0001104659-21-142213.txt : 20211122 0001104659-21-142213.hdr.sgml : 20211122 20211122072320 ACCESSION NUMBER: 0001104659-21-142213 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20211122 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20211122 DATE AS OF CHANGE: 20211122 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Zynerba Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001621443 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 260389433 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37526 FILM NUMBER: 211430145 BUSINESS ADDRESS: STREET 1: 80 W. LANCASTER AVENUE STREET 2: SUITE 300 CITY: DEVON STATE: PA ZIP: 19333 BUSINESS PHONE: 484-581-7505 MAIL ADDRESS: STREET 1: 80 W. LANCASTER AVENUE STREET 2: SUITE 300 CITY: DEVON STATE: PA ZIP: 19333 FORMER COMPANY: FORMER CONFORMED NAME: Zynerba Pharmeceuticals, Inc. DATE OF NAME CHANGE: 20141003 8-K 1 tm2132711d2_8k.htm FORM 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15 (d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): November 22, 2021

 

 

 

ZYNERBA PHARMACEUTICALS, INC.

(Exact Name of Issuer as Specified in Charter)

 

 

 

Delaware   001-37526   26-0389433
(State or Other Jurisdiction of
Incorporation or Organization)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)

 

80 W. Lancaster Avenue, Suite 300

Devon, PA 19333

(Address of Principal Executive Offices)

 

(484) 581-7505

(Registrant’s Telephone Number, Including Area Code)

 

 

 

Check the appropriate box below if the Form 8–K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a–12 under the Exchange Act (17 CFR 240.14a–12)

 

¨ Pre–commencement communications pursuant to Rule 14d–2(b) under the Exchange Act (17 CFR 240.14d–2(b))

 

¨ Pre–commencement communications pursuant to Rule 13e–4(c) under the Exchange Act (17 CFR 240.13e–4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, $0.001 par value per share   ZYNE   The Nasdaq Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 8.01Other Events

 

On November 22, 2021 Zynerba Pharmaceuticals, Inc. issued a press release announcing that the European Patent Office has issued Patent No. 3687513, titled “Treatment of Fragile X Syndrome and Autism with Cannabidiol,” which includes claims directed to methods of treating one or more behavioral symptoms of Fragile X syndrome and methods of treating one or more behavioral symptoms of autism spectrum disorder by transdermally administering a therapeutically effective amount of cannabidiol (CBD). A copy of this press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

Item 9.01Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit
No.
  Document
     
99.1   Press Release dated November 22, 2021
104   The cover page from this Current Report on Form 8-K, formatted in Inline XBRL

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: November 22, 2021

 

  ZYNERBA PHARMACEUTICALS, INC.
   
  By: /s/ Suzanne Hanlon
    Name: Suzanne Hanlon
    Title: Secretary, Vice President and General Counsel

 

 

 

EX-99.1 2 tm2132711d2_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

Zynerba Pharmaceuticals Announces Issuance of New Patent in EU for Zygel™

 

DEVON, Pa., November 22, 2021 – Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that the European Patent Office has issued Patent No. 3687513, titled “Treatment of Fragile X Syndrome and Autism with Cannabidiol,” which includes claims directed to methods of treating one or more behavioral symptoms of Fragile X syndrome and methods of treating one or more behavioral symptoms of autism spectrum disorder by transdermally administering a therapeutically effective amount of cannabidiol (CBD).

 

This new patent, which expires in 2038, is part of an expanding international intellectual property portfolio covering the Company's transdermal cannabidiol product candidate, Zygel™ CBD gel. There are currently five corresponding U.S. patents related to methods of treating Fragile X syndrome or autism spectrum disorder.

 

About Zynerba Pharmaceuticals, Inc.

 

Zynerba Pharmaceuticals is the leader in innovative 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, autism spectrum disorder, 22q11.2 deletion syndrome, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies. Learn more at www.zynerba.com and follow us on Twitter at @ZynerbaPharma.

 

1 

 

 

 

 

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 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; the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates; the timing and outcome of current and future legal proceedings; and 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. 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.

 

Investor Contact

 

Peter Vozzo

ICR Westwicke

Office: 443.213.0505

Cell: 443.377.4767

Peter.Vozzo@Westwicke.com

 

2

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Cover
Nov. 22, 2021
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 22, 2021
Entity File Number 001-37526
Entity Registrant Name ZYNERBA PHARMACEUTICALS, INC.
Entity Central Index Key 0001621443
Entity Tax Identification Number 26-0389433
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 80 W. Lancaster Avenue
Entity Address, Address Line Two Suite 300
Entity Address, City or Town Devon
Entity Address, State or Province PA
Entity Address, Postal Zip Code 19333
City Area Code 484
Local Phone Number 581-7505
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.001 par value per share
Trading Symbol ZYNE
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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