 studies in osteoarthritis and Fragile X syndrome (FXS) are expected to initiate in the second half of 2016.  Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical study for ZYN001 is planned to begin in the second half of 2016. Learn more atwww.zynerba.com and follow the Company 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. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. 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 success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; 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. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q 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 Contacts
Richard Baron, CFO
Zynerba Pharmaceuticals
484.581.7505
baronr@zynerba.com

Kimberly Minarovich
Argot Partners
212.600.1902
kimberly@argotpartners.com

Media Contact
Eliza Schleifstein
Argot Partners
973.361.1546
eliza@argotpartners.com