Zynerba Pharmaceuticals Stockholders Reminded to Tender Shares Before 5:00 PM New York City Time, on Tuesday October 10, 2023

Devon, PA, September 29, 2023 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today released the following letter to stockholders concerning the pending tender offer by Harmony Biosciences Holdings, Inc. (“Harmony”).

Fellow Zynerba Pharmaceuticals Stockholders,

We urge you to promptly tender your shares in response to the pending tender offer (the “Offer”) by Harmony and its wholly owned subsidiary, Xylophone Acquisition Corp. (“Purchaser”). As previously disclosed, the Offer is to purchase all of the issued and outstanding shares of the common stock, par value $0.001 per share, of Zynerba Pharmaceuticals, Inc. (“Zynerba”). Harmony is offering an up-front purchase price of $1.1059 per share plus one non-tradable contingent value right (CVR) per share, with each CVR representing the right to receive contingent payments in cash, without interest and less any applicable tax withholding, upon the achievement of certain clinical and commercial milestones related to Zygel, as described in more detail below under “Additional Information”. If all milestones are achieved, the maximum additional payment to shareholders is up to an additional approximately $2.5444 per share in cash, which would result in total consideration of $3.6503 per share in cash when combined with the up-front consideration.

The Offer is conditioned upon, among other things, more than 50% of the outstanding shares of Zynerba common stock being validly tendered and not properly withdrawn prior to the expiration of the Offer. The Offer was initially scheduled to expire at 5:00 p.m. New York City time on September 26, 2023. As of that time, approximately 32.1% of Zynerba’s outstanding shares of common stock was tendered, which was not sufficient to satisfy the minimum tender condition. On September 27, 2023, Harmony announced an extension of the Offer until 5:00 p.m., New York City time, on Tuesday, October 10, 2023, to allow for additional shares to be tendered by stockholders.

I am reaching out to remind you to tender your shares prior to the expiration of the Offer on October 10, 2023If less than a majority of the outstanding shares of Zynerba common stock are tendered, the Offer will not be completed and Zynerba will not be acquired by Harmony. In order to ensure that the minimum tender condition is met and for you to receive payment in connection with the Offer, it is important that you tender your shares regardless of the number of shares you own.

The Zynerba Board unanimously recommends that Zynerba stockholders tender their shares pursuant to the Offer.

What Happens if Stockholders Don’t Tender Their Shares?

The Zynerba Board of Directors believes there are substantial risks to Zynerba remaining an independent company if the Offer is not completed and Zynerba is not acquired by Harmony. As discussed in further detail in the Schedule 14D-9 filed by Zynerba with the Securities and Exchange Commission (the “SEC”) on August 28, 2023, as amended, these risks include:

  • Zynerba Will Require Significant Additional Capital to Continue as a Standalone Company. As a standalone company, Zynerba will need a significant amount of additional capital in the near term to fund ongoing operations and the continued development of Zygel. Given the macro-economic, industry and market conditions negatively impacting valuations of clinical pharmaceutical and biotechnology companies such as Zynerba, Zynerba’s access to additional capital may be very limited in both availability and amount.
    • Any available fundraising transaction could have a highly dilutive effect on Zynerba’s existing stockholders.
  • Zynerba’s Stock Price Could Decline and Zynerba Could Fail to Meet the Continued Listing Requirements of the Nasdaq Stock Market. If the Offer is not completed, the market price of Zynerba’s common stock may decline, particularly to the extent that the current market price reflects a market assumption that the Offer and merger will be completed. While Zynerba is currently in compliance with the continued listing requirements of the Nasdaq Capital Market, a decline in Zynerba’s stock price could cause Zynerba to fail to comply with the $1.00 minimum price requirements of the Nasdaq Capital Market. Previously, in November 2022, Zynerba was notified by Nasdaq of failure to comply with the $1.00 minimum price requirement and was provided until October 30, 2023 (following the grant of an additional compliance period) to regain compliance. Zynerba’s stock price did not increase above the $1.00 threshold until the time of announcement of the Offer and potential acquisition by Harmony. Throughout 2023, Zynerba sought stockholder approval of a reverse stock split to regain compliance with the Nasdaq minimum price requirement and was unable to obtain the required shareholder approval. If the Offer is not completed and Zynerba is unable to maintain the $1.00 minimum price and is unable to obtain stockholder approval of a reverse stock split, Nasdaq may take steps to delist Zynerba’s common stock.

How to Tender Your Shares

1.   Contact your broker. If you hold shares of Zynerba common stock through a broker, dealer, commercial bank, trust company or other nominee, you must instruct such broker or other nominee to tender your shares. Please do so promptly to allow sufficient time to meet any broker processing deadlines before the Offer expiration at 5:00 p.m. New York City time on Tuesday, October 10, 2023. Do not wait until the Offer expires to tender your shares.

Contact Information for Commonly Used Brokers:

  • Call TD Ameritrade at 888-723-8504, option 1
  • Call Fidelity at 800-343-3548
  • Call E-Trade at 1-800-387-2331
  • Contact Robinhood at https://robinhood.com/contact
    • Please include the stock symbol for the offer (ZYNE) and the number of shares you would like to tender.
  • Call Charles Schwab at 1-800-435-4000
  • Call Morgan Stanley at 1-888-454-3965
  • Call JP Morgan at 1-800-935-9935
  • Call Merrill, a Bank of America Company at 1-800-637-7455

If your broker is not listed above, please contact your broker’s customer service department and ask to speak with Corporate Actions. From here, you should be directed to someone who can help you.

2.   Complete and Return any Required Documentation. If you hold your shares directly as the holder of record, complete and sign the Letter of Transmittal (or, in the case of a book-entry transfer, deliver an Agent’s Message in lieu of the Letter of Transmittal) that was provided to you by the depositary and paying agent for the Offer, Equiniti Trust Company, LLC (the “Depositary”), in accordance with the instructions set forth therein and mail or deliver the Letter of Transmittal with any required signature guarantees and all other required documents to the Depositary. These materials must be delivered to the Depositary prior to 5:00 p.m., New York City time, on October 10, 2023.

If you are a holder of shares and you did not receive materials or information regarding the Offer, please contact the information agent for the transaction, MacKenzie Partners, Inc., as soon as possible, toll free by phone at 800-322-2885 or by email to tenderoffer@mackenziepartners.com.

3.   Tender your shares before October 10, 2023. Please act as soon as possible to ensure you can tender your shares on time. If you were unable to previously tender your shares due to processing deadlines from your broker, you may tender your shares during the extension period. Zynerba stockholders who have previously tendered their shares do not need to re-tender their shares or take any other action as a result of the extension of the Offer.

4.   Call the Information Agent for Assistance.   If you have any questions regarding the tender offer or need help in tendering your shares, please call the information agent for the Offer, MacKenzie Partners, Inc., toll free by phone at 800-322-2885 or by email to tenderoffer@mackenziepartners.com.

On behalf of our entire team and the Board of Directors, we strongly support the Offer and the acquisition by Harmony as we believe it is in the best interests of stockholders. We urge our stockholders to take action in support of the merger by October 10, 2023, as outlined above. Thank you for your continued support of Zynerba.

Sincerely,

Armando Anido
Chairman of the Board and Chief Executive Officer

ADDITIONAL INFORMATION

Transaction Details

The Offer is being made pursuant to the Agreement and Plan of Merger, dated August 14, 2023 (as it may be amended or supplemented, the “Merger Agreement”), entered into by Zynerba, Purchaser and Harmony. Under the terms of the definitive agreement, which was unanimously approved by the boards of directors of Harmony and Zynerba, Harmony commenced a tender offer to acquire all outstanding shares of Zynerba for a purchase price of $1.1059 in cash per share, or $60 million in the aggregate, payable at closing of the transaction plus one non-tradeable CVR representing the right to receive potential additional payments of up to $140 million or approximately $2.5444 in additional cash per share, for a total potential consideration of up to $200 million in cash. The CVR is payable subject to certain terms and conditions upon achievement of the following milestones:

Clinical Milestones

  • Completion of Fragile X syndrome (FXS) Phase 3 clinical trial: $15 million in the aggregate or approximately $0.2747 per share
  • Positive data readout from FXS Phase 3 clinical trial:
    • $30 million in the aggregate or approximately $0.5494 per share if completed on or before December 31, 2024
    • $20 million in the aggregate or approximately $0.3663 per share if completed on or before June 30, 2025
    • $10 million in the aggregate or approximately $0.1831 per share if completed after June 30, 2025

Regulatory Milestones

  • U.S. Food and Drug Administration (FDA) approval in FXS: $35 million in the aggregate or approximately $0.6389 per share
  • FDA approval in Second Indication: $15 million in the aggregate or approximately $0.2707 per share

Net Sales Milestones

  • Achievement of $250 million in aggregate Net Sales: $15 million in the aggregate or approximately $0.2702 per share
  • Achievement of $500 million in aggregate Net Sales: $30 million in the aggregate or approximately $0.5405 per share

Each CVR is subject to the achievement of the milestone conditions described above, and there can be no assurance whether any such milestones will be achieved or when any payments will be made with respect to any CVR.

The Zynerba Board of Directors, after considerable deliberation and discussion, unanimously recommends that Zynerba stockholders accept the Offer and tender their shares of Zynerba common stock to Purchaser pursuant to the Offer. A complete description of the reasons of the Zynerba Board of Directors for authorizing and approving the Merger Agreement and the transactions contemplated thereby, including the Offer, is set forth in the Schedule 14D-9 filed by Zynerba with the SEC on August 28, 2023, as amended.

The Offer is conditioned upon, among other things, more than 50% of the outstanding shares of Zynerba common stock being validly tendered and not properly withdrawn prior to the expiration of the Offer. In order to ensure that this condition is met and, thereby, for you to receive payment in connection with the Offer, it is important that you tender your shares regardless of the number of shares you own. A complete description of the Offer is set forth in the Schedule TO filed by Harmony and Purchaser on August 28, 2023, as amended. If less than 50% of the outstanding shares of Zynerba common stock are tendered, the Offer will not be completed and Zynerba will not be acquired by Harmony.

For more information, please refer to the sections entitled “Background of the Merger” and “Reasons for the Recommendation” set forth in the Schedule 14D-9 filed by Zynerba with the SEC on August 28, 2023, as amended.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals is the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X syndrome and 22q11.2 deletion syndrome. Learn more at www.zynerba.com and follow us on Twitter at @ZynerbaPharma.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, incentive and other tax credit eligibility, collectability and timing, and availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its clinical development programs; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; clinical results for the Company’s product candidates may not be replicated or continue to occur in additional trials and may not otherwise support further development in a specified indication or at all; actions or advice of the U.S. Food and Drug Administration, the European Medicines Agency and other foreign regulatory agencies may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company’s ability to obtain and maintain regulatory approval for its product candidates, and the labeling under any such approval; the Company’s reliance on third parties to assist in conducting pre-clinical and clinical trials for its product candidates; delays, interruptions or failures in the manufacture and supply of the Company’s product candidates the Company’s ability to commercialize its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates; the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates; the extent to which health epidemics and other outbreaks of communicable diseases, including COVID-19, could disrupt our operations or adversely affect our business and financial conditions; and the extent to which inflation, banking stability or global instability, including political instability, may disrupt our business operations or our financial condition. 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.

Additional Information about the Acquisition and Where to Find It
This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Zynerba, nor is it a substitute for the tender offer materials that Harmony and Purchaser filed with the SEC upon commencement of the tender offer. Harmony and Purchaser initially filed tender offer materials on Schedule TO on August 28, 2023, and Zynerba initially filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer on August 28, 2023. Holders of shares of Zynerba common stock are urged to read the tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement (as each may be amended or supplemented from time to time) because they contain important information that holders of shares of Zynerba common stock should consider before making any decision regarding tendering their shares. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, have been available to all holders of shares of Zynerba at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement are available for free at the SEC’s website at www.sec.gov. In addition, these materials are available at no charge on the Enhanced SEC Filings section of the Investor Relations page of Zynerba’s website at https://www.zynerba.com/ and by directing a request to the information agent for the tender offer, MacKenzie Partners, Inc., who can be reached toll free by phone at 800-322-2885 or by email to tenderoffer@mackenziepartners.com.

Zynerba Contacts
Peter Vozzo
ICR Westwicke
Office: 443.213.0505
Cell: 443.377.4767
Peter.Vozzo@Westwicke.com

 

Zynerba Pharmaceuticals Reports Third Quarter 2018 Financial Results and Operational Highlights

Devon, PA, November 8, 2018 — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today reported financial results for the third quarter ended September 30, 2018 and provided an overview of recent operational highlights.

“The momentum we established in the first half of 2018 continued through the third quarter,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We began enrolling patients into CONNECT-FX, our pivotal study in Fragile X syndrome and we expect to complete enrollment in BELIEVE-1, our Phase 2 study in developmental and epileptic encephalopathies, before year end. With our third quarter 2018 follow-on offering, we are well capitalized and expect our current cash to take us through the presentation of top line data for both of these studies.”

Third Quarter 2018 and Recent Highlights

ZYN002 in Fragile X Syndrome (FXS)

Initiated CONNECT-FX, a Pivotal Clinical Trial of ZYN002 in FXS

Enrollment is progressing in CONNECT-FX (Clinical study of Cannabidiol (CBD) in Children and Adolescents with Fragile X), a pivotal, multi-national, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of ZYN002 in three to 17-year old FXS patients with full mutation of the FMR1 gene. The primary endpoint is the change from baseline to the end of the treatment period in the Aberrant Behavior Checklist-Community FXS Specific (ABC-CFXS) Social Avoidance subscale. Top line data are expected in the second half of 2019; there are currently no approved products indicated for FXS.

Presented New Data at the 16th NFXF International Fragile X Conference from the Ongoing Open Label FAB-C Phase 2 Study of ZYN002

Zynerba presented new data demonstrating that treatment with ZYN002 improved core behavioral symptoms of FXS with statistical significance versus baseline across multiple measures of efficacy at week 12, and these improvements were sustained through 38 weeks of treatment. For example, significant improvements vs. baseline in social avoidance as measured by the ABC-CFXS were demonstrated at 12 weeks (58%; p=0.0040) and 38 weeks (75%; p=0.0013) of treatment with ZYN002.

Poster Accepted for Presentation at the 57th Annual Meeting of the American College of Neuropsychopharmacology (ACNP)

The poster presentation is on Wednesday, December 12, 2018 in poster session III from 5:30 PM to 7:30 PM EST. The meeting will be at the Diplomat Beach Resort in Hollywood, Florida from December 9 through 12, 2018.

ZYN002 in Developmental and Epileptic Encephalopathies (DEE)

Enrollment Nearing Completion in the Phase 2 BELIEVE 1 Clinical Trial in DEE; Topline Results Expected in 2019

Enrollment is progressing in BELIEVE 1 (Open Label Study to Assess the Safety and Efficacy of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Developmental and Epileptic Encephalopathy). This is a six-month multi-dose Phase 2 clinical trial evaluating the efficacy and safety of ZYN002 in approximately 50 children and adolescents with DEE, a category of epilepsy syndromes that involve significant developmental impairment or regression of developmental progress, and are highly resistant to treatment. The Company expects to complete enrollment by year-end 2018.

ZYN002 in Focal Epilepsy

STAR-2 Long-Term Data Accepted for Poster Presentation at the 2018 Annual Meeting of the American Epilepsy Society (AES)

The poster presentation is on Sunday, December 2, 2018 in poster session 2 from 12:00 PM to 2:00 PM EST. The meeting will be at the Ernest N. Morial Convention Center in New Orleans, LA from November 30 to December 4, 2018. The poster will highlight efficacy and safety data from adult patients with refractory focal epilepsy receiving treatment with ZYN002 for up to 18 months. These data contribute to the design of the upcoming double blind, placebo-controlled Phase 2b study, which the Company expects to initiate in the fourth quarter of 2018.

Corporate

Completed Successful $30 Million Follow-on Offering

The Company improved its capital structure through a completed follow-on offering, resulting in net proceeds of $29.9 million after deducting underwriting discounts and commissions and offering expenses.

Third Quarter 2018 Financial Results

As of September 30, 2018, cash and cash equivalents were $66.2 million, compared to $62.5 million as of December 31, 2017. Research and development expenses for the third quarter of 2018 were $4.9 million, including stock-based compensation of $0.7 million. General and administrative expenses for the third quarter of 2018 were $3.1 million, including stock-based compensation expense of $0.8 million. Net loss for the third quarter of 2018 was $7.8 millionwith basic and diluted net loss per share of $(0.47).

Financial Outlook
The Company’s cash and cash equivalent position as of September 30, 2018 was $66.2 million, which management believes is sufficient to fund operations and capital requirements into the first half of 2020.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals is the leader in pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X syndrome and refractory epilepsies. Learn more at www.zynerba.com and follow us on Twitter at @ZynerbaPharma

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s ability to obtain additional funding to support its clinical development programs; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; clinical results for the Company’s product candidates may not be replicated or continue to occur in additional trials and may not otherwise support further development in a specified indication or at all; actions or advice of the U.S. Food and Drug Administration and foreign regulatory agencies may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company’s ability to obtain and maintain regulatory approval for its product candidates, and the labeling under any such approval; the Company’s reliance on third parties to assist in conducting pre-clinical and clinical trials for its product candidates; delays, interruptions or failures in the manufacture and supply of the Company’s product candidates the Company’s ability to commercialize its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates; and the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates. This list is not exhaustive and these and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

ZYNERBA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
 
Three months ended September 30,  Nine months ended September 30, 
2018   2017 2018   2017
Operating expenses:
Research and development $   4,859,902 $   5,753,764 $   22,368,881 $   16,978,016
General and administrative   3,125,780   2,795,839   9,982,743   7,640,489
Total operating expenses   7,985,682   8,549,603   32,351,624   24,618,505
Loss from operations   (7,985,682 )   (8,549,603 )   (32,351,624 )   (24,618,505 )
Other income (expense):
Interest income   278,214   161,930   639,702   363,350
Foreign exchange (loss) gain   (99,897 )   76,468   (409,010 )   361,450
Total other income (expense)   178,317   238,398   230,692   724,800
Net loss $   (7,807,365 ) $   (8,311,205 ) $   (32,120,932 ) $   (23,893,705 )
Net loss per share – basic and diluted $   (0.47 ) $   (0.63 ) $   (2.21 ) $   (1.87 )
Basic and diluted weighted average shares outstanding   16,587,353   13,098,914   14,531,272   12,743,332
Non-cash stock-based compensation included above:
Research and development $   743,153 $   591,898 $   2,267,783 $   1,722,456
General and administrative   841,077   1,130,745   2,759,330   2,544,260
Total $   1,584,230 $   1,722,643 $   5,027,113 $   4,266,716

 

ZYNERBA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(unaudited)
September 30, 2018   December 31, 2017
Assets
Current assets:
Cash and cash equivalents $   66,177,376 $   62,510,277
Incentive and tax receivables   3,095,195   3,983,604
Prepaid expenses and other current assets   3,413,029   1,733,701
Total current assets   72,685,600   68,227,582
Property and equipment, net   248,741   164,527
Other assets   —   662,200
Total assets $   72,934,341 $   69,054,309
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $   3,553,350 $   3,355,255
Accrued expenses   5,415,742   3,915,491
Deferred grant revenue   171,975   171,975
Total current liabilities   9,141,067   7,442,721
Deferred grant revenue, long-term   —   662,000
Total liabilities   9,141,067   8,104,721
Stockholders’ equity:
Common stock   17,623   13,554
Additional paid-in capital   173,877,449   138,916,900
Accumulated deficit   (110,101,798 )   (77,980,866 )
Total stockholders’ equity   63,793,274   60,949,588
Total liabilities and stockholders’ equity $   72,934,341 $   69,054,309


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

Zynerba Pharmaceuticals Announces Initiation of STAR 2 Open-Label Extension Clinical Trial for ZYN002 CBD Gel in Adult Refractory Epilepsy Patients

Devon, PA, November 2,  2016  — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced the enrollment of the first patients into the STAR 2 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial, an open-label extension trial which allows patients who have completed  the STAR 1 clinical trial to receive treatment with ZYN002 CBD gel for up to 52 weeks.

“STAR 2 is designed to provide additional tolerability and safety information for ZYN002 CBD gel for up to 52 weeks, which we believe will establish that ZYN002 CBD gel is well-tolerated over long-term use,” said Armando Anido, CEO of Zynerba. “Enrollment in STAR 1 is continuing and we plan to report top line results in the first half of 2017.”

STAR 2 is a multi-center, open-label Phase 2 clinical trial in which epilepsy patients with refractory focal seizures who complete the STAR 1 study will receive treatment with ZYN002 for up to 52 weeks.  The patients will receive 195 mg of CBD in ZYN002 4.2% gel every 12 hours. After two weeks, the investigators will have the option to reduce the dose to 97.5 mg of CBD in ZYN002 4.2% gel every 12 hours based upon the patient’s response.  The clinical trial is being conducted at the same 14 sites in Australia and New Zealand as the STAR 1 clinical trial.

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 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 by year-end 2016. Top line results from all three Phase 2 clinical trials are planned to report in the first half of 2017. 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 Contact
Eliza Schleifstein
Argot Partners
973.361.1546
eliza@argotpartners.com

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