Author: Jennifer Guinan

Company to host conference call and webcast today, August 7 at 8:30am ET

Devon, PA, August 7, 2017 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative transdermal pharmaceutically-produced cannabinoid treatments, today announced top-line results from its double-blind placebo controlled Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial evaluating ZYN002 (cannabidiol [CBD] gel) in adult epilepsy patients with focal seizures. ZYN002 did not demonstrate a statistically significant reduction of focal seizures during the treatment period compared to the baseline period for either the high or low dose cohorts compared to placebo.

“We are very disappointed that the STAR 1 trial did not meet its primary endpoint in this patient population,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We are continuing to evaluate this study and the ongoing STAR 2 open label study to determine next steps with ZYN002 in adult epilepsy patients with focal seizures. I’d like to thank the patients, coordinators and investigators, as well as the development team at Zynerba, for their time and energies in conducting this very important trial.”

Anido continued, “Importantly, today’s results demonstrated ZYN002 to have a very favorable safety and tolerability profile, which is an encouraging fact as we look to develop ZYN002 as a treatment for a wide range of indications. We are excited that we will present top-line data from our ZYN002 STOP trial in osteoarthritis soon, followed by top-line data from our FAB-C study in Fragile X syndrome by the end of September.”

In the double-blind, multi-center STAR 1 trial, 188 patients were randomized 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. Patients aged 18 to 71 years old with confirmed refractory epilepsy with focal seizures with or without secondary generalization were enrolled in this study. Enrolled patients had a median monthly seizure frequency of 10.6, and were on an average of 2.5 anti-epileptic drugs (AEDs). The primary endpoint assessed the median percentage change in seizure frequency over the 12-week treatment period compared to the 8-week baseline period. Secondary endpoints included proportion of patients with ≥50% reduction from baseline in seizure frequency, percent change from baseline in seizure frequency, change from baseline in seizure frequency, seizure-free days, and 100% seizure free. Safety and tolerability were also evaluated. The study was conducted at 14 sites in Australia and New Zealand.  The efficacy analysis included 186 patients.

• Primary Endpoint Data: Patients on the low dose of ZYN002 (n=63) achieved an 18.4% median reduction in focal seizures during the treatment period compared to baseline; patients on the high dose of ZYN002 (n=62) achieved a 14.0% median reduction in focal seizures during the treatment period compared to baseline; and patients on placebo (n=63) achieved an 8.7% median reduction in focal seizures during the treatment period compared to baseline.
• Secondary Endpoint Data: None of the secondary endpoints showed statistically significant differences between ZYN002 and placebo.
• Safety Data: ZYN002 was shown to be very well tolerated and the safety profile was consistent with previously released data from the Phase 1 trials. Of the 188 patients in the safety database, 50% of the patients on ZYN002 (n=63) had at least one treatment emergent adverse event, compared to 41% (n=26) of patients on placebo. Two treatment emergent adverse events occurred in greater than 5% of the patients on ZYN002: fatigue (5.6%, placebo, 1.6%) and headache (5.6%, placebo, 3.2%). There were no treatment related serious adverse events reported. The discontinuation rate in the trial for ZYN002 was 10.4% compared to 1.6% in placebo.
• Pharmacokinetic Data: ZYN002 high and low dose median plasma concentrations were dose proportional, with the high dose levels being approximately two times the concentration of the low dose. Despite the dose proportionality, there was no correlation between plasma levels and efficacy.

Additional studies of ZYN002

Zynerba is evaluating the utility of ZYN002 in other indications. Enrollment is complete in its Phase 2 STOP (Synthetic Transdermal Cannabidiol for Treatment of Knee Pain due to Osteoarthritis) study in patients with osteoarthritis, and in its exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) study in children with Fragile X syndrome (FXS). Delivery of top line data from these studies is on track for August and by the end of September 2017, respectively.

Conference Call Information

Zynerba management will host a live conference call and webcast today at 8:30 am Eastern Time to discuss the results of this clinical trial. The call can be accessed by dialing (866) 573-0180 (U.S. and Canada) or (430) 775-1345 (international) and referencing conference ID 64535355. To access the live webcast or the replay, visit the investor page of the Company’s website at http://ir.zynerba.com/. The webcast will be recorded and available on the Company’s website for 30 days.

About Our Technology

Cannabinoids are a class of chemical compounds found in the Cannabis plant. The two primary cannabinoids contained in Cannabis are cannabidiol, or CBD, and ∆9-tetrahydrocannabinol, or THC. Clinical and preclinical data support the potential for CBD in treating epilepsy, arthritis and Fragile X Syndrome, and THC has positive effects on treating pain. Zynerba is developing therapeutic medicines that utilize innovative transdermal technologies that, if successful, may allow for sustained and controlled delivery of therapeutic levels of CBD and THC. Transdermal delivery of cannabinoids may have benefits over oral dosing because it allows the drug to be absorbed through the skin directly into the bloodstream. This avoids first-pass liver metabolism, potentially enabling lower dosage levels of active pharmaceutical ingredients with a higher bioavailability and improved safety profile. Transdermal delivery also avoids the gastrointestinal tract, lessening the opportunity for GI related adverse events and the potential degradation of CBD by gastric acid into THC, which may be associated with unwanted psychoactive effects. Using an established chemical pharmaceutical process for manufacturing, Zynerba replicates the CBD and THC found in the Cannabis plant. We believe that this will allow us to meet stringent global regulatory agencies’ standards while ensuring that we can efficiently supply the amount of product required to meet the demand of the large markets that we are targeting.

About ZYN002

Zynerba’s ZYN002 CBD gel is the first and only pharmaceutically-produced CBD formulated as a patent-protected permeation-enhanced gel and is being studied in adult epilepsy patients with focal seizures, in osteoarthritis and in children with Fragile X Syndrome. ZYN002 is a clear, permeation-enhanced gel that is designed to provide controlled drug delivery transdermally with once- or twice-daily dosing.

About Zynerba Pharmaceuticals, Inc.

Zynerba Pharmaceuticals (NASDAQ: ZYNE) is dedicated to improving the lives of people with severe health conditions where there is a high unmet medical need by developing and commercializing pharmaceutically-produced transdermal cannabinoid medicines designed to meet the rigorous efficacy and safety standards established by global regulatory agencies. Through the discovery and development of these life-changing medicines, Zynerba seeks to improve the lives of patients battling severe, chronic health conditions including epilepsy, Fragile X syndrome, osteoarthritis, fibromyalgia and peripheral neuropathic pain. 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. 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.

Zynerba Contacts
Jim Fickenscher, CFO and VP Corporate Development
484.581.7483
fickenscherj@zynerba.com

Will Roberts, VP Investor Relations and Corporate Communications
484.581.7489
robertsw@zynerba.com

Media Contact
Theresa Dolge
Tonic Life Communications
Office: 215-928-2748
Theresa.Dolge@toniclc.com

 

Top-line Phase 2 results for STAR 1 trial in epilepsy and STOP trial in osteoarthritis remain on track for reporting in August 2017

Devon, PA, August 1, 2017 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative transdermal synthetic cannabinoid treatments, today reported financial results for the second quarter ended June 30, 2017 and provided an overview of recent operational highlights.

“We expect to announce top-line results from the STAR 1 trial soon, followed by top-line data from the STOP trial later this month; and we remain on track to report top-line results from the FAB-C Fragile X study in September,” said Armando Anido, Chairman and Chief Executive Officer. “We also met a significant milestone during the quarter in initiating the Phase 1 program for ZYN001, a pro-drug of THC delivered via patch, and expect to initiate our Phase 2 program by the end of this year. With two clinical stage assets, Zynerba is well-positioned to address a number of serious unmet medical needs.”

Second Quarter 2017 and Recent Highlights

Completed Dosing in Phase 2 STAR 1 Clinical Trial for ZYN002 Cannabidiol (CBD) Gel in Adult Epilepsy Patients; Top Line Data Expected Soon

A total of 188 patients were randomized in the Phase 2 STAR 1 double-blind, placebo-controlled clinical trial in adult patients with refractory epilepsy, exceeding the 180-patient enrollment target. Following randomization, patients were dosed with either 195 mg or 390 mg of CBD in ZYN002 4.2% gel or placebo daily for 12 weeks. The primary endpoint of the trial is the median reduction in seizure frequency per 28-day period compared to baseline.

Dosing Continues in Phase 2 STAR 2 Open-Label Extension Clinical Trial for ZYN002 CBD Gel in Adult Epilepsy Patients

Ninety-eight percent of the patients who completed the STAR 1 trial elected to enroll into the STAR 2 trial, designed to evaluate long-term safety and tolerability of ZYN002 CBD gel across a range of doses. In the open-label extension study, patients receive a high or low-dose of ZYN002 (390 mg or 195 mg of CBD in ZYN002 4.2% gel daily, respectively) for up to 52 weeks.

Completed Dosing of Phase 2 STOP Clinical Trial for ZYN002 CBD Gel in Adult Osteoarthritis Patients; Top Line Data Expected this Month

Dosing is complete in the randomized, double-blind, placebo-controlled Phase 2 STOP trial in osteoarthritis of the knee. We exceeded the initial target enrollment of 300 patients with 320 patients randomized into one of three dosing groups. Patients received either 250 mg or 500 mg of CBD in ZYN002 4.2% gel or placebo daily for 12 weeks. The primary endpoint of the trial is the change from baseline in the weekly mean of the 24-hour average worst pain score at week 12.

Completed Enrollment in FAB-C Exploratory Phase 2 Clinical Trial of ZYN002 CBD Gel in Pediatric Fragile X Syndrome Patients; Top Line Data Expected in September 2017

Enrollment is complete and dosing is ongoing in the Phase 2 exploratory FAB-C clinical trial designed to evaluate the safety and efficacy of ZYN002 CBD gel administered over a 12-week period in pediatric patients with Fragile X syndrome (FXS). We exceeded the initial target enrollment of 16 patients with 20 patients enrolled. The study is evaluating 50 mg of CBD in ZYN002 4.2% gel once daily, which may be titrated up to 125 mg two times per day during the six-week titration period. Between weeks six and twelve, patients receive a maintenance dose of 50 mg, 100 mg or 250 mg daily of CBD in ZYN002 4.2% gel. The primary objective is to assess intra-patient changes in anxiety, depression and mood (as measured by the ADAMS scale) versus baseline. The U.S. Food and Drug Association has granted orphan-drug designation to ZYN002 CBD gel for the treatment of Fragile X syndrome.

Initiated Phase 1 Program for ZYN001 Pro-drug of Tetrahydrocannabinol (THC) Delivered via Transdermal Patch

The company has initiated a Phase 1 program to assess ZYN001, a patent-protected, pro-drug of THC delivered via a patch. This first in man study is a randomized, double-blind, placebo-controlled Phase 1 trial. First, the safety, tolerability and pharmacokinetic profile of a single dose of ZYN001 versus placebo will be evaluated. Several formulations and patch wear times ranging from 24 hours to 7 days will be assessed in up to 48 healthy subjects. Based on results from the single dose portion of this trial, two formulations will be evaluated in multiple patch applications for 14 days in up to 32 healthy subjects who will be randomized 3:1 to ZYN001 or placebo. Results from this study will inform the planned Phase 2 program for ZYN001 in fibromyalgia and neuropathic pain, expected to initiate in the fourth quarter of 2017.

Second Quarter 2017 Financial Results

As of June 30, 2017, cash and cash equivalents were $70.2 million, compared to $77.5 million as of March 31, 2017. Research and development expenses for the second quarter of 2017 were $5.7 million, including stock-based compensation of $0.6 million. General and administrative expenses for the second quarter of 2017 were $2.6 million, including stock-based compensation expense of $0.8 million. Net loss for the second quarter of 2017 was $8.3 millionwith basic and diluted net loss per share of $0.64.

Financial Outlook

The Company believes that the current cash and cash equivalent position of $70.2 million is sufficient to develop five Phase 3-ready programs and, assuming support from the FDA to move forward, initiate at least one Phase 3 program and fund operations and capital requirements into 2019.

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 March 2017, the Company completed enrollment in 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, the most common form of epilepsy in adults. Also in March 2017, 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 osteoarthritis was fully enrolled. In June 2017, the Company completed enrollment in its exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial in children with Fragile X syndrome. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical program for ZYN001 was initiated in the second quarter 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. In addition, the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated. 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. 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.

ZYNERBA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
		Three months ended								Six months ended
		June 30, 2017				June 30, 2016				June 30, 2017				June 30, 2016
Revenue		$	—			$	—			$	—			$	7,250
Operating expenses:
Research and development			5,732,797				4,807,177				11,224,252				7,376,167
General and administrative			2,632,857				1,476,357				4,844,650				3,156,487
Total operating expenses			8,365,654				6,283,534				16,068,902				10,532,654
Loss from operations			(8,365,654	)			(6,283,534	)			(16,068,902	)			(10,525,404	)
Other income (expense):
Interest income			124,535				18,118				201,420				30,496
Foreign exchange (loss) gain			(82,360	)			(20,250	)			284,982				(43,398	)
Total other income (expense)			42,175				(2,132	)			486,402				(12,902	)
Loss before income taxes			(8,323,479	)			(6,285,666	)			(15,582,500	)			(10,538,306	)
Income tax expense			—				(56,277	)			—				(27,543	)
Net loss		$	(8,323,479	)		$	(6,229,389	)		$	(15,582,500	)		$	(10,510,763	)
Net loss per share – basic and diluted		$	(0.64	)		$	(0.70	)		$	(1.24	)		$	(1.19	)
Basic and diluted weighted average shares outstanding			13,052,294				8,860,592				12,562,594				8,842,271
Non-cash stock-based compensation included above:
Research and development		$	588,713			$	374,919			$	1,130,558			$	623,651
General and administrative			766,661				437,820				1,413,515				952,887
Total		$	1,355,374			$	812,739			$	2,544,073			$	1,576,538

 

ZYNERBA PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (Unaudited)
		June 30, 2017				December 31, 2016
Assets
Current assets:
Cash and cash equivalents		$	70,179,199			$	30,965,791
Incentive and tax receivables			3,971,828				3,613,943
Prepaid expenses and other current assets			2,307,466				1,830,958
Total current assets			76,458,493				36,410,692
Property and equipment, net			177,994				143,382
Incentive and tax receivables			2,456,286				—
Other assets			200				200
Total assets		$	79,092,973			$	36,554,274
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	2,024,991			$	1,848,084
Accrued expenses			5,004,856				4,284,907
Deferred grant revenue			833,975				833,975
Total current liabilities			7,863,822				6,966,966
Stockholders’ equity:
Common stock			13,257				9,995
Additional paid-in capital			132,766,956				75,545,875
Accumulated deficit			(61,551,062	)			(45,968,562	)
Total stockholders’ equity			71,229,151				29,587,308
Total liabilities and stockholders’ equity		$	79,092,973			$	36,554,274

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

Will Roberts, VP Investor Relations and Corporate Communications
Zynerba Pharmaceuticals
484.581.7489
robertsw@zynerba.com

Devon, PA, July 28, 2017 – It is with great sadness that Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) mourns the death of Director Cynthia A. Rask, M.D.

“All of the Zynerba family are mourning the loss of Cynthia, our friend and Director,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “Cynthia was a wonderful person, an important contributor to our board, and a strong believer and supporter of the work we are doing at Zynerba. With the rest of our team, I offer my most sincere sympathies to the Rask family during this difficult time.”

Dr. Rask, an accomplished pharmaceutical and biotechnology veteran, joined the Zynerba Board of Directors in August 2015, where she was instrumental in developing Zynerba’s focus in epilepsy. She trained in Internal Medicine and Neurology at the University of Rochester and was board-certified in Neurology and in Clinical Neurophysiology. During her time at FDA, she served as division director for the Division of Clinical Evaluation and Pharmacology/Toxicology in the Office of Cellular, Tissue and Gene Therapies (OCTGT) Dr. Rask earned her degrees at Cornell University and the University of Minnesota Medical School.

Zynerba Contact
William Roberts, Vice President, Investor Relations and Corporate Communications
Zynerba Pharmaceuticals
484.581.7489
robertsw@zynerba.com

Devon, PA, June 26, 2017 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative transdermal synthetic cannabinoid treatments, today announced that it has been added to the Russell 3000^® Index as part of the FTSE’s annual reconstitution of its family of U.S. indexes. The addition will take effect after the U.S. market opens on June 26.

Annual Russell index reconstitution captures the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000^® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000^® Index or small-cap Russell 2000^® Index as well as the appropriate growth and value style indexes.

The Russell 2000^® Index measures the performance of the small-cap segment of the U.S. equity universe. The index is a subset of the Russell 3000^® Index and includes approximately 2,000 securities based on a combination of their market cap and current index membership.

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 March 2017, the Company completed enrollment in 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, the most common form of epilepsy in adults. Also in March 2017, 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 osteoarthritis was fully enrolled. In June 2017, the Company completed target enrollment in its exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial in children with Fragile X syndrome. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical study for ZYN001 was initiated in the second quarter of 2017. Learn more at www.zynerba.com and follow the Company on Twitter at @ZynerbaPharma.

Cautionary Statement on Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including the Company’s expectations regarding the completion, timing and size of the option exercise, the Company’s anticipated proceeds therefrom and other statements containing the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend,” “expect” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering, as well as other risks and uncertainties discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date of this press release. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Zynerba Contact
William Roberts, Vice President, Investor Relations and Corporate Communications
Zynerba Pharmaceuticals
484.581.7489
robertsw@zynerba.com

Phase 1 results will inform potential Phase 2 studies in patients with fibromyalgia and neuropathic pain, planned to start in 2H17

Study includes single rising dose and multiple rising dose evaluations

Devon, PA, June 26, 2017 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative transdermal synthetic cannabinoid treatments, today announced that it has initiated its ZYN001 Phase 1 clinical program to study the company’s patent-protected, pro-drug of tetrahydrocannabinol (THC) delivered via a transdermal patch. This study will assess single and multiple rising doses of several formulations of ZYN001 to identify the optimal dose to take into Phase 2 studies.

“The initiation of the ZYN001 clinical program is an important milestone for the Company, as we now have two clinical stage assets which upon approval may address serious unmet medical needs in a variety of disease settings,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We believe that ZYN001 will be important in a number of pain indications, given THC’s known impact on pain transmission and analgesic effect in patients suffering from chronic pain. Our state-of-the-art transdermal patch delivery offers unique advantages to patients, including the potential for more consistent, sustained delivery and better tolerability of THC.”

This first in man study is a randomized, double-blind, placebo-controlled Phase 1 trial. First, the safety, tolerability and pharmacokinetic profile of a single dose of ZYN001 versus placebo will be evaluated. Several formulations and patch wear times ranging from 24 hours to 7 days will be assessed in up to 48 healthy subjects. Based on results from the single dose portion of this trial, two formulations will be evaluated in multiple patch applications for 14 days in up to 32 healthy subjects who will be randomized 3:1 to ZYN001 or placebo. The goal is to deliver constant levels of THC to optimize efficacy while minimizing CNS side effects. With the successful completion of this single and multiple dose study, a Phase 2 program for ZYN001 in fibromyalgia and neuropathic pain is planned to start in the second half of 2017.

About ZYN001 THC Pro-Drug Patch
ZYN001 is a synthetic pro‑drug of THC in a state-of-the-art drug-adhesive matrix transdermal patch, and is being developed for patients with fibromyalgia and peripheral neuropathic pain. THC is a CB1 agonist which acts at many sites along pain transmission pathways, and has been shown to have an analgesic effect in chronic pain models. A pro‑drug is a drug administered in an inactive or less active form and designed to enable more effective delivery, which is then converted into an active form through a normal metabolic process. Transdermal patches allow drugs to be absorbed through the skin directly into the systemic blood circulation, avoiding first-pass liver metabolism and potentially enabling lower dosage levels of active pharmaceutical ingredients, a more controlled, consistent delivery of drug with a higher bioavailability and potentially lower incidence of CNS side effects.

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 March 2017, the Company completed enrollment in 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, the most common form of epilepsy in adults. Also in March 2017, 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 osteoarthritis was fully enrolled. In June 2017, the Company completed target enrollment in its exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial in children with Fragile X syndrome. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical study for ZYN001 was initiated in the second quarter 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. In addition, the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated. 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. 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.

Zynerba Contacts
Jim Fickenscher, CFO and VP Corporate Development
484.581.7483
fickenscherj@zynerba.com

Will Roberts, VP Investor Relations and Corporate Communications
484.581.7489
robertsw@zynerba.com

– Top-line data from this study remains on track to report in September 2017 –

Devon, PA, June 8, 2017 — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative transdermal synthetic cannabinoid treatments, today announced that it has met its enrollment target of 16 patients in its Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial evaluating ZYN002 cannabidiol (CBD) gel in children with Fragile X syndrome (FXS). ZYN002 CBD gel is the first and only patent-protected, synthetic CBD that is formulated as a permeation-enhanced gel for transdermal delivery, and was awarded orphan drug designation by the U.S. Food and Drug Administration for the treatment for FXS.

Patients between the ages of 6 and 17 years with Fragile X syndrome have been enrolled in the exploratory FAB-C trial, which is designed to evaluate the safety and efficacy of ZYN002 CBD gel administered over a 12-week period in FXS. The study is evaluating 50 mg of CBD in ZYN002 4.2% gel once daily, which may be titrated up to 125 mg two times per day during the six-week titration period. Between weeks six and twelve, patients will receive a maintenance dose of 50 mg, 100 mg or 250 mg daily of CBD in ZYN002 4.2% gel. The primary outcome measures include changes in anxiety, depression and mood as measured by the ADAMS scale, a patient reported outcomes questionnaire that has been validated in FXS. Other measurements that are being observed include the Aberrant Behavior Checklist and visual analog scale (VAS) to assess for hyperactivity/impulsivity.

“This achievement marks a key milestone for us and for families facing the challenges of Fragile X syndrome,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “Fragile X is a devastating genetic disorder for patients and their caregivers. We believe that synthetic CBD holds great therapeutic promise in this setting, as it may compensate for the dysregulation of the endocannabinoid pathway, and in doing so may treat many of the associated neurological symptoms. We look forward to reporting data from this trial in September of this year.”

Fragile X syndrome is an autism spectrum disorder and the most common inherited intellectual disability in males and a significant cause of intellectual disability in females. It is caused by a mutation in the Fragile X Mental Retardation gene located on the X chromosome and leads to dysregulation of the endocannabinoid pathway including the reduction in endogenous cannabinoids (2-AG and anandamide). The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities, social anxiety and memory problems. In the US, there are about 71,000 patients suffering with FXS.

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 adult epilepsy patients with focal seizures, in osteoarthritis and in children with FXS. ZYN002 is a clear, permeation-enhanced gel that is designed to provide consistent, controlled drug delivery transdermally with once- or 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 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 March 2017, the Company completed enrollment in 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, the most common form of epilepsy in adults. Also in March 2017, 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 osteoarthritis was fully enrolled. In June 2017, the Company completed target enrollment in its exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial in children with Fragile X syndrome. 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 by the end of 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. In addition, the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated. 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. 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.

Zynerba Contacts
Jim Fickenscher, CFO and VP Corporate Development
484.581.7483
fickenscherj@zynerba.com

Will Roberts, VP Investor Relations and Corporate Communications
484.581.7489
robertsw@zynerba.com

Devon, PA, June 01, 2017 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative transdermal synthetic cannabinoid treatments, today announced that Zynerba’s Chief Financial Officer, Jim Fickenscher will present a company overview at the Jefferies 2017 Global Healthcare Conference on Thursday, June 8 at 1:30 p.m. ET at the Grand Hyatt in New York, NY.

A live webcast of the presentation will be accessible on the Investor Relations page of http://www.zynerba.com. A replay of the webcast will be available for 90 days following the conclusion of the 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 March 2017, the Company completed enrollment in 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, the most common form of epilepsy in adults. Also in March 2017, 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 osteoarthritis was fully enrolled. In December 2016, the Company initiated the exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial in children with Fragile X syndrome (FXS). 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 by the end of the first half of 2017. Learn more at www.zynerba.com and follow the Company on Twitter at @ZynerbaPharma.

Cautionary Statement on Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including the Company’s expectations regarding the completion, timing and size of the option exercise, the Company’s anticipated proceeds therefrom and other statements containing the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend,” “expect” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering, as well as other risks and uncertainties discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date of this press release. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investor Contact
William Roberts, Vice President, Investor Relations and Corporate Communications
Zynerba Pharmaceuticals
484.581.7489
robertsw@zynerba.com

Devon, PA, May 9, 2017 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative transdermal synthetic cannabinoid treatments, today reported financial results for the first quarter ended March 31, 2017 and provided an overview of recent operational highlights.

“This quarter, we were very pleased to have surpassed target enrollment in both the STAR 1 and STOP trials for ZYN002 in adult epilepsy and adult osteoarthritis patients, respectively, which we believe indicates strong patient and physician interest in these indications for ZYN002,” said Armando Anido, Chairman and Chief Executive Officer. “We are swiftly advancing our Phase 2 programs for ZYN002 and expect to announce top-line results for the STAR 1 trial first and then the STOP trial in the July/August timeframe, followed by top-line results from the FAB-C study in pediatric Fragile X syndrome patients later in the third quarter. We have also made important progress toward initiating our Phase 1 program for ZYN001, a pro-drug THC patch, which we expect to start by the end of the second quarter of 2017. Momentum across our pipeline continues to build and we remain poised for a transformational 2017.”

First Quarter 2017 and Recent Highlights

Exceeded Target Enrollment of Phase 2 STAR 1 Clinical Trial for ZYN002 CBD Gel in Adult Epilepsy Patients

A total of 188 patients have been randomized in the Phase 2 STAR 1 double-blind, placebo-controlled clinical trial in adult patients with refractory epilepsy, exceeding the 180-patient enrollment target. Following randomization, patients are dosed with either 195 mg or 390 mg of CBD in ZYN002 4.2% gel or placebo daily for 12 weeks. The primary endpoint of the trial is the median reduction in seizure frequency per 28-day period compared to baseline. The company expects to report top-line data from this trial in July/August 2017.

Enrollment Continues in Phase 2 STAR 2 Open-Label Extension Clinical Trial for ZYN002 CBD Gel in Adult Epilepsy Patients

Patients who complete the STAR 1 trial may elect to enroll into the STAR 2 trial, designed to evaluate long-term safety and tolerability of ZYN002 CBD gel across a range of doses. In the open-label extension study, patients receive a high or low-dose of ZYN002 (390 mg or 195 mg of CBD in ZYN002 4.2% gel, respectively) for up to 52 weeks. Of the 151 patients who have completed the STAR 1 trial through May 8, 2017,147 have enrolled into STAR 2.

Exceeded Target Enrollment of Phase 2 STOP Clinical Trial for ZYN002 CBD Gel in Adult Osteoarthritis Patients

Dosing is ongoing in the randomized, double-blind, placebo-controlled Phase 2 STOP trial in osteoarthritis of the knee. We have exceeded the initial target enrollment of 300 patients with 320 patients randomized into one of three dosing groups. Patients are receiving either 250 mg or 500 mg of CBD in ZYN002 4.2% gel or placebo daily for 12 weeks.  The primary endpoint of the trial is the change from baseline in the weekly mean of the 24-hour average worst pain score at week 12. Top-line results are expected to be released after the STAR 1 Trial results in July/August 2017.

FAB-C Exploratory Phase 2 Clinical Trial of ZYN002 CBD Gel in Pediatric Fragile X Syndrome Patients Remains on Track for Top-line Data in 3Q 2017

The Phase 2 exploratory FAB-C clinical trial is designed to evaluate the safety and efficacy of ZYN002 CBD gel in pediatric patients with Fragile X syndrome (FXS). The primary objective is to assess intra-patient changes in anxiety, depression and mood (as measured by the ADAMS scale) versus baseline. The company is targeting enrollment of 16 patients and expects to announce top-line data from the trial in the third quarter of 2017.

Initiation of Phase 1 Programs for ZYN001 On Track for 1H 2017

By the end of the first half of this year, the company expects to initiate Phase 1 trials of ZYN001, a patent-protected, pro-drug of THC that enables transdermal delivery via a patch. The Phase 1 program will evaluate the safety and tolerability of ZYN001 through single and multiple rising dose trials in normal subjects and patients with fibromyalgia. Pending successful Phase 1 results, a Phase 2 program for ZYN001 in fibromyalgia and neuropathic pain is planned to start in the second half of 2017.

Strengthened Senior Management Team

In March 2017, Ken Jones, CPA was named Corporate Controller of Zynerba.  Mr. Jones brings over 30 years of experience in financial reporting, accounting and tax functions across multiple industries, including a combined 16 years serving as Corporate Controller at Vitae Pharmaceuticals and UbiquiTel, Inc.

In April 2017, Ray Mannion joined Zynerba as Vice President, Manufacturing. Mr. Mannion has spent over 35 years in international manufacturing, operations and engineering in the pharmaceutical, medical devices and electrical connection systems industries with Teva Pharmaceuticals, NuPathe, Puricore, Kensey Nash Corporation, AMP Incorporated and others.

In May 2017, Will Roberts was appointed Vice President, Investor Relations and Corporate Communications at Zynerba. Mr. Roberts is an experienced pharmaceutical executive with 25 years of broad communications and scientific research experience with companies including Adaptimmune Therapeutics, ViroPharma Incorporated and MedImmune, Inc.

Strengthened Balance Sheet with Successful Follow-On Offering Raising $58 Million in Gross Proceeds

In the first quarter of 2017, the company completed a follow-on offering, selling 3,220,000 shares of our common stock at an offering price of $18.00 per share, resulting in gross proceeds of $58.0 million. Net proceeds received after deducting underwriting and commissions and offering expenses were $54.2 million, which Zynerba intends to use for the clinical development of ZYN002 and ZYN001, general research and development, and general corporate purposes.

First Quarter 2017 Financial Results

As of March 31, 2017, cash and cash equivalents were $77.5 million, compared to $31.0 million as of December 31, 2016. Research and development expenses for the first quarter of 2017 were $5.5 million, including stock-based compensation of $0.5 million. General and administrative expenses for the first quarter of 2017 were $2.2 million, including stock-based compensation expense of $0.6 million. Net loss for the first quarter of 2017 was $7.3 million with basic and diluted net loss per share of $0.60.

Financial Outlook

The company believes that the current cash position of $77.5 million is sufficient to develop five Phase 3-ready programs and, assuming support from the FDA to move forward, initiate at least one Phase 3 program and fund operations and capital requirements into 2019.

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 March 2017, the Company completed enrollment in 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, the most common form of epilepsy in adults. Also in March 2017, 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 osteoarthritis was fully enrolled. In December 2016, the Company initiated the exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial in children with Fragile X syndrome (FXS). 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 by the end of 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. In addition, the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated. 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. 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.

ZYNERBA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
				Three months ended
				March 31, 2017				March 31, 2016
Revenue				$	—			$	7,250
Operating expenses:
Research and development					5,491,455				2,568,989
General and administrative					2,211,793				1,680,130
Total operating expenses					7,703,248				4,249,119
Loss from operations					(7,703,248	)			(4,241,869	)
Other income (expense):
Interest income					76,885				12,377
Foreign exchange gain (loss)					367,342				(23,148	)
Total other income (expense)					444,227				(10,771	)
Loss before income taxes					(7,259,021	)			(4,252,640	)
Income tax expense					—				28,734
Net loss				$	(7,259,021	)		$	(4,281,374	)
Net loss per share – basic and diluted				$	(0.60	)		$	(0.49	)
Basic and diluted weighted average shares outstanding					12,067,453				8,823,951
Non-cash stock-based compensation included above:
Research and development				$	541,845			$	248,732
General and administrative					646,854				515,067
Total				$	1,188,699			$	763,799

 

ZYNERBA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
			March 31, 2017				December 31, 2016
Assets
Current assets:
Cash and cash equivalents			$	77,493,189			$	30,965,791
Incentive and tax receivables				3,867,811				3,613,943
Prepaid expenses and other current assets				2,002,966				1,830,958
Total current assets				83,363,966				36,410,692
Property and equipment, net				198,197				143,382
Incentive and tax receivables				1,141,533				—
Other assets				200				200
Total assets			$	84,703,896			$	36,554,274
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable			$	996,866			$	1,848,084
Accrued expenses				5,110,490				4,284,907
Deferred grant revenue				833,975				833,975
Total current liabilities				6,941,331				6,966,966
Stockholders’ equity:
Common stock				13,215				9,995
Additional paid-in capital				130,976,933				75,545,875
Accumulated deficit				(53,227,583	)			(45,968,562	)
Total stockholders’ equity				77,762,565				29,587,308
Total liabilities and stockholders’ equity			$	84,703,896			$	36,554,274

Investor Contacts

Jim Fickenscher, CFO and VP Corporate Development
Zynerba Pharmaceuticals
484.581.7483
fickenscherj@zynerba.com

Will Roberts, VP Investor Relations and Corporate Communications
Zynerba Pharmaceuticals
484.581.7489
robertsw@zynerba.com

Kimberly Minarovich
Argot Partners
212.600.1902
kimberly@argotpartners.com

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

Conference call to be held today at 8:30 am ET

Devon, PA, March 27, 2017 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative transdermal synthetic cannabinoid treatments, today reported financial results for the fourth quarter and year ended December 31, 2016 and provided an overview of recent operational highlights.

“2016 was a year marked by tremendous progress for our lead development candidate, ZYN002 CBD gel, as we initiated Phase 2 trials for epilepsy, osteoarthritis and Fragile X syndrome.  I am pleased that we have completed enrollment in the epilepsy and osteoarthritis trials,” said Armando Anido, Chairman and CEO.  “We enter 2017 with great momentum and expect it to be a transformational year with several key milestones expected in the coming months, including top-line results from the three ZYN002 clinical trials and the commencement of our clinical program for ZYN001, our patent-protected pro-drug of THC in development for the treatment of fibromyalgia and peripheral neuropathic pain.”

Fourth Quarter 2016 and Recent Highlights

Completed Enrollment of Phase 2 STAR 1 Clinical Trial for ZYN002 CBD Gel in Adult Epilepsy Patients

Zynerba has completed enrollment in the Phase 2 STAR 1 randomized, double-blind, placebo-controlled clinical trial in adult patients with refractory epilepsy.  Of the 224 patients that have been screened, 170 patients have been randomized into the trial and there are 19 patients still in the eight-week baseline period.  The Company expects to meet or exceed the 180 patient target for randomization in this trial once all patients have completed the baseline period.  Patients are receiving either 195 mg or 390 mg of CBD in ZYN002 4.2% gel or placebo daily for 12 weeks.  The primary endpoint of the trial is the median reduction in seizure frequency per 28-day period compared to baseline. Top-line results are expected in July/August 2017.

Initiated Phase 2 STAR 2 Open-Label Extension Clinical Trial for ZYN002 CBD Gel in Adult Epilepsy Patients

In November 2016, Zynerba initiated an open-label clinical trial in adult patients with refractory epilepsy who complete the STAR 1 trial. Patients who elect to enroll into the STAR 2 trial 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, and is intended to evaluate how ZYN002 CBD gel is tolerated across a range of doses over long-term use. Of the 110 patients who have completed the STAR 1 trial to date, 106 have enrolled into STAR 2.

Completed Enrollment of Phase 2 STOP Clinical Trial for ZYN002 CBD Gel in Adult Osteoarthritis Patients

Zynerba has completed enrollment in the Phase 2 STOP randomized, double-blind, placebo-controlled clinical trial in osteoarthritis of the knee.   A Total of 320 patients have been randomized which exceeds the 300 patient randomization target for the trial.  Patients are receiving either 250 mg or 500 mg of CBD in ZYN002 4.2% gel or placebo daily for 12 weeks.  The primary endpoint of the trial is the change from baseline in the weekly mean of the 24-hour average worst pain score at week 12.  Top-line results are expected in July/August 2017.

Top-line results for the FAB-C Exploratory Phase 2 Clinical Trial of ZYN002 CBD Gel in Pediatric Fragile X Syndrome Patients Now Expected in Q3 2017

The Phase 2 exploratory clinical trial called FAB-C is designed to evaluate the safety and efficacy of ZYN002 CBD gel in patients between the ages of 8-17 years with Fragile X syndrome (FXS) and is targeting to enroll 16 patients. The complex healthcare needs of children with FXS and the significant impact on families and caregivers have caused delays in patients enrolling into the study. Top-line data are now expected to be available in the third quarter of 2017 rather than the end of the first half of 2017.

Strengthened Balance Sheet with Successful Follow-On Offering Raising $58 Million in Gross Proceeds

In the first quarter of 2017, the Company completed a follow-on offering, selling 3,220,000 shares of our common stock at an offering price of $18.00 per share, resulting in gross proceeds of $58.0 million. Net proceeds received after deducting underwriting and commissions and offering expenses were $54.3 million, which Zynerba intends to use for the clinical development of ZYN002 and ZYN001, general research and development, and general corporate purposes.

Presented Phase 1 Data on ZYN002 CBD Gel at the 70th Annual Meeting of the American Epilepsy Society 

At the 70th Annual Meeting of the American Epilepsy Society held in December, results from a Phase 1 double-blind, placebo-controlled single ascending dose study involving 32 healthy adults were presented in two  posters entitled, “Neuropsychological Effects of ZYN002 (Synthetic Cannabidiol) Transdermal Gel in Healthy Subjects and Patients With Epilepsy: Phase 1, Randomized, Double-Blind, Placebo-Controlled Studies” and “Safety and Tolerability of ZYN002 (Synthetic Cannabidiol) Transdermal Permeation-Enhanced Gel in Healthy Subjects and Patients with Epilepsy:  Three Phase 1, Randomized, Double-Blind, Placebo-Controlled Studies”, which illustrated that ZYN002 CBD gel was safe and well-tolerated at all dose levels ranging from 50 mg to 504 mg and did not produce impairment in critical areas of cognitive function often impacted by medications used to treat central nervous system conditions.

Strengthened Senior Management Team

In December, Marcel Bonn-Miller, PhD, joined Zynerba as Director of Cannabinoid Research. Dr. Bonn-Miller has spent over a decade investigating the interrelations between cannabis and various diseases and disorders.  Dr. Bonn-Miller is a world-renowned expert and has published well over 100 peer-reviewed empirical publications, and he serves on the editorial boards of six scientific journals.

In January 2017, Brian Rosenberger was appointed Vice President, Commercial.  Mr. Rosenberger is an experienced pharmaceutical executive who has held leadership roles in marketing, sales, business development, analytics and alliance management at Cipher Pharmaceuticals, Auxilium Pharmaceuticals, Neurocrine Biosciences and GlaxoSmithKline.

Anticipated 2017 Milestones

ZYN002, a patent-protected, synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery

• ZYN002 is currently being evaluated in three Phase 2 clinical trials in epilepsy patients with focal seizures, in osteoarthritis and in pediatric patients with FXS which has been designated as an Orphan drug by the US FDA. The Company expects to report top-line data for all three trials in 2017.

• Top-line results from the Phase 2 STAR1 clinical trial in adult epilepsy patients with focal seizures and from the Phase 2 STOP clinical trials in patients with knee pain due to osteoarthritis are anticipated in July/August 2017;
• Top-line results from the FAB-C exploratory Phase 2 clinical trial in pediatric patients with Fragile X syndrome are expected in the third quarter of 2017;

ZYN001, a patent-protected, pro-drug of THC that enables transdermal delivery via a patch

• In the first half of 2017, Zynerba expects to initiate Phase 1 studies to evaluate the safety and pharmacokinetic (PK) profile and tolerability of ZYN001 in healthy volunteers
• Zynerba expects to begin two Phase 2 clinical trials for ZYN001 in patients with fibromyalgia and peripheral neuropathic pain in the second half of the year.

Fourth Quarter and Year End 2016 Financial Results 

As of December 31, 2016, cash and cash equivalents totaled $31.0 million, compared to $41.5 million as of December 31, 2015.  During the year ended December 31, 2016, the Company entered into an Open Market Sales Agreement with Jefferies LLC pursuant to which the Company sold and issued 794,906 shares of common stock in the open market at a weighted average selling price of $13.39 per share, for net proceeds of $10.0 million, $5.3 million of which were received and included as cash and cash equivalents as of September 30, 2016.  The remaining $4.7 million in net proceeds were received and included as cash and cash equivalents as of December 31, 2016.

Research and development expenses for the fourth quarter of 2016 were $4.9 million, including stock-based compensation of $0.4 million. General and administrative expenses for the fourth quarter of 2016 were $1.8 million, including stock-based compensation expense of $0.5 million.  Net loss for the fourth quarter of 2016 was $6.9 million with basic and diluted net loss per share of $(0.71).

2017 Financial Outlook

In the first quarter of 2017, the Company completed a follow-on public offering, selling 3,220,000 shares of our common stock at an offering price of $18.00 per share, resulting in gross proceeds of $58.0 million. Net proceeds received after deducting underwriting and commissions and offering expenses were $54.3 million.  Based on Zynerba’s cash position of $31.0 million in cash and cash equivalents at year-end 2016, and including proceeds from the Company’s follow-on public offering in the first quarter of 2017, the Company estimates that this balance is sufficient to develop five Phase 3 ready programs and, assuming feedback from the FDA supports a decision to move forward, initiate at least one Phase 3 program and fund operations and capital requirements into 2019.

Conference Call & Webcast Information

Zynerba management will host a live conference call and webcast today at 8:30 am Eastern Time to discuss the fourth quarter and 2016 financial results as well as operational highlights. The call can be accessed by dialing (844) 815-4960 (U.S. and Canada) or (210) 229-8835 (international) and referencing conference ID 84591304. To access the live webcast or the replay, visit the investor page of the Company’s website at http://ir.zynerba.com/. The webcast will be recorded and available on the Company’s website for 30 days.

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, the most common form of epilepsy in adults. 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 osteoarthritis was initiated. In December 2016, the Company initiated the exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial in children with Fragile X syndrome (FXS). 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 first half of 2017. Learn more at www.zynerba.com and follow the Company on Twitter at @ZynerbaPharma.

Cautionary Note on Froward-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. In addition, the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated. 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. 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.

ZYNERBA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
		Three months ended								Year ended
		December 31, 2016				December 31, 2015				December 31, 2016				December 31, 2015
Revenue		$	–			$	49,275			$	7,250			$	278,900
Operating expenses:
Research and development			4,904,363				3,309,008				16,784,626				7,445,669
General and administrative			1,780,304				2,156,388				6,430,252				5,364,390
Total operating expenses			6,684,667				5,465,396				23,214,878				12,810,059
Loss from operations			(6,684,667	)			(5,416,121	)			(23,207,628	)			(12,531,159	)
Other income (expense):
Interest income			26,980				4,403				80,222				7,352
Foreign exchange loss			(139,829	)			–				(189,497	)			–
Loss on disposal of equipment			(99,147	)			–				(99,147	)			–
Total other income (expense)			(211,996	)			4,403				(208,422	)			7,352
Loss before income taxes			(6,896,663	)			(5,411,718	)			(23,416,050	)			(12,523,807	)
Income tax expense (benefit)			–				27,543				(27,543	)			27,543
Net loss		$	(6,896,663	)		$	(5,439,261	)		$	(23,388,507	)		$	(12,551,350	)
Net loss per share – basic and diluted		$	(0.71	)		$	(0.62	)		$	(2.58	)		$	(2.82	)
Basic and diluted weighted average shares outstanding			9,678,924				8,787,855				9,070,232				4,457,719
Non-cash stock-based compensation included above:
Research and development		$	365,072			$	248,732			$	1,281,108			$	545,901
General and administrative			522,352				515,069				1,988,258				1,054,724
Total		$	887,424			$	763,801			$	3,269,366			$	1,600,625

ZYNERBA PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (Unaudited)
		December 31, 2016				December 31, 2015
Assets
Current assets:
Cash and cash equivalents		$	30,965,791			$	41,513,060
Incentive and tax receivables			3,613,943				356,718
Prepaid expenses and other current assets			1,830,958				1,545,917
Total current assets			36,410,692				43,415,695
Property and equipment, net			143,382				227,646
Other assets			200				200
Total assets		$	36,554,274			$	43,643,541
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable		$	1,848,084			$	823,401
Accrued expenses			4,284,907				2,272,991
Deferred grant revenue			833,975				841,225
Total current liabilities			6,966,966				3,937,617
Stockholders’ equity:
Common stock			9,995				9,200
Additional paid-in capital			75,545,875				62,276,779
Accumulated deficit			(45,968,562	)			(22,580,055	)
Total stockholders’ equity			29,587,308				39,705,924
Total liabilities and stockholders’ equity		$	36,554,274			$	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

Conference Call and Webcast Scheduled for 8:30 AM ET

Devon, PA, March 13, 2017 – 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 report its fourth quarter and full-year 2016 financial results and recent operating progress on Monday, March 27, 2017. Management will host a conference call and webcast at 8:30 am ET.

To participate in the call, please dial (844) 815-4960 (domestic) or (210) 229-8835 (international) and reference conference ID 84591304. A live webcast will be available on the Investor Relations page of the Company’s website, www.zynerba.com, and a replay will be available for 30 days.

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, the most common form of epilepsy in adults. 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 osteoarthritis was initiated. In December 2016, the Company initiated the exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial in children with Fragile X syndrome (FXS). 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 first half of 2017. Learn more at www.zynerba.com and follow the Company on Twitter at @ZynerbaPharma.

Cautionary Statement 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 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Investor Contact
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