Zynerba Pharmaceuticals Reports Second Quarter 2022 Financial Results and Operational Highlights

Enrollment continues in RECONNECT, a confirmatory pivotal Phase 3 trial of Zygel™ in patients with Fragile X syndrome (FXS); topline results expected second-half 2023

Announced positive topline results from Phase 2 trial of Zygel in patients with 22q11.2 deletion syndrome (22q)

Company focusing resources on orphan neuropsychiatric disorders, FXS and 22q

$62.5 million in cash and cash equivalents at June 30, 2022; Cash runway through the end of 2023 / early 2024

Devon, PA, August 10, 2022 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today reported financial results for the second quarter ended June 30, 2022, and provided an overview of recent operational highlights and a pipeline update.

“During the second quarter, we were pleased to announce positive topline results from our Phase 2 trial of Zygel in patients with 22q. In addition to further progressing 22q, we are focused on completing the Phase 3 RECONNECT trial for children and adolescents with Fragile X syndrome, with topline results expected in the second half of 2023,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “With a cash runway extending past expected availability of topline results from our RECONNECT trial, we remain well-positioned on achieving our goal of bringing the first pharmaceutical product indicated for the treatment of behavioral symptoms of Fragile X syndrome to market.”

Operational Highlights and Pipeline Update

Zygel in Fragile X Syndrome (FXS)

  • The Company continues to expect topline results from RECONNECT, a confirmatory pivotal Phase 3 trial of Zygel in patients with FXS, in the second half of 2023. The Company believes that the results from RECONNECT, if positive, will be sufficient to support the submission of a New Drug Application (NDA) for Zygel in patients with FXS.

  • Presented data at the 18th NFXF International Fragile X Conference in July and the American Society of Clinical Psychopharmacology Annual Meeting in June demonstrating that in the long-term safety and efficacy study of Zygel in children and adolescents with FXS, improvement was seen in Social Avoidance in the full population, with the greatest improvement in patients with complete methylation of the FMR1 gene. Patients with complete methylation, who match the primary efficacy population in the ongoing confirmatory trial, RECONNECT, achieved and maintained clinically meaningful change in Social Avoidance, supporting one of the key design enhancements for RECONNECT. Zygel was well-tolerated during long-term administration up to 38 months of exposure. (Poster and Presentation)

  • Presented data at the 18th NFXF International Fragile X Conference in July and the American Society of Clinical Psychopharmacology Annual Meeting in June describing how learnings from CONNECT-FX, the first randomized, double-blind, placebo-controlled trial of Zygel in the treatment of FXS, shaped the design of RECONNECT. In addition to the primary endpoint of the RECONNECT trial being measured in patients who have a completely methylated FMR1 gene, the treatment period of the trial has been extended by four weeks and an additional weight-based dose has been added for participants weighing greater than 50kg. RECONNECT is expected to provide key data to determine the effectiveness of Zygel in FXS while using a design intended to reduce the burden of participation in a clinical trial for families with children and adolescents with FXS. (Poster)

Zygel in 22q11.2 Deletion Syndrome (22q)

  • In June, the Company announced positive topline results from the exploratory, open label Phase 2 INSPIRE trial of Zygel in children and adolescents with 22q. The INSPIRE trial achieved statistically significant and clinically meaningful improvements from baseline in multiple efficacy assessments. Zygel was shown to be well tolerated, and the safety profile was consistent with previously released data from other Zygel clinical trials. (Press Release)

  • Based on the positive Phase 2 data, the Company plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the data and the regulatory path forward. The Company plans to move forward in 22q as an orphan indication and has previously received orphan drug designation from the FDA for cannabidiol, the active ingredient in Zygel, for the treatment of 22q.

Zygel in Autism Spectrum Disorder (ASD)

  • As previously disclosed, while data from the Company’s ASD clinical development program to date are compelling, given the difficult financing market, the Company has deferred the start of the Phase 3 development program in ASD as it has prioritized its resources on FXS and 22q in the near term.

Second Quarter 2022 Financial Results
Research and development expenses were $5.4 million for the second quarter of 2022, including stock-based compensation of $0.5 million. General and administrative expenses were $3.7 million in the second quarter of 2022, including stock-based compensation expense of $0.6 million. Net loss for the second quarter of 2022 was $9.9 million, with basic and diluted loss per share of $(0.24).

Financial Outlook
As of June 30, 2022, cash and cash equivalents were $62.5 million, compared to $67.8 million as of December 31, 2021.

On May 11, 2021, the Company entered into a Controlled Equity OfferingSM Sales Agreement, or the 2021 Sales Agreement”, with Cantor Fitzgerald & Co., Canaccord Genuity, LLC, H.C. Wainwright & Co. LLC and Ladenburg Thalmann & Co. Inc., as sales agents, pursuant to which the Company may sell, from time to time, up to $75.0 million of its common stock. In the second quarter of 2022, the Company sold and issued 488,892 shares of its common stock under the 2021 Sales Agreement in the open market resulting in gross proceeds of $0.9 million and net proceeds of $0.8 million, after deducting commissions and offering expenses. From July 1, 2022 through August 8, 2022, the Company sold and issued 1,469,714 shares of its common stock under the 2021 Sales Agreement in the open market resulting in gross proceeds of $1.8 million, and net proceeds of $1.6 after deducting commissions and offering expenses

On July 21, 2022, the Company entered into an equity purchase agreement for up to $20 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. Under the terms of the agreement, Zynerba will have the right in its sole discretion, but not the obligation, to sell to LPC shares of its common stock over the 36-month term of the agreement. Zynerba controls the timing and amount of any future sales of its shares of common stock and LPC is obligated to make purchases in accordance with the terms of the purchase agreement, subject to various limitations including those under the Nasdaq listing rules.

Management believes that the Company’s cash and cash equivalents are sufficient to fund operations and capital requirements through the end of 2023 or into early 2024, after the expected availability of topline results from its confirmatory pivotal Phase 3 RECONNECT trial of Zygel in patients with FXS.

About Zygel
Zygel is the first and only pharmaceutically-manufactured cannabidiol formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled drug delivery into the bloodstream transdermally (i.e. through the skin). Recent studies suggest that cannabidiol may modulate the endocannabinoid system and improve certain behavioral symptoms associated with neuropsychiatric conditions. Zygel is an investigational drug product in development for the potential treatment of behavioral symptoms associated with Fragile X syndrome (FXS), 22q11.2 deletion syndrome (22q) and autism spectrum disorder (ASD). The Company has received orphan drug designation for cannabidiol, the active ingredient in Zygel, from the FDA and the European Commission in the treatment of FXS and by the FDA for the treatment of 22q. Additionally, Zygel has been designated a Fast Track development program for treatment of behavioral symptoms of FXS.

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, 22q11.2 deletion syndrome and autism spectrum disorder. 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 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 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 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.

 
ZYNERBA PHARMACEUTICALS, INC.
 
CONSOLIDATED STATEMENTS OF OPERATIONS
     
    (unaudited)
    Three months ended June 30,   Six month ended June 30,
      2022       2021       2022       2021  
Operating expenses:                
Research and development   $ 5,446,317     $ 5,451,948     $ 10,592,922     $ 10,060,958  
General and administrative     3,722,453       4,386,546       7,479,763       7,662,343  
Total operating expenses     9,168,770       9,838,494       18,072,685       17,723,301  
Loss from operations     (9,168,770 )     (9,838,494 )     (18,072,685 )     (17,723,301 )
Other income (expense):                
Interest income     91,691       5,943       187,735       11,576  
Foreign exchange gain (loss)     (775,927 )     (117,528 )     (458,675 )     (199,982 )
Total other income (expense)     (684,236 )     (111,585 )     (270,940 )     (188,406 )
Net loss   $ (9,853,006 )   $ (9,950,079 )   $ (18,343,625 )   $ (17,911,707 )
                 
Net loss per share – basic and diluted   $ (0.24 )   $ (0.25 )   $ (0.45 )   $ (0.47 )
                 
Basic and diluted weighted average shares outstanding     41,406,803       40,065,715       40,858,688       38,344,145  
                 
Non-cash stock-based compensation included above:                
Research and development   $ 488,645     $ 1,005,886     $ 1,018,141     $ 1,625,277  
General and administrative     619,898       928,463       1,250,884       1,573,909  
Total   $ 1,108,543     $ 1,934,349     $ 2,269,025     $ 3,199,186  
                 
ZYNERBA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
         
    (unaudited)    
    June 30, 2022   December 31, 2021
Assets        
Current assets:        
Cash and cash equivalents   $ 62,489,635     $ 67,808,000  
Incentive and tax receivables     1,474,328       9,580,468  
Prepaid expenses and other current assets     1,707,738       2,831,392  
Total current assets     65,671,701       80,219,860  
Property and equipment, net     322,713       385,833  
Incentive and tax receivables     560,745        
Right-of-use assets     451,800       565,814  
Total assets   $ 67,006,959     $ 81,171,507  
Liabilities and Stockholders’ Equity        
Current liabilities:        
Accounts payable   $ 1,674,841     $ 1,798,813  
Accrued expenses     7,640,866       7,896,598  
Lease liabilities     211,965       209,068  
Total current liabilities     9,527,672       9,904,479  
Lease liabilities, long-term     237,414       353,694  
Total liabilities     9,765,086       10,258,173  
         
Stockholders’ equity:        
Common stock     43,936       41,218  
Additional paid-in capital     315,023,041       310,353,595  
Accumulated deficit     (257,825,104 )     (239,481,479 )
Total stockholders’ equity     57,241,873       70,913,334  
Total liabilities and stockholders’ equity   $ 67,006,959     $ 81,171,507  
         

 

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

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

Zynerba Pharmaceuticals to Present In Person at the Canaccord Genuity 42nd Annual Growth Conference

Devon, PA, August 3, 2022 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today announced that Armando Anido, Chairman and Chief Executive Officer of Zynerba Pharmaceuticals, will present an overview and update of the Company at the Canaccord Genuity 42nd Annual Growth Conference on Wednesday, August 10, 2022 at 9:00 a.m. ET at the InterContinental Boston in Boston, Mass.

Investors interested in arranging an in-person meeting with the Company’s management during the conference should contact the Canaccord Genuity conference coordinator. An archived webcast of the presentation will be available on-demand for 60 days following the event under the Events & Webcasts tab of the Investors section of the Zynerba website at www.zynerba.com.

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, 22q11.2 deletion syndrome and autism spectrum disorder. 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 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.

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

Zynerba Pharmaceuticals Enters Into Equity Purchase Agreement for Up to $20 Million with Lincoln Park Capital

Devon, PA, July 21, 2022 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today announced it has entered into an equity purchase agreement for up to $20 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor.

Under the terms of the agreement, Zynerba will have the right in its sole discretion, but not the obligation, to sell to LPC up to $20 million worth of shares of its common stock over the 36-month term of the agreement. Zynerba controls the timing and amount of any future sales of its shares of common stock and LPC is obligated to make purchases in accordance with the terms of the purchase agreement, subject to various limitations including those under the Nasdaq listing rules. Any common stock that is sold by Zynerba will occur at a purchase price that is based on the market prices prevailing at the time of each sale to LPC. There is no upper limit to the price per share that LPC may pay for future stock issuances under the purchase agreement, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Zynerba’s common stock. No warrants are being issued in this transaction and the purchase agreement does not contain any rights of first refusal, participation rights, penalties or liquidated damages provisions in favor of any party. Zynerba may terminate the purchase agreement at any time, at its sole discretion, without any cost or penalty.

The Company expects this commitment from LPC will provide financial flexibility and is aligned with Zynerba’s long-term strategy for value creation. Zynerba intends to use any net proceeds from the sale of its common stock to LPC for working capital and general corporate purposes, including research and development expenses and capital expenditures.

“We are excited to enter into this transaction with Lincoln Park Capital and believe that this agreement provides us with another opportunity to access capital in an efficient manner,” said Jim Fickenscher, Chief Financial Officer and Vice President, Corporate Development of Zynerba. “The financial flexibility provided by this agreement will further support our clinical development efforts with Zygel in Fragile X syndrome and 22q11.2 deletion syndrome.”

Additional information regarding the purchase agreement is set forth in a Current Report on Form 8-K, which Zynerba filed today with the Securities and Exchange Commission.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The offering can be made only by means of the prospectus supplement and accompanying prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov or by request from Zynerba Pharmaceuticals at 80 W. Lancaster Avenue, Suite 300, Devon, Pennsylvania 19333 or by telephone at (484) 581-7505.

Financial Outlook
The Company believes its $69.7 million of cash and cash equivalents as of March 31, 2022 are sufficient to fund planned operations and capital requirements through the end of 2023 or into early 2024, after the expected availability of top line results from its confirmatory Pivotal Phase 3 RECONNECT trial of Zygel in patients with Fragile X syndrome.

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, 22q11.2 deletion syndrome and autism spectrum disorder. 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 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.

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

Zynerba Pharmaceuticals Announces Panel Presentation and Poster Presentations at the NFXF International Fragile X Conference

Devon, PA, July 7, 2022 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced two poster presentations at the 18th NFXF International Fragile X Conference, being held July 14-17, 2022, in San Diego, Calif. In addition, Zynerba management will present a company presentation during the conference’s Keynote – Industry Updates session. Copies of the presentation and posters will be made available on the Zynerba corporate website following the presentations at www.zynerba.com/publications.

Corporate Presentation Details

Title:    Zynerba Pharmaceuticals – Development of ZYN002 (Zygel™) for the Treatment of Behavioral Symptoms in Fragile X Syndrome: Partnering to advance the care of children and adolescents with Fragile X Syndrome
     
Date:   Friday, July 15, 2022
     
Time:   3:15 p.m. – 4:30 p.m. PT (6:15 – 7:30 p.m. ET)
     
Location:   Town and Country – A, Town and Country Resort, San Diego, Calif.

Poster Presentation Details

Title:   Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel
in Children and Adolescents With Fragile X Syndrome (ZYN2-CL-017)
     
Title:   RECONNECT (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Fragile X Syndrome Based Upon Learnings From CONNECT-FX (ZYN2-CL-016)
     
Date:   Friday, July 15, 2022
     
Time:   4:30 p.m. – 7:00 p.m. PT (7:30 – 10:30 p.m. ET)
     
Location:   Town and Country Foyer, Town and Country Resort, San Diego, Calif.

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, 22q11.2 deletion syndrome and autism spectrum disorder. 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 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.

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

Zynerba Pharmaceuticals Announces Positive Top Line Results from Open-Label Phase 2 INSPIRE Trial of Zygel™ in 22q11.2 Deletion Syndrome

– The INSPIRE trial achieved statistically significant and clinically meaningful improvements from baseline in multiple efficacy assessments –

– Safety data reinforce excellent tolerability profile of Zygel –

– Company will focus resources on FXS and 22q development –

– Cash runway extended through the end of 2023 / early 2024 –

– Zynerba to host conference call and webcast tomorrow, June 22, 2022 at 9:00 a.m. ET –

Devon, PA, June 21, 2022 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today announced positive top line results from the exploratory, open label Phase 2 INSPIRE (Assessing the Impact of Zygel [Transdermal CBD Gel] on Pediatric Behavioral and Emotional Symptoms of 22q11.2 Deletion Syndrome) trial. Based on the positive Phase 2 data, the Company will request a meeting with the U.S. Food and Drug Administration (FDA) to discuss the data and the regulatory path forward.

The Phase 2 trial was designed for signal detection by assessing the safety, tolerability and efficacy of Zygel (also known as ZYN002) for the treatment of behavioral symptoms of chromosome 22q11.2 deletion syndrome (22q) in children and adolescents. Zygel was administered to patients with 22q as add-on therapy to their standard of care and utilized a variety of efficacy assessments. Key findings from the trial disclosed today include:

  • The total score and all five subscales of the Anxiety, Depression and Mood Scale (ADAMS) showed statistically significant improvements at 14 weeks of treatment compared to baseline;
  • All five subscales of the Aberrant Behavior Checklist – Community (ABC-C) showed statistically significant improvements at 14 weeks of treatment compared to baseline;
  • The Pediatric Anxiety Rating Scale (PARS – R) showed statistically significant improvements at 14 weeks of treatment compared to baseline;
  • The majority of patients showed clinically meaningful improvements at week 14 as demonstrated by the Clinical Global Impression – Improvement (CGI-I). Seventy-five percent of patients were rated by the clinicians as “improved”, “much improved” or “very much improved” with nearly two-thirds (62.5%) of the patients being “much improved” or “very much improved”;
  • Zygel was shown to be well tolerated, and the safety profile was consistent with previously released data from other Zygel clinical trials.

“I am encouraged with the results from the INSPIRE trial, particularly with the potential for real reductions in general anxiety, social withdrawal, and social avoidance in children and adolescents with chromosome 22q11.2 deletion syndrome,” said Tony J. Simon, Ph.D. Professor Emeritus at the University of California, Davis School of Medicine and the UC Davis MIND Institute. “I’m especially encouraged that ZYN002 is a unique, cannabidiol gel free of THC and manufactured to pharmaceutical specifications. Children and adolescents with 22q should avoid THC which may increase the likelihood of developing psychosis. I look forward to the further development of ZYN002 for this underserved population.”

“We believe the data from this Phase 2 trial are very encouraging and reinforce the potential of Zygel for the treatment of behavioral symptoms in children and adolescents with 22q, and we look forward to discussing the regulatory path forward with the FDA with these data in hand,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “In the near term, we will focus our resources on completing the RECONNECT trial for children and adolescents with Fragile X syndrome and progressing 22q.”

INSPIRE Trial Design
The 14-week INSPIRE trial was an open-label, Phase 2 clinical trial designed to evaluate the safety, tolerability and efficacy of Zygel in children and adolescents (ages four through 15) with genetically-confirmed 22q11.2 deletion syndrome. Enrolled patients received weight-based doses of 250 mg or 500 mg daily of Zygel. Patients were allowed to increase the daily dose after six weeks of treatment to 500 mg and 750 mg if the investigator felt such increase was appropriate. One patient’s dose was increased from 250 mg to 500 mg, and no patients increased to 750 mg in the treatment period. At the completion of the trial, thirteen (13) patients entered into an extension study for up to six months.

Patient Disposition and Baseline Demographics
Twenty (20) patients were enrolled in the trial, which was conducted at two clinical sites in Australia and one clinical site in the U.S. All 20 patients are included in the safety analysis. Seventeen (17) patients completed the 14-week trial and three patients discontinued. One patient was lost to follow-up, one patient withdrew due to adverse events not related to Zygel, and one patient withdrew consent. Efficacy analyses included 16 patients as one patient did not have valid assessments at week 14.

The mean age of patients enrolled in the trial was 9.9 years, and twelve (60%) of the patients were male. Patients weighed between 13.7 and 79.8 kilograms (mean=37.4; median=33.5).

Top-line Efficacy Results
As a signal-seeking Phase 2 trial, multiple efficacy assessments were administered, including the Anxiety, Depression and Mood Scale (ADAMS), the Aberrant Behavior Checklist – Community (ABC-C), the Pediatric Anxiety Ratings Scale (PARS – R) and Clinical Global Impression – Severity and Improvement.

Results of the ADAMS:

            Change from   Mean %       Median %
Subscale   Baseline   Week 14   Baseline   Improvement    p Value    Improvement
                         
Total Score   36.1   17.7   -18.4   45.3%   0.0005   43.0%
General Anxiety   10.4   5.1   -5.4   43.6%   0.0005   48.8%
Depressed Mood   7.6   3.4   -4.3   50.3%   0.0033   52.8%
Social Avoidance   8.7   4.3   -4.4   41.3%   0.0084   50.0%
Obsessive/Compulsive Behavior   3.0   1.1   -1.9   64.0%   0.0037   66.7%
Manic / Hyperactive Behavior   7.6   4.4   -3.1   38.2%   0.0032   27.4%
                         

Results of the ABC-C:

                         
            Change from   Mean %       Median %
Subscale   Baseline   Week 14   Baseline   Improvement    p Value    Improvement
                         
Social Withdrawal   14.4   7.9   -6.4   27.6%   0.0110   46.4%
Inappropriate Speech   4.2   2.4   -1.8   18.3%   0.0166   50.0%
Stereotypic Behavior   3.9   1.6   -2.3   52.1%   0.0155   58.3%
Irritability   18.4   10.0   -8.4   36.3%   0.0055   39.6%
Hyperactivity   18.1   10.4   -7.6   16.5%   0.0091   38.1%
                         

Results of the PARS – R:

                         
            Change from   Mean %        Median % 
    Baseline   Week 14   Baseline   Improvement    p Value     Improvement 
                         
Total Score   14.7   8.5   -6.2   40.6%   0.0005   40.0%

Results of the CGI-I:

The investigators rated 12 of 16 patients (75%) as improved, “much improved” or “very much improved” at week 14, with 62.5% being “much improved” or “very much improved”.

Safety Data
Zygel was shown to be well tolerated, and the safety profile was consistent with previously released data from other Zygel clinical trials. Three patients reported treatment related adverse events which were all mild application site adverse events. One patient discontinued treatment due to adverse events not related to Zygel.

Prioritizing Orphan Development Programs; Cash Runway Extended to Late 2023 / Early 2024
In the near term the Company has decided to prioritize its resources on Fragile X syndrome (FXS) and 22q, both of which have been granted orphan drug designation by the FDA and both of which have no approved products. While the data from the Company’s autism spectrum disorder (ASD) clinical development program to date are compelling, given the difficult financing market, the Company will defer the start of the Phase 3 development program in ASD previously planned for the second half of 2022. As a result, the Company now believes its $69.7 million of cash and cash equivalents as of March 31, 2022 are sufficient to fund planned operations and capital requirements through the end of 2023 or early 2024, after the expected availability of top line results from its confirmatory pivotal Phase 3 RECONNECT trial of Zygel in patients with FXS.

Conference call information
Zynerba management will host a live conference call and webcast tomorrow, June 22, 2022, at 9:00 a.m. Eastern Time to discuss results of the INSPIRE trial and updates to its clinical development plans. The call can be accessed by dialing (866) 573-0180 (U.S. and Canada) or (430) 775-1345 (international) and referencing conference ID 4453857. 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 22q11.2 Deletion Syndrome (22q)
As the second most common chromosomal disorder after Down syndrome, 22q is 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 challenges. Anxiety is among the most common neuropsychiatric symptoms of 22q and researchers have found that for children with 22q, anxiety is linked to poorer adaptive behaviors such as self-care and communication skills that affect daily life. Children with 22q also experience withdrawn behavior, ADHD, cognitive impairment, and autism spectrum disorder that affect communication and social interaction. Later in life, they are at an increased risk of developing mental illnesses such as schizophrenia. It is estimated that 22q occurs in between one in 3,000 and one in 6,000 live births, suggesting that there are approximately 83,000 people living with 22q in the U.S.

About Zygel
Zygel is the first and only pharmaceutically-manufactured cannabidiol formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled drug delivery into the bloodstream transdermally (i.e. through the skin). Recent studies suggest that cannabidiol may modulate the endocannabinoid system and improve certain behavioral symptoms associated with neuropsychiatric conditions. Zygel is an investigational drug product in development for the potential treatment of behavioral symptoms associated with Fragile X syndrome (FXS), 22q11.2 deletion syndrome (22q) and autism spectrum disorder (ASD). The Company has received orphan drug designation for cannabidiol, the active ingredient in Zygel, from the FDA and the European Commission for the treatment of FXS and by the FDA for the treatment of 22q. Additionally, Zygel has been designated a Fast Track development program for treatment of behavioral symptoms of FXS.

About Fragile X Syndrome (FXS)
FXS is a rare genetic developmental disability 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. It is the most common inherited intellectual disability in males and a significant cause of intellectual disability in females, and the leading genetic cause of autism spectrum disorder (ASD). 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. In the U.S., there are approximately 78,000 people suffering with FXS, and approximately 121,000 in the EU and UK. We believe that approximately 60% of all patients with FXS have complete methylation of their FMR1 gene.

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, 22q11.2 deletion syndrome and autism spectrum disorder. 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 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.

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

Zynerba Pharmaceuticals Presents Data on Zygel™ at the American Society of Clinical Psychopharmacology Annual Meeting

– Poster presentation highlights design enhancements incorporated into pivotal RECONNECT trial –

– Oral presentation demonstrates long-term safety and potential effectiveness of Zygel in children and adolescents with Fragile X syndrome –

Devon, PA, June 1, 2022 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, is presenting an oral podium presentation and a poster presentation at the American Society of Clinical Psychopharmacology Annual Meeting (ASCP 2022), being held May 31 – June 3, 2022, in Scottsdale, Ariz. Copies of the presentations are available on the Zynerba corporate website at http://zynerba.com/publications/.

“The RECONNECT trial provides us with an opportunity to confirm the positive results observed in a population of responders in our CONNECT-FX trial and further evaluate the effect of Zygel on behaviors associated with Fragile X syndrome (FXS),” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “Furthermore, the interim results from the open-label extension trial support the long-term safety and potential effectiveness of Zygel in children and adolescents with FXS, with the greatest improvements seen in those with complete methylation of their FMR1 gene, the population for the primary efficacy analysis in RECONNECT.”

The presentation titled, “Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017),” includes data demonstrating that in the ongoing long-term safety and efficacy trial of Zygel in children and adolescents with FXS, improvement was seen in Social Avoidance in the full population, with the greatest improvement in patients with complete methylation of their FMR1 gene. Patients with complete methylation, who match the primary efficacy population in the ongoing confirmatory trial, RECONNECT, achieved and maintained clinically meaningful change in Social Avoidance, supporting one of the key design enhancements for RECONNECT. Zygel was well-tolerated with long-term administration with up to 38 months of exposure.

The poster titled, “RECONNECT (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome Based Upon Learnings from CONNECT-FX (ZYN2-CL-016) Completed During SARS-COV-2 Pandemic,” describes how learnings from CONNECT-FX, the first randomized, double-blind, placebo-controlled trial of Zygel in the treatment of FXS, shaped the design of RECONNECT. In addition to the primary endpoint of the RECONNECT trial being measured in patients who have a completely methylated FMR1 gene, the treatment period of the trial has been extended by four weeks and an additional weight-based dose has been added for participants weighing greater than 50kg. RECONNECT is expected to provide key data to determine the effectiveness of Zygel in FXS while using a design intended to reduce the burden of participation in a clinical trial for families with children and adolescents with FXS.

About Zygel
Zygel is the first and only pharmaceutically-manufactured cannabidiol formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled drug delivery into the bloodstream transdermally (i.e. through the skin). Recent studies suggest that cannabidiol may modulate the endocannabinoid system and improve certain behavioral symptoms associated with neuropsychiatric conditions. Zygel is an investigational drug product in development for the potential treatment of behavioral symptoms associated with Fragile X syndrome (FXS), autism spectrum disorder (ASD), and 22q11.2 deletion syndrome (22q). The Company has received orphan drug designation for cannabidiol, the active ingredient in Zygel, from the FDA and the European Commission in the treatment of FXS and by the FDA for the treatment of 22q. Additionally, Zygel has been designated a Fast Track development program for treatment of behavioral symptoms of FXS.

About RECONNECT
RECONNECT is a randomized, double-blind, placebo-controlled, multiple-center efficacy and safety trial of Zygel administered as a transdermal gel to children and adolescents ages 3 through 17 with Fragile X syndrome. For more information regarding participation visit www.fragilexhelp.com.

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, 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; 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.

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

 

Zynerba Pharmaceuticals Announces Podium and Poster Presentations at the American Society of Clinical Psychopharmacology Annual Meeting

Devon, PA, May 24, 2022 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced an oral podium presentation and a poster presentation at the American Society of Clinical Psychopharmacology Annual Meeting (ASCP 2022), being held May 31 – June 3, 2022, in Scottsdale, Ariz. A copy of the presentations will be made available on the Zynerba corporate website following the presentations at http://zynerba.com/publications/.

Oral Podium Presentation Details
   
Title: Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017)
   
Date: Tuesday, May 31, 2022
   
Time:  4:20 p.m. MST (7:20 p.m. EDT)
   
Location: Fairmont Scottsdale Princess, Scottsdale, Ariz.
   
Poster Presentation Details
   
Title: RECONNECT (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome Based Upon Learnings from CONNECT-FX (ZYN2-CL-016) Completed During SARS-COV-2 Pandemic
   
Date: Wednesday, June 1, 2022
   
Time: 11:15 a.m. – 1:00 p.m. MST (2:15 p.m. – 4:00 p.m. EDT)
   
Location: Fairmont Scottsdale Princess, Scottsdale, Ariz.

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, 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; 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.

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

Zynerba Pharmaceuticals to Present at the H.C. Wainwright Global Investment Conference

Devon, PA, May 17, 2022 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that Armando Anido, Chairman and Chief Executive Officer of Zynerba Pharmaceuticals, will present virtually at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022.

A webcast of the presentation will be available on-demand May 24-26, 2022 under the Events & Webcasts tab of the Investors section of the Zynerba website at www.zynerba.com. Investors interested in arranging a virtual meeting with the Company’s management during the conference should contact the H.C. Wainwright conference coordinator. An archived replay will be available on the Company’s website following the event for 90 days.

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, 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; 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.

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

Zynerba Pharmaceuticals Reports First Quarter 2022 Financial Results and Operational Highlights

– Enrollment continues in RECONNECT, a confirmatory pivotal Phase 3 trial of Zygel™ in patients with Fragile X syndrome (FXS); topline results expected second-half 2023 –

– Topline results from Phase 2 trial of Zygel in patients with 22q11.2 deletion syndrome (22q) expected mid-year 2022 –

– $69.7 million in cash and cash equivalents at March 31, 2022; Cash runway into second-half 2023 –

Devon, PA, May 16, 2022 — 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 first quarter ended March 31, 2022, and provided an overview of recent operational highlights and a pipeline update.

“We are excited by the opportunities ahead for Zygel in FXS and other rare and near-rare neuropsychiatric indications, and have made meaningful progress since the beginning of this year,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “Specifically, during the first quarter of 2022, we continued to enroll patients in our Phase 3 pivotal trial in patients with FXS, completed enrollment in our Phase 2 trial in patients with 22q11.2 deletion syndrome and advanced toward submission of an Investigational New Drug application for a Phase 3 trial in patients with ASD that we expect to initiate in the second half of 2022.”

Operational Highlights and Pipeline Update

Zygel in Fragile X Syndrome (FXS)

  • The Company continues to expect topline results from RECONNECT, a confirmatory pivotal Phase 3 trial of Zygel in patients with FXS, in the second half of 2023. The Company believes that the results from RECONNECT, if positive, will be sufficient to support the submission of a New Drug Application (NDA) for Zygel in patients with FXS.
  • During the first quarter of 2022, Zynerba received orphan drug designation for cannabidiol, the active ingredient in Zygel, for the treatment of FXS from the European Commission. As previously announced, the Company believes, based on the scientific advice of the European Medicines Agency, that the successful completion of the current development program for Zygel in FXS will satisfy the requirements of a marketing authorization application in the European Union.
  • Presented data at the 2022 Society of Biological Psychiatry (SOBP) Annual Meeting in April and the 2022 International Society for Autism Research (INSAR) Annual Meeting in May demonstrating that in the long-term safety and efficacy study of Zygel in children and adolescents with FXS, improvement was seen in Social Avoidance in the full population, with the greatest improvement in patients with complete methylation of the FMR1 gene. Patients with complete methylation, who match the primary efficacy population in the ongoing confirmatory trial, RECONNECT, achieved and maintained meaningful change in Social Avoidance, supporting design enhancements for RECONNECT. (Poster and Presentation)

Zygel in 22q11.2 Deletion Syndrome (22q)

  • In the first quarter of 2022, the Company completed enrollment for the 14-week open-label Phase 2 INSPIRE trial in children and adolescents with genetically confirmed 22q. The Company continues to expect topline data from INSPIRE mid-year 2022. A total of 20 patients have been enrolled in the INSPIRE trial.
  • The Company plans to move forward in 22q as an orphan indication pending results from the INSPIRE trial, and subsequent discussion with the U.S. Food and Drug Administration (FDA) on the regulatory path forward. The Company has previously received orphan drug designation from the FDA for cannabidiol, the active ingredient in Zygel, for the treatment of 22q.

Zygel in Autism Spectrum Disorder (ASD)

  • The Company is finalizing the Phase 3 study protocol and will submit an Investigational New Drug application to the FDA prior to commencing the pivotal program. The Company expects to initiate the first of two Phase 3 trials in patients with ASD in the second half of 2022.
  • As previously announced, earlier discussions with the FDA included agreement on utilizing the irritability subscale of the Aberrant Behavior Checklist – Community (ABC-C) as the primary endpoint to support an indication for the treatment of irritability in ASD. This is the same primary endpoint utilized in the pivotal trials for the two existing FDA approved treatments for ASD.

First Quarter 2022 Financial Results
Research and development expenses were $5.1 million for the first quarter of 2022, including stock-based compensation of $0.5 million. General and administrative expenses were $3.8 million in the first quarter of 2022, including stock-based compensation expense of $0.6 million. Net loss for the first quarter of 2022 was $8.5 million, with basic and diluted loss per share of $(0.21).

Financial Outlook
As of March 31, 2022, cash and cash equivalents were $69.7 million, compared to $67.8 million as of December 31, 2021. On May 11, 2021, the Company entered into a Controlled Equity OfferingSM Sales Agreement, or the 2021 Sales Agreement”, with Cantor Fitzgerald & Co., Canaccord Genuity, LLC, H.C. Wainwright & Co. LLC and Ladenburg Thalmann & Co. Inc., as sales agents, pursuant to which the Company may sell, from time to time, up to $75.0 million of its common stock. In the first quarter of 2022, the Company sold and issued 857,060 shares of its common stock under the 2021 Sales Agreement in the open market resulting in gross proceeds of $1.8 million and net proceeds of $1.6 million, after deducting commissions and offering expenses. From April 1, 2022 through May 13, 2022, the Company sold and issued 297,362 shares of its common stock under the 2021 Sales Agreement in the open market resulting in gross proceeds and net proceeds of $0.6 million, after deducting commissions and offering expenses.

During the three months ended March 31, 2022, the Company received a payment of $8.0 million from the Australian Tax Office for research and development incentives for the years ended December 31, 2018, 2019 and 2020.

Management believes that the Company’s cash and cash equivalents are sufficient to fund operations and capital requirements into the second half of 2023.

About Zygel
Zygel is the first and only pharmaceutically-manufactured cannabidiol formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled drug delivery into the bloodstream transdermally (i.e. through the skin). Recent studies suggest that cannabidiol may modulate the endocannabinoid system and improve certain behavioral symptoms associated with neuropsychiatric conditions. Zygel is an investigational drug product in development for the potential treatment of behavioral symptoms associated with Fragile X syndrome (FXS), autism spectrum disorder (ASD), and 22q11.2 deletion syndrome (22q). The Company has received orphan drug designation for cannabidiol, the active ingredient in Zygel, from the FDA and the European Commission in the treatment of FXS and by the FDA for the treatment of 22q. Additionally, Zygel has been designated a Fast Track development program for treatment of behavioral symptoms of FXS.

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, 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 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; 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.



ZYNERBA PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

  (unaudited)  
  Three months ended March 31,  
    2022       2021    
Operating expenses:        
Research and development $ 5,146,605     $ 4,609,010    
General and administrative   3,757,310       3,275,797    
Total operating expenses   8,903,915       7,884,807    
Loss from operations   (8,903,915 )     (7,884,807 )  
Other income (expense):        
Interest income   96,044       5,633    
Foreign exchange gain (loss)   317,252       (82,454 )  
Total other income (expense)   413,296       (76,821 )  
Net loss $ (8,490,619 )   $ (7,961,628 )  
         
Net loss per share – basic and diluted $ (0.21 )   $ (0.20 )  
         
Basic and diluted weighted average shares outstanding   40,304,484       40,065,715    
         
Non-cash stock-based compensation included above:        
Research and development $ 529,496     $ 619,391    
General and administrative   630,986       645,446    
Total $ 1,160,482     $ 1,264,837    
         



ZYNERBA PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

  (unaudited)      
  March 31, 2022      December 31, 2021  
Assets        
Current assets:        
Cash and cash equivalents $ 69,697,865     $ 67,808,000    
Incentive and tax receivables   1,602,831       9,580,468    
Prepaid expenses and other current assets   1,930,380       2,831,392    
Total current assets   73,231,076       80,219,860    
Property and equipment, net   376,745       385,833    
Incentive and tax receivables   264,206          
Right-of-use assets   509,002       565,814    
Total assets $ 74,381,029     $ 81,171,507    
Liabilities and Stockholders’ Equity        
Current liabilities:        
Accounts payable $ 1,603,834     $ 1,798,813    
Accrued expenses   7,103,959       7,896,598    
Lease liabilities   210,512       209,068    
Total current liabilities   8,918,305       9,904,479    
Lease liabilities, long-term   295,754       353,694    
Total liabilities   9,214,059       10,258,173    
         
Stockholders’ equity:        
Common stock   43,324       41,218    
Additional paid-in capital   313,095,744       310,353,595    
Accumulated deficit   (247,972,098 )     (239,481,479 )  
Total stockholders’ equity   65,166,970       70,913,334    
Total liabilities and stockholders’ equity $ 74,381,029     $ 81,171,507    
         

 

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

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

 


Zynerba Pharmaceuticals Presents Long-Term Safety and Efficacy Data of Zygel™ in Children and Adolescents with Fragile X Syndrome (FXS) at the International Society for Autism Research Annual Meeting

– Data support the long-term safety and effectiveness of Zygel –

– Greatest improvements seen in those with complete methylation of their FMR1 gene –

Devon, PA, May 11, 2022 — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, is presenting an oral podium presentation at the International Society for Autism Research Annual Meeting (INSAR 2022), being held both in-person and virtually May 11-14, 2022, from Austin, TX. A copy of the presentation will be made available on the Zynerba corporate website following the presentation on May 12, 2022, at 4:30 p.m. ET at http://zynerba.com/publications/.

The presentation titled, “Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017),” includes data from 240 patients and demonstrates the long-term safety and efficacy of Zygel in children and adolescents with FXS.

The study includes patients who entered the trial from two completed trials with Zygel: CONNECT-FX, a randomized, double-blind, placebo-controlled Phase 3 trial, and FAB-C, the initial open-label Phase 2 trial in FXS. The efficacy data were evaluated through 15 months of treatment and demonstrated improvements in both ABC-CFXS Social Avoidance and Irritability subscales. Patients with complete methylation of their FMR1 gene who completed CONNECT-FX and matched the primary efficacy population in the ongoing confirmatory RECONNECT trial achieved and maintained clinically meaningful change in ABC-CFXS Social Avoidance, and demonstrated similar improvements in ABC-CFXS Irritability subscale scores. These finding support the design enhancements that were made for RECONNECT.

Zygel was well tolerated in patients, with a median duration of exposure of 16 months (range 21 days to 38 months). Adverse events potentially related to Zygel were reported in 12.9% of patients; the most common reported in 6.7% of patients was application site pain which resolved quickly and was mild in the majority of cases.

“The interim results from this open-label extension trial support the long-term safety and effectiveness of Zygel in children and adolescents with Fragile X syndrome, with the greatest improvements seen in those with complete methylation of their FMR1 gene,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We are excited by the potential that Zygel may offer for patients with FXS.”

About Zygel
Zygel is the first and only pharmaceutically-manufactured cannabidiol formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled drug delivery into the bloodstream transdermally (i.e. through the skin). Recent studies suggest that cannabidiol may modulate the endocannabinoid system and improve certain behavioral symptoms associated with neuropsychiatric conditions. Zygel is an investigational drug product in development for the potential treatment of behavioral symptoms associated with Fragile X syndrome (FXS), autism spectrum disorder (ASD), and 22q11.2 deletion syndrome (22q). The Company has received orphan drug designation for cannabidiol, the active ingredient in Zygel, from the FDA and the European Commission in the treatment of FXS and by the FDA for the treatment of 22q. Additionally, Zygel has been designated a Fast Track development program for treatment of behavioral symptoms of FXS.

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, 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; 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.

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