New product in development diversifies portfolio to drive long-term growth

Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs

Zygel™ in pivotal Phase 3 trial for Fragile X syndrome and has completed Phase 2 proof-of-concept study in 22q11.2 deletion syndrome


PLYMOUTH MEETING, PA, October 11, 2023 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it has completed its acquisition of Zynerba Pharmaceuticals, Inc. (“Zynerba”) (Nasdaq: ZYNE).

Zynerba is a leader in pharmaceutically produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders. Harmony President & CEO Jeffrey M. Dayno, MD, described its lead candidate, Zygel, as a ‘portfolio in a product’ with the potential to serve 80,000 U.S. patients who are diagnosed with Fragile X syndrome (FXS) and another 80,000 diagnosed with 22q deletion syndrome (22q).

“Zygel is a significant market opportunity that advances our long-term growth strategy of developing a diversified portfolio beyond sleep/wake therapies,” Dayno said. “This acquisition expands our pipeline with a product candidate in our area of expertise that could address high unmet medical needs for people living with rare neuropsychiatric disorders.”

Zygel is the first-and-only pharmaceutically manufactured synthetic cannabidiol. It is a non-euphoric cannabinoid formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. The product is manufactured through a synthetic process in a cGMP facility and is not extracted from the cannabis plant.

Zygel does not contain THC, the compound that causes the euphoric effect of cannabis, and has the potential to be a nonscheduled product if approved.

Cannabidiol, the active ingredient in Zygel, has been granted orphan drug designation by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of FXS and for the treatment of 22q. Additionally, Zygel has received FDA Fast Track designation for the treatment of behavioral symptoms in patients with FXS.

Harmony’s tender offer to acquire all outstanding shares of Zynerba for a purchase price of $1.1059 per share in cash, or $60 million in the aggregate, plus one non-tradeable contingent value right (CVR) per share, representing the right to receive potential additional payments of up to $140 million or approximately $2.5444 in additional cash per share, subject to the achievement of certain clinical, regulatory and sales milestones, expired at 5:00 p.m. New York City time on Tuesday, October 10, 2023. The depositary for the tender offer has advised that, as of the expiration of the tender offer, a total of 28,236,148 shares of Zynerba’s common stock were validly tendered and not withdrawn in the tender offer, which represent approximately 52.3% of the total number of shares of Zynerba’s outstanding common stock (not including 1,072,940 shares delivered through Notices of Guaranteed Delivery, representing approximately 2.0% of the shares outstanding).

Following the acceptance of the tendered shares, Harmony completed the acquisition of Zynerba through the merger of a wholly owned subsidiary of Harmony with and into Zynerba in which each share of Zynerba’s common stock issued and outstanding immediately prior to consummation of the merger (other than shares (a) held in Zynerba’s treasury, (b) owned by Harmony at the time the offer commenced, (c) irrevocably accepted for payment in the tender offer or (d) shares held by Zynerba stockholders who properly demanded appraisal for their shares under Delaware law), including shares granted under Zynerba’s equity compensation arrangements that were not validly tendered in the tender offer, was converted into the right to receive $1.1059 per share in cash plus one CVR. As a result of the merger, Zynerba became a wholly owned subsidiary of Harmony. The common stock of Zynerba will no longer be listed for trading on the Nasdaq Capital Market.

About Harmony Biosciences
At Harmony Biosciences, we specialize in developing and delivering treatments for rare neurological diseases that others often overlook. We believe that where empathy and innovation meet, a better life can begin for people living with neurological diseases. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, PA, our team of experts from a wide variety of disciplines and experiences is driven by our shared conviction that innovative science translates into therapeutic possibilities for our patients, who are at the heart of everything we do. For more information, please visit www.harmonybiosciences.com.

About Fragile X Syndrome
Fragile X syndrome (FXS) is a rare genetic disorder that is the leading known cause of both inherited intellectual disability and autism spectrum disorder, affecting 1 in 3,600 to 4,000 males and 1 in 4,000 to 6,000 females. The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities and behavioral symptoms, such as social avoidance and irritability. There are approximately 80,000 people in the U.S. and approximately 121,000 people in the European Union and UK living with FXS. There is a significant unmet medical need in patients living with FXS as there are currently no FDA approved treatments for this disorder.

FXS is caused by a mutation in FMR1, a gene which modulates a number of systems, including the endocannabinoid system, and most critically, codes for a protein called FMRP. The FMR1 mutation manifests as multiple repeats of a DNA segment, known as the CGG triplet repeat, resulting in deficiency or lack of FMRP. FMRP helps regulate the production of other proteins and plays a role in the development of synapses, which are critical for relaying nerve impulses, and in regulating synaptic plasticity. In people with full mutation of the FMR1 gene, the CGG segment is repeated more than 200 times, and in most cases causes the gene to not function. Methylation of the FMR1 gene also plays a role in determining functionality of the gene. In approximately 60% of patients with FXS, who have complete methylation of the FMR1 gene, no FMRP is produced, resulting in dysregulation of the systems modulated by FMRP.

About 22q11.2 Deletion Syndrome
22q11.2 deletion syndrome (22q) is a disorder caused by a small missing piece of the 22nd chromosome. The deletion occurs near the middle of the chromosome at a location designated q11.2. It is considered a mid-line condition, with physical symptoms including characteristic palate abnormalities, heart defects, immune dysfunction, and esophageal / GI issues, as well as debilitating neuropsychiatric and behavioral symptoms, including anxiety, social withdrawal, ADHD, cognitive impairment and autism spectrum disorder. It is estimated that 22q occurs in one in 4,000 live births, suggesting that there are approximately 80,000 people living with 22q in the U.S. and 129,000 in the European Union and the UK. Patients with 22q deletion syndrome are managed by multidisciplinary care providers, and there are currently no FDA approved treatments for this disorder.

Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements, including as they relate to Harmony and Zynerba, the future development of their technologies and product candidates, including the development of and market opportunities for Zynerba’s technology and product candidates, the future value (if any) of the contingent value rights, Harmony’s strategy, and the anticipated synergies and benefits from the transaction, are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Potential risks, uncertainties and other factors to be considered include, among others, problems may arise in successfully integrating the business and technologies of Harmony and Zynerba, and Harmony may not realize the expected benefits of the transaction; the transaction may involve unexpected costs; the businesses may suffer as a result of uncertainty surrounding the transaction, including difficulties in maintaining relationships with third parties or retaining key employees; and no contingent consideration may become payable. For further discussion of these and other risks and uncertainties, see Harmony’s and Zynerba’s most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission (the “SEC”), including under the headings “Risk Factors.” You are cautioned to not place undue reliance on forward-looking statements, which speak only as of the date of this document. Except as required by law, neither Harmony nor Zynerba is under any duty to update any of the information in this document.

Harmony Biosciences Investor Contact:
Luis Sanay, CFA

Harmony Biosciences Media Contact:
Cate McCanless

Important Information for Zynerba Pharmaceuticals Stockholders to Tender Shares for the Harmony Transaction: Process and Instructions

Devon, PA, October 4, 2023 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today reminds all stockholders, including individual stockholders, to promptly tender their shares into the tender offer (the “Offer”) by Harmony Biosciences Holdings, Inc. (“Harmony”) and its wholly owned subsidiary, Xylophone Acquisition Corp. (“Purchaser”), to purchase all outstanding shares of Zynerba common stock. The Zynerba Board of Directors unanimously recommends that Zynerba stockholders tender their shares pursuant to the Offer.

Key Information to Know

Tender Deadline:

  • Zynerba stockholders must tender their shares by 5:00 p.m., New York City time, on Tuesday, October 10, 2023. Please note that if you hold shares of Zynerba common stock through a broker or other nominee, they may have a processing cutoff that is prior to the tender deadline (e.g., October 5th or 6th), so it is important that you act now if you want to tender your shares.

How to Tender Your Shares:

  • 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 sharesPlease contact your broker or other nominee promptly to allow sufficient time to tender.  Do not wait until the tender deadline to tender your shares as they may not be counted. Please note that, in some cases, your broker’s or other nominee’s processing cutoff date may have changed since the Offer deadline was first announced, so take prompt action today to ensure your shares are properly tendered prior to any applicable processing cutoff.
    • 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 there, you should be directed to someone who can help you.
  • Zynerba stockholders should contact MacKenzie Partners, Inc., toll free by phone at 800-322-2885 or by email to tenderoffer@mackenziepartners.com with any questions or to request assistance with tendering shares.

Why You Should Tender Your Shares:

  • Every share tendered by stockholders is important.
  • If 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.
  • If Zynerba is not acquired by Harmony, there are significant risks associated with Zynerba’s ability to raise the required capital to continue as a standalone company and remain listed on the Nasdaq stock market.

If the Offer is completed, stockholders will receive an up-front purchase price of $1.1059 per share plus one non-tradeable contingent value right (“CVR”) per share representing the right to receive up to an additional approximately $2.5444 per share in cash, without interest and less any applicable tax withholding, upon the achievement of certain clinical and commercial milestones related to Zygel. If all such milestones are achieved, the total consideration payable to stockholders is up to $3.6503 per share in cash when combined with the up-front purchase price. Additional transaction details and the Company’s previous Offer reminder can be found HERE.

Questions About How to Tender Shares:

  • Please contact MacKenzie Partners, Inc., toll free by phone at 800-322-2885 or by email to tenderoffer@mackenziepartners.com. They will be able to walk you through the tender process and assist with any questions.
  • If you hold shares of Zynerba common stock through a broker or nominee, you should contact your broker or nominee as soon as possible to answer your questions and to allow sufficient time to tender.

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 Zynerba’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: Zynerba’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; Zynerba’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; Zynerba’s ability to obtain additional funding to support its clinical development programs; the results, cost and timing of Zynerba’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; clinical results for Zynerba’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; Zynerba’s ability to obtain and maintain regulatory approval for its product candidates, and the labeling under any such approval; Zynerba’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 Zynerba’s product candidates and Zynerba’s ability to commercialize its product candidates; the size and growth potential of the markets for Zynerba’s product candidates, and Zynerba’s ability to service those markets; Zynerba’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of Zynerba’s product candidates; Zynerba’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 condition; 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 Zynerba’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 (the “SEC”) and available at www.sec.gov. Any forward-looking statements that Zynerba makes in this press release speak only as of the date of this press release. Zynerba 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


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