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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15 (d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): November 9, 2020

 

 

 

ZYNERBA PHARMACEUTICALS, INC.

(Exact Name of Issuer as Specified in Charter)

 

 

 

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

 

80 W. Lancaster Avenue, Suite 300

Devon, PA 19333

(Address of Principal Executive Offices)

 

(484) 581-7505

(Registrant’s Telephone Number, Including Area Code)

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

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

 

 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Emerging growth company x

 

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

 

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition

 

On November 9, 2020, Zynerba Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results and operational highlights for the third quarter ended September 30, 2020. A copy of this press release is furnished as Exhibit 99.1 hereto.

 

The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 8.01 Other Events

 

Attached as Exhibit 99.2 is a presentation, including certain financial information, that the Company will post on its website on November 9, 2020 and may use from time to time in presentations or discussions with investors, analysts or other parties.

 

Item 9.01      Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit
No.
  Document
     
99.1   Press Release, dated November 9, 2020*
99.2   Zynerba Pharmaceuticals, Inc. Presentation**
104   The cover page from this current report on Form 8-K, formatted in Inline XBRL

 

* Furnished herewith

** Filed herewith

 

 

 

 

 

SIGNATURE

 

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

 

Date: November 9, 2020

 

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

 

 

 

 

Exhibit 99.1

 

 

 

Zynerba Pharmaceuticals Reports Third Quarter 2020 Financial Results

and Operational Highlights

 

DEVON, Pa., November 9, 2020 -- Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today reported financial results for the third quarter ended September 30, 2020, and provided an overview of recent operational highlights.

 

“We made good clinical, operational and regulatory progress during the third quarter of 2020 including presenting new data from the pivotal CONNECT-FX and Phase 2 BRIGHT trials, and completing our discussions with the FDA to clarify our clinical path forward to late stage clinical trials in patients with certain developmental and epileptic encephalopathies,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “The fourth quarter of this year is another important period for Zynerba. In particular, we look forward to announcing the results of our fourth quarter meeting with the FDA to discuss our pivotal CONNECT-FX results in patients with a fully methylated FMR1 gene and to understand the regulatory path forward.”

 

Third quarter 2020 and Recent Highlights

 

Zygel in Fragile X Syndrome (FXS)

 

Zynerba Expects to Announce the Outcome of its Fourth Quarter Meeting with the U.S. Food and Drug Administration (FDA) to Discuss the CONNECT-FX Trial and the Regulatory Path Forward for Zygel™ in Pediatric and Adolescent Patients with a Fully Methylated FMR1 Gene (FMet) in the Fourth Quarter of 2020 (Press release)

 

Presented New CONNECT-FX Data Supporting FMR1 Methylation Status as a Correlate to Fragile X Syndrome Severity at the Virtual Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting

 

Zynerba utilized psychometric analyses to determine what constitutes a clinically meaningful change from baseline as measured by subscales of the ABC-CFXS. The results of these analyses defined a clinically meaningful treatment response over 12 weeks of treatment as an improvement of three points or greater for the Social Avoidance subscale, nine points or greater for the Irritability subscale, and five points or greater for the Socially Unresponsive / Lethargic subscale. Through this analysis, the Company determined that 58.2% of FMet patients receiving Zygel achieved a clinically meaningful change in their socially avoidant behavior compared to 40.6% of patients receiving placebo (p=0.031; statistically significant), and 40.3% of patients receiving Zygel achieved a clinically meaningful change in Irritability compared to 23.8% of patients receiving placebo (p=0.036; statistically significant). (Press release)

 

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Presented CONNECT-FX Data Showing Statistically Significant Caregiver-Reported Improvements in Most Impactful FXS Behaviors at the 17th NFXF International Conference Research Roundup; Results Support Statistically Significant Results of Pre-planned Ad Hoc Analysis in FMet Patients

 

Consistent with guidance from the FDA on capturing the voice of the patient in drug development, the Company collected qualitative data on the clinical relevance of various FXS behaviors to caregivers during CONNECT-FX. The results of the Qualitative Caregiver Reported Behavioral Survey indicate that caregivers found anxiety, socially avoidant behaviors, and disruptive behaviors to be the most challenging. The results of the Caregiver Global Impression – Change survey show a broad shift toward global improvement from baseline to week 12 in FMet patients, with three of the four behavioral domains (social avoidance and isolation, irritable and disruptive behaviors, and social interactions) showing statistically significant improvements in favor of patients on Zygel compared to placebo and the fourth domain (overall behavior) trending toward significance. (Press release)

 

Received New U.S. Patent for Treatment of Fragile X Syndrome with Cannabidiol

 

The U.S. Patent and Trademark Office issued US Patent No. 10,758,497, titled “Treatment of Fragile X Syndrome with Cannabidiol” which includes claims directed to a method of treating FXS comprising administering 250mg or 500mg of synthetic or purified cannabidiol in a pharmaceutically acceptable carrier to a person in need thereof. This new patent, which expires in 2038, is part of an expanding intellectual property portfolio covering Zygel. (Press release)

 

Zygel in Autism Spectrum Disorder (ASD)

 

Zynerba Intends to Discuss the Results of the Phase 2 BRIGHT Trial in Children and Adolescents with Moderate to Severe ASD and the Path Forward with the FDA in the First Half of 2021

 

Presented New Data Describing Statistically Significant Results from the Phase 2 BRIGHT Trial in Patients with Autism Spectrum Disorder (ASD) at the Virtual Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting

 

Patients receiving Zygel in this study achieved statistically significant caregiver-reported improvements compared to baseline across all subscales of the Autism Impact Measure, which was designed to measure change in frequency and impact of core ASD symptoms: Atypical behavior (p<0.001), Communication (p<0.001), Peer Interaction (p<0.001), Repetitive Behavior (p<0.001), and Social Reciprocity (p=0.0053). In addition, statistically significant improvements compared to baseline were observed at week 14 of treatment with Zygel in the Autism Parenting Stress Index (p<0.0001). Zynerba also measured notable improvements in behaviors utilizing the Qualitative Caregiver Behavioral Problems Survey after 14 weeks of study drug. Clinically meaningful improvements were observed by a majority of surveyed caregivers in behavioral, social and emotional behavioral problems. (Press release)

 

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

 

Received Orphan Drug Designation for Cannabidiol for the Treatment of 22q11.2 Deletion Syndrome

 

The FDA granted orphan drug designation for cannabidiol for use in treating 22q, a rare midline condition featuring physical abnormalities and debilitating neuropsychiatric and behavioral symptoms including anxiety, withdrawn behavior, and social interaction problems. Companies receiving orphan drug designation may be entitled to various incentives, including tax credits for qualified clinical studies, waiver of new drug application (NDA) / biologics license application (BLA) user fees, and eligibility for a seven-year exclusive marketing period for that drug and use upon marketing approval. (Press release)

 

Zygel in Developmental and Epileptic Encephalopathies (DEE)

 

Concluded Successful Discussions with FDA Regarding the DEE Program and Path Forward; Evaluation of Initial Targets for Late Stage Clinical Evaluation Progressing

 

Zynerba concluded its iterative discussions with the FDA utilizing their ‘Written Response Only’ (WRO) meeting format regarding the clinical pathway for Zygel in DEE during which the FDA expressed support for a development program which would evaluate the treatment of focal-impaired awareness and convulsive seizures. Due to the heterogeneity of patients who fall under the DEE umbrella, Zynerba will pursue individual syndromes rather than considering DEE as a single disorder or condition. The Company is in the process of finalizing its evaluation of which epileptic syndromes it may pursue with Zygel, and expects to disclose its first clinical target around year end 2020. (Press release)

 

Third quarter 2020 Financial Results

 

As of September 30, 2020, cash and cash equivalents were $64.3 million, compared to $70.1 million as of December 31, 2019. Research and development expenses for the third quarter of 2020 were $5.8 million, including stock-based compensation of $0.5 million. General and administrative expenses for the third quarter of 2020 were $3.4 million, including stock-based compensation expense of $0.7 million. The net loss for the third quarter of 2020 was $9.0 million with basic and diluted net loss per share of $(0.31).

 

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Financial Outlook

 

Management believes that the current cash and cash equivalents is sufficient to fund operations and capital requirements until late in the fourth quarter of 2021.

 

About Zynerba Pharmaceuticals, Inc.

 

Zynerba Pharmaceuticals is the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X syndrome, autism spectrum disorder, 22q11.2 deletion syndrome, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies. Learn more at www.zynerba.com and follow us on Twitter at @ZynerbaPharma.  

  

Cautionary Note on Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, incentive and other tax credit eligibility, collectability and timing, and availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its clinical development programs; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; clinical results for the Company’s product candidates may not be replicated or continue to occur in additional trials and may not otherwise support further development in a specified indication or at all; actions or advice of the U.S. Food and Drug Administration and foreign regulatory agencies may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company’s ability to obtain and maintain regulatory approval for its product candidates, and the labeling under any such approval; the Company’s reliance on third parties to assist in conducting pre-clinical and clinical trials for its product candidates; delays, interruptions or failures in the manufacture and supply of the Company’s product candidates the Company’s ability to commercialize its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates; the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates; the timing and outcome of current and future legal proceedings; and the extent to which health epidemics and other outbreaks of communicable diseases, including COVID-19, could disrupt our operations or adversely affect our business and financial conditions. This list is not exhaustive and these and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

  

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ZYNERBA PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

  

   Three months ended September 30,   Nine months ended September 30, 
   2020   2019   2020   2019 
Operating expenses:                    
Research and development  $5,805,948   $(1,604,399)  $30,038,582   $12,926,096 
General and administrative   3,425,831    3,530,617    11,834,434    9,977,550 
Total operating expenses   9,231,779    1,926,218    41,873,016    22,903,646 
Loss from operations   (9,231,779)   (1,926,218)   (41,873,016)   (22,903,646)
Other income (expense):                    
Interest income   10,781    436,846    239,066    1,226,998 
Foreign exchange gain (loss)   172,467    (457,018)   (85,171)   (551,944)
Total other income (expense)   183,248    (20,172)   153,895    675,054 
Net loss  $(9,048,531)  $(1,946,390)  $(41,719,121)  $(22,228,592)
                     
Net loss per share - basic and diluted  $(0.31)  $(0.08)  $(1.59)  $(1.03)
                     
Basic and diluted weighted average shares outstanding   29,243,375    23,186,410    26,258,626    21,598,764 
                     
Non-cash stock-based compensation included above:                    
Research and development  $544,909   $573,446   $1,590,285   $1,915,578 
General and administrative   717,716    802,779    2,343,125    2,438,644 
Total  $1,262,625   $1,376,225   $3,933,410   $4,354,222 

  

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ZYNERBA PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

 

   (unaudited)     
   September 30, 2020   December 31, 2019 
Assets          
Current assets:          
Cash and cash equivalents  $64,311,205   $70,063,242 
Incentive and tax receivables   6,533,079    14,613,969 
Prepaid expenses and other current assets   3,913,112    2,378,812 
Total current assets   74,757,396    87,056,023 
Property and equipment, net   596,512    362,724 
Incentive and tax receivables   1,684,616     
Right-of-use assets   166,889    345,849 
Total assets  $77,205,413   $87,764,596 
Liabilities and Stockholders' Equity          
Current liabilities:          
Accounts payable  $3,404,129   $4,740,981 
Accrued expenses   6,987,653    7,073,506 
Lease liabilities   174,073    243,677 
Total current liabilities   10,565,855    12,058,164 
Lease liabilities, long-term       109,689 
Total liabilities   10,565,855    12,167,853 
           
Stockholders' equity:          
Common stock   29,449    23,211 
Additional paid-in capital   259,164,854    226,409,156 
Accumulated deficit   (192,554,745)   (150,835,624)
Total stockholders' equity   66,639,558    75,596,743 
Total liabilities and stockholders' equity  $77,205,413   $87,764,596 

  

Zynerba Contacts

 

Jim Fickenscher, CFO and VP Corporate Development

Zynerba Pharmaceuticals

484.581.7483

fickenscherj@zynerba.com

 

Will Roberts, VP Investor Relations and Corporate Communications

Zynerba Pharmaceuticals

484.581.7489

robertsw@zynerba.com

 

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Exhibit 99.2

 

Corporate Overview November 2020

 

 

Forward - Looking Statements 2 © 2020 Zynerba Pharmaceuticals, Inc. All rights reserved. Zynerba and Zygel are trademarks of Zynerba Pharmaceuticals, Inc. All other trademarks and registered trademarks are property of their respective owners. trademarks are property of their respective owners. THE STATEMENTS IN THIS PRESENTATION MAY INCLUDE FORWARD - LOOKING STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. THESE STATEMENTS, AMONG OTHER THINGS RELATE TO THE FUTURE OPERATIONS, OPPORTUNITIES OR FINANCIAL PERFORMANCE OF ZYNERBA PHARMACEUTICALS, INC. 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, 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 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; AND THE COMPANY’S EXPECTATIONS REGARDING ITS ABILITY TO OBTAIN AND ADEQUATELY MAINTAIN SUFFICIENT INTELLECTUAL PROPERTY PROTECTION FOR ITS PRODUCT CANDIDATES. THESE AND OTHER RISKS ARE DESCRIBED IN OUR FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION, AVAILABLE AT WWW.SEC.GOV. ANY FORWARD - LOOKING STATEMENTS THAT THE COMPANY MAKES IN THIS PRESENTATION SPEAK ONLY AS OF THE DATE OF THIS PRESENTATION. 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 PRESENTATION .

 

 

Zynerba Pharmaceuticals (NASDAQ: ZYNE) 3 A Rare/Near - Rare Neuropsychiatric Company • Deep pipeline focused on high unmet medical needs; translating into multi - billion dollar market opportunity with Zygel ™ (Cannabidiol Gel) • Currently pursuing four neuropsychiatric indications: • Fragile X syndrome (FXS) – pivotal trial complete • Developmental and epileptic encephalopathies (DEE) – Phase 2 complete • Autism spectrum disorder (ASD) – Phase 2 complete • 22q11.2 deletion syndrome (22q) – Phase 2 ongoing • Experienced team • Proven development and commercialization track record in transdermal delivery, orphan diseases, neurology, and psychiatry • Well capitalized: Cash runway expected to last until late in 4Q2021 • Multiple expected near term milestones

 

 

Deep Clinical Pipeline 4 Zygel Cannabidiol Gel Expected Milestones Meet with FDA to discuss pivotal results in patients with a fully methylated FMR1 gene in 4Q2020; outcome also expected in 4Q2020 Discuss Phase 2 results and clinical path forward with FDA in 1H2021 Completion of enrollment once COVID - 19 restrictions in Australia are eased Communicate specific DEE syndrome(s) for further clinical development around year - end 2020 *Orphan Drug and Fast Track designation **Orphan Drug designation

 

 

Neuropsych Indications Differentiated Formulation delivers Cannabidiol through the epidermis and into the circulatory system Zygel (ZYN002) Cannabidiol Gel 5 Unique Mechanism of Action First & only patent - protected (2038), permeation - enhanced, pharmaceutically - produced Cannabidiol gel Transdermal Cannabidiol modulates multiple receptors and mediates numerous pathways, including the endocannabinoid pathway Potential utility in rare / near - rare neuropsychiatric conditions FDA Fast Track and Orphan Drug designations in FXS Orphan Drug designation in 22q

 

 

Fragile X Syndrome (FXS) 6

 

 

Fragile X Syndrome (FXS) Overview 7 • Rare genetic developmental disability • Leading known cause of both inherited intellectual disability and autism spectrum disorder • Symptoms linked to deficiencies in the endocannabinoid system (ECS) • System of neurotransmitters regulates emotional responses, behavioral reactivity to context, social interaction • Mutation in FMR1 gene on the X chromosome causes dysregulation of the EC system and results in core cognitive, social, and behavioral symptoms of FXS • ~70K U.S. patients, of whom ~40K have a fully methylated FMR1 gene ( FMet ) • No approved drugs indicated for FXS

 

 

8 • FMR1 gene codes for production of FMRP* which is vital to synapse development • Mutation manifests as multiple repeats of a DNA segment (CGG) in FMR1 • No Fragile X: Segment repeats 5 to 40 times; normal production of FMRP • Premutation Fragile X: Segment repeats 50 to 200 times; reduced FMRP production • Full mutation FXS: Segment repeats >200 times; usually causes severely impacted or non - functional FMR1 and leads to core FXS behaviors • Methylation of FMR1 also plays a role in determining functionality of the gene • At ≥90% methylation (“full methylation” or FMet ), FMR1 is silenced • No FMRP is produced: Systems and processes affected by FMRP become dysregulated • Patients with full mutation FXS and full methylation of FMR1 are generally the most severely impacted by the disorder: lower IQ, more impacted behaviors • ~60% of patients with full mutation FXS are believed to fall into this category Fragile X Syndrome (FXS) Overview Full Methylation ( FMet ) of FMR1 Gene May be a Biomarker for Disease Impact *FMR Protein; RNA - binding protein that helps regulate synaptic development and plasticity

 

 

Proposed MOA of Cannabidiol in patients with FXS and fully methylated FMR1 gene 9 • FMRP affects multiple intracellular processes • Endocannabinoid system • Glutamate and GABA feedback loops • FMet patients • Males produce no FMRP • Females have significant reduction in FMRP • Absence or loss of FMRP is correlated with behavioral and cognitive deficits • Cannabidiol in FMet patients • Attenuates the disruption of the ECS by increasing the availability of the endocannabinoids (2 - AG and anandamide) • Modulates the glutamate and GABA feedback loops

 

 

CONNECT - FX: A Pivotal Trial In FXS 10 C linical study O f Ca NN abidiol in Childr E n and Adoles C en T s with F ragile X (CONNECT - FX) Zygel (n=110) 250 mg daily 500 mg daily (weight - based dose) Placebo (n=102) Mirrors Zygel administration Treatment 212 patients randomized Three through 17 years of age Screening Open label extension (OLE) 12 weeks* 12 months Patients randomized (1:1) to receive either Zygel or placebo *2 weeks placebo period, followed by 12 weeks treatment.

 

 

11 CONNECT - FX Baseline Characteristics Placebo Zygel Total n 102 110 212 Age (years) 9.8 9.6 9.7 Sex – Males , n (%) 78 (76%) 81 (74%) 159 (75%) Weight (kg) Median 34.3 36.8 35.7 Range (Min, Max) 15.6, 104.7 14.6, 87.0 14.6, 104.7 >35kg, % 48% 56% 52% Baseline psychoactive medications, % 66% 57% 62%

 

 

12 CONNECT - FX: Qualitative Caregiver Reported Behavioral Survey Top 10 Classifications of Behavioral Challenges Utilizing the Qualitative Caregiver Reported Behavioral Survey, caregivers were asked to describe their most important behavioral challenges at baseline 66% 42% 33% 30% 29% 28% 26% 23% 22% 22% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Anxiety Aggression Temper Tantrums Easily distracted Irritable/Whiny Excessive Activity Repetitive Speech Communication issues Elopement Seeks Isloation from others

 

 

CONNECT - FX: A Pivotal Trial In FXS 13 • Primary endpoint: • Change from baseline to end of treatment in ABC - C FXS Social Avoidance subscale • Key secondary endpoints: • Change from baseline to end of the treatment in • ABC - C FXS Irritability subscale score • ABC - C FXS Socially Unresponsive/Lethargic subscale score • Improvement in Clinical Global Impression (CGI - I) at end of treatment, anchored to FXS behaviors • Aligned with FDA’s ‘Voice of the Patient’ Guidance • Captured qualitative data on clinical relevance of FXS behaviors Zygel did not statistically significantly separate from placebo on the primary or key secondary endpoints in the full analysis set

 

 

14 • Methylation of genes is considered to be important in numerous pathological disorders including FXS • Methylation has been associated with the mechanism of mGluR5 in FXS • Currently, treatment options are limited for many of these disorders • The degree of methylation can influence the severity of FXS symptoms • Pre - planned analysis of the most severely impacted patients defined by patients having ≥90% methylation (“full methylation” or “ FMet ”) of the impacted FMR1 gene • 80% of the patients enrolled in CONNECT - FX were FMet • Analysis to explore differences in two groups: • FMet group (n=167) • Non - FMet group (n=42) CONNECT - FX Background CONNECT - FX: Rationale for Pre - Planned Ad Hoc Analysis Building on the Scientific Evidence

 

 

CONNECT - FX 15 Patients Full Data Set FMet Group Non - FMet Group Randomization (ITT) 212 169 42 Full Analysis set 210 167 42 • One patient did not receive study medication after randomization and one patient did not have post - baseline efficacy assessments resulting in 210 patients in Full Analysis set • One patient with FMR1 gene deletion was not included in either the FMet or Non - FMet groups Full Data Set, FMet and Non - FMet Patient Disposition: FMet Group Comprised 80% of Full Data Set Patients

 

 

CONNECT - FX: Demographics and Baseline Characteristics 16 Similar in the Full Data Set and FMet Group Full Data Set Group FMet Group Placebo Zygel Total Placebo Zygel Total n 102 110 212 77 92 169 Age (years) 9.8 9.6 9.7 9.6 9.2 9.4 Sex – Males (%) 78 (76%) 81 (74%) 159 (75%) 54 (70%) 65 (71%) 119 (70%) Weight (kg) Median 34.3 36.8 35.7 33.9 35.7 35.0 Range (Min, Max) 15.6, 104.7 14.6, 87.0 14.6, 104.7 15.6, 104.7 14.6, 87.0 14.6, 104.7 >35kg, % 48% 56% 52% 46% 53% 50% Baseline psychoactive medications, % 66% 57% 62% 65% 54% 59%

 

 

Pre - Planned Ad Hoc Results: FMet Group 17 Zygel Achieved Statistical Significance on Social Avoidance: Changes From Baseline to Week 12 (ABC - C FXS ) Placebo N=76 Zygel N=91 Endpoints Baseline Mean (SE) Week 12 Mean (SE) Week 12 Median Percent Change Baseline Mean (SE) Week 12 Mean (SE) Week 12 Median Percent Change Treatment Difference / Odds Ratio † Treatment p - value Social Avoidance 7.18 (0.32) 5.41 (0.42) - 21.1 7.12 (0.29) 4.32 (0.33) - 40.0 - 1.00 0.020* Irritability 28.0 (1.56) 24.11 (1.56) - 11.6 29.36 (1.37) 22.69 (1.42) - 24.3 - 2.30 0.091 Socially Unresponsive /Lethargic 13.17 (0.85) 10.29 (0.80) - 20.5 13.30 (0.68) 9.03 (0.67) - 30.8 - 1.17 0.135 CGI - I - 35.7% - 51.1% 1.88 † 0.056 Primary Endpoint Secondary Endpoints *Statistically significant

 

 

CONNECT - FX: ABC - C FXS Social Avoidance Changes From Baseline to Week 12 in FMet Group 18 In placebo group, the most common change (mode) in Social Avoidance was zero 0 2 4 6 8 10 12 14 16 18 20 22 24 -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 Placebo (n=75) Number of patients Change from baseline to week 12 Improvement Placebo mode = 0 Each dot represents a patient

 

 

19 Zygel group demonstrated greater improvement versus placebo 0 2 4 6 8 10 12 14 16 18 20 22 24 -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 Zygel (n=88) Placebo mode = 0 Zygel mode = −4 Nearly twice (1.9x) as many Zygel children experienced changes of 4 or more points relative to placebo (n=36 vs n=19) 3.5 - times as many Zygel children made improvements of 7 or more points in Social Avoidance relative to placebo (n=14 vs n=4) Values greater than zero Placebo: 9/75 = 12.0% Zygel: 12/88 = 13.6% Change from baseline to week 12 Number of patients Placebo (n=75) Data represent observed cases: 4 patients did not have Week - 12 ABC - C FXS assessment CONNECT - FX: ABC - C FXS Social Avoidance Changes From Baseline to Week 12 in FMet Group Each dot represents a patient

 

 

CONNECT - FX: Caregiver Global Impression - Change: FMet Group 0 10 20 30 40 50 60 70 Placebo Zygel Change from Baseline to Week 12: Broad Shifts Towards Global Improvement Placebo Zygel Placebo Zygel Placebo Zygel Overall Behavior Social Interactions Irritable and Disruptive Behaviors Social Avoidance and Isolation Percentage of patients Placebo n=76 Zygel n=91 p=0.002* p=0.028* p=0.052 p=0.038* Much better Moderately better A little better *Statistically significant P - values indicate “betterment” on Zygel vs “betterment” on placebo 20

 

 

Psychometric Analyses Determined Clinically Meaningful Changes for ABC - C FXS 21 • Clinically meaningful treatment responses over 12 weeks of treatment determined to be an improvement of: • Three (3) points or greater for the Social Avoidance subscale • Nine (9) points or greater for the Irritability subscale • Five (5) points or greater for the Socially Unresponsive / Lethargic subscale Data reported at the 2020 Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting

 

 

22 FMet Patients With Clinically Meaningful Change in ABC - C FXS Subscales 40.6 58.2 0 10 20 30 40 50 60 70 Placebo Zygel Data reported at the 2020 Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting 23.8 40.3 Placebo Zygel Socially Unresponsive/ Lethargic (Change ≥ 5) Irritability (Change ≥ 9) Social Avoidance (Change ≥ 3) Percentage of patients Placebo n=76 ZYN002 n=91 P=0.036* OR 2.17 P=0.031* OR 2.04 31.7 42.1 Placebo Zygel P=0.184 OR 1.57 OR= odds ratio *Statistically significant. LS Means Zygel achieved statistically significant separation from placebo in Social Avoidance & Irritability subscales

 

 

Zygel Advantages Observed in Social Avoidance Are Supported by Caregiver and Clinical Global Impression Improvements in FMet Group * Statistically significant ** Not specific to Social Avoidance 23 Primary Endpoint: ABC - C FXS Social Avoidance Subscale • Statistically significantly improvement vs. placebo (p=0.020*) Caregiver Global Impression – Change at Week 12 (Four Domains) • Statistically significant improvement vs. placebo in Social Interactions (p=0.002*) • Statistically significant improvement vs. placebo in Irritable & Disruptive Behaviors (p=0.028*) • Statistically significant improvement vs. placebo in Social Avoidance & Isolation (p=0.038*) • Trend toward statistical significance in improvement in Overall Behavior vs. placebo (p=0.052) Clinical Global Impression - Improvement** (anchored to FXS behaviors; clinician rated) • Trend toward statistical significance vs. placebo ( p =0.056) Clinically Meaningful Improvements in ABC - C FXS Subscales at Week 12 • Significantly more patients achieved a clinically meaningful change in ABC - C FXS Social Avoidance (≥3 points; p=0.031*) and Irritability (≥9 points; P=0.036*) with Zygel vs. Placebo

 

 

CONNECT - FX: Safety 24 • Zygel was very well tolerated • Safety profile consistent with previously released data from all other Zygel trials • No safety signal identified • No serious or severe adverse events reported during the study • All treatment - emergent adverse events (TEAEs; any event, whether unrelated or related to study drug) were mild or moderate • Most common treatment - related TEAE: application site pain • Zygel: 6.4%; placebo: 1.0% • Seven total psychiatric disorder TEAEs; 5 were in placebo group • Laboratory values for chemistry and hematology comparable between placebo and Zygel groups; no clinically relevant abnormalities in either group • No clinically significant changes to liver function tests

 

 

Next Steps in Fragile X Program 25 • In 4Q2020, Zynerba expects to announce the outcome of its meeting with the FDA and the regulatory path forward in FMet patients • Additional data to be published and presented at upcoming medical meetings

 

 

26 Autism Spectrum Disorder (ASD) in children and adolescents

 

 

ASD in Pediatrics Overview 27 • Near - rare disorder affecting ~1MM pediatric and adolescent patients • Symptoms include • Irritability • Anxiety • Restricted, repetitive patterns of behavior • Impairments in social communication • Deficits in verbal and non - verbal communication • Deficits in developing, understanding and maintaining relationships • Most diagnosed after age 4; can be diagnosed as early as age 2 ௗ • Significant unmet medical need • Accelerating rate of diagnosis but only two FDA approved products • Both atypical antipsychotics have significant side effect profile • Neither approved to address the key symptoms of social impairment and anxiety

 

 

Rationale for Developing Zygel in ASD 28 • Newer studies suggest ASD is linked to disruption in the EC system • Altered anandamide signaling may contribute to ASD - related social and communication impairments • EC system modulates many cellular functions and molecular pathways altered in ASD: imbalanced GABAergic, glutamatergic transmission, oxidative stress, immune dysregulation and altered energy metabolism • Clinical and anecdotal data demonstrate that children dosed with Cannabidiol displayed an improvement in social avoidance and anxiety • May modulate the EC system and improve certain autism - related behaviors • Two recent US patents directed to methods of treating ASD by transdermally administering synthetic or purified cannabidiol , respectively, provide IP protection to 2038

 

 

BRIGHT Phase 2 Trial in ASD 29 Open - La B el Tole R ab I lity and Efficacy Study of ZYN002 Administered as a Transdermal G el to C H ildren and Adolescen T s with Autism Spectrum Disorder 37 patients enrolled Three through 17 years of age Screening Zygel 14 Weeks Weight based dosing: 14 Weeks: COMPLETE 250 mg to 500 mg daily • Aberrant Behavior Checklist (ABC - C) • Parent Rated Anxiety Scale – Autism Spectrum Disorder (PRAS - ASD) • Autism Parenting Stress Index • Autism Impact Measure (AIM) Positive Topline Data Reported on May 27, 2020 24 Weeks Open label extension • Clinical Global Impression – Improvement (CGI - I) and Severity (CGI - S) • Qualitative Caregiver Reported Behavioral Problems Survey Efficacy assessments (primary efficacy assessment = week 14 vs baseline) :

 

 

Baseline Patient Population: BRIGHT Patients enrolled (n) 37 Included in safety analysis 37 Included in efficacy analyses 36* Discontinuations 9 Patients completing 14 - week trial 28 BRIGHT Trial Patient Populations 30 * One patient was lost to follow up and did not have post - dosing efficacy assessments

 

 

Baseline Patient Demographics Patients enrolled, n 37 Age, years Mean (range) 9.2 (3 - 16) Sex, n (%) Male Female 34 (91.9%) 3 (8.1%) Race, % White Asian Native Hawaiian or othe r Pacific Island Other 70.3% 8.1% 2.7% 18.9% Time to diagnosis, years 5.4 Underlying medication, % Subjects entering with ≥1 underlying medication Subjects entering with ≥1 underlying psychotropic medication ( includes anti - depressants, anxiolytics and antipsychotics) 92% 65% BRIGHT Trial Patient Demographics 31

 

 

• Well tolerated; consistent with previously released data • Fewer than half of patients experienced an adverse event (AE); most were mild and transient • Only 14% of patients experienced a treatment - related AE • All application site - related • No severe or serious AEs reported during the study. 32 Strong Safety and Tolerability Profile in BRIGHT Trial in ASD

 

 

33 0 5 10 15 20 25 30 35 40 45 Irritability Inappropriate Speech Stereotypy Social withdrawal Hyperactivity Baseline: 30.3 Baseline: 12.3 Baseline: 7.4 Baseline: 37.0 Baseline: 25.1 39.1% 42.5% 35.6% 36.4% 42.6% Mean % Improvement from Baseline 39.1% * Statistically significant p<0.0001* Statistical Significance Achieved in All Subscales ABC - C Subscales p<0.0001* p<0.0001* p<0.0001* P=0.0002* Percent Improvement in ABC - C Subscale Scores at Week 14 vs. Baseline

 

 

Results of other efficacy assessments support the results demonstrated in the ABC - C, including: • Parent Rated Anxiety Scale - Autism Spectrum Disorder (PRAS - ASD): • Mean improvement of 46% at week 14 from baseline (p<0.0001) • Clinical Global Impression - Improvement (CGI - I) • 57% of patients were rated by clinician as Very Much or Much Improved at week 14 34 ABC - C Responses Supported by Other Efficacy Assessments

 

 

35 Statistically Significant Improvements in Autism Impact Measure Scores 44.0 39.3 31.2 54.0 33.9 29.9 32.7 25.4 36.4 30.4 0 10 20 30 40 50 60 Atypical Behavior Communication Peer Interaction Repetitive Behavior Social Reciprocity AIM Scale Score 34.1% ( P <0.001) 19.7% ( P <0.001) 19.8% ( P <0.001) 32.8% ( P <0.001) 10.7% ( P= 0.0053) Data reported at the 2020 Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting Phase 2 BRIGHT Trial Autism Impact Measure (AIM)

 

 

36 Statistically Significant Improvement: in Autism Parenting Stress Index Additional improvements in the Qualitative Caregiver Behavioral Problems Survey Phase 2 BRIGHT Trial Autism Parenting Stress Index 38.9% ( P <0.0001) 36.0 22.9 0 5 10 15 20 25 30 35 40 APSI Baseline Week 14 Mean APSI Score About the same 31% Improved 69% About the same 34% Improved 63% Worsened 3% About the same 28% Improved 72% Behavioral Social Emotional Data reported at the 2020 Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting

 

 

Next Steps in ASD Program 37 • Zynerba Intends to discuss the results of the Phase 2 BRIGHT trial and the path forward with the FDA in 1H2021 • Present additional data at future medical meetings

 

 

22q11.2 Deletion Syndrome (22q) 38

 

 

22q Overview 39 • Most common contiguous gene deletion syndrome • Rare disorder: ~81K patients in US • Midline condition with abnormalities affecting palate, face, heart and other organs; surgically corrected in infancy • Neuropsychiatric illnesses (anxiety disorders, ASD) and learning disabilities common and impactful • 22q associated with increased anxiety, withdrawn behavior and social interaction problems • Early onset of neuropsychiatric symptoms disrupts development and quality of life, and heightens risk of later psychotic disorders • 25 - fold increased risk of developing schizophrenia vs. 1% lifetime risk in general population

 

 

22q Patient Management 40 • Two primary stages of 22q patient management: • During infancy, doctors address acute physical concerns, such as anomalies of heart and palate, with surgery • Once the physical concerns are stabilized, focus shifts to managing neuropsychiatric symptoms, such as anxiety and autistic behaviors • No currently approved drugs indicated for 22q

 

 

Rationale for Developing Zygel in 22q 41 • Cannabidiol may treat neuropsychiatric symptoms in 22q due to activity as: • Modulator of endocannabinoid system • Agonist at serotonin 1A receptors • Antagonist at GPR55 receptors • Early control of anxiety may delay the development of psychosis • Phase 2 study underway in pediatric and adolescent patients with 22q • Enrollment delayed due to COVID - 19 travel restrictions in Australia; topline results timeline to be announced following lifting of restrictions • Orphan Drug designation received for Cannabidiol for treatment of 22q

 

 

INSPIRE Phase 2 Trial in 22q 42 Target: 20 patients Six through 17 years of age Screening Zygel 14 Weeks Weight based dosing: 14 Weeks 250 mg to 500 mg daily Efficacy assessments (week 14 vs baseline) include: • Aberrant Behavior Checklist - Community (ABC - C) • Anxiety, Depression and Mood Scale (ADAMS) • Qualitative Caregiver Reported Behavioral Problem Survey • Clinical Global Impression – Severity and Improvement Assessing the I mpact of Zygel (Tra ns dermal Cannabidiol Gel) on P ediatr i c Behavio r al and E motional Symptoms of 22q11.2 Deletion Syndrome Enrollment Ongoing 24 Weeks Open label extension

 

 

DEE Developmental and Epileptic Encephalopathies 43

 

 

DEE Patients are Medically Fragile 44 • Group of rare / ultra rare childhood - onset epilepsies with impaired or regressed developmental progress • Cognitive impairment, psychiatric problems, and behavioral disturbances are phenotypic • Medically fragile population • Comorbidities include cerebral palsy, chronic respiratory infections, gait disturbances, movement disorders, scoliosis, and feeding problems • Includes wheelchair bound individuals with feeding tubes • Most common and debilitating seizure types in DEEs are: • Focal impaired - awareness seizures (FIAS) – formerly known as complex partial • Focal to bilateral tonic - clonic and generalized tonic - clonic seizures (TCS) – commonly known as convulsive seizures (CS)

 

 

BELIEVE Phase 2 Trial in DEE 45 Open La B el Study to Assess the Safety and E fficacy of ZYN002 Administered as a Transderma L Gel to Ch I ldren and Adol E scents with De V elopmental and E pileptic Encephalopathy 48 patients enrolled Three through 17 years of age Screening Maintenance 22 Weeks Titration 4 Weeks Open label extension Weight based dosing: Six months Six months Zygel 250 mg to 1000 mg daily Completed; Reported Positive Topline Results on 9/18/19

 

 

46 BELIEVE: Clinically Meaningful Seizure Reductions from Baseline and Sustained through Six Months in DEE 0 10 20 30 40 50 60 70 Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Median Percent Reduction from Baseline, FIAS and CS N=33 N=33 N=33 N=32 N=32 N=29 16% 44% 44% 47% 58% 51% Median Percent Reduction % % % % % % %

 

 

BELIEVE: Percentage of Patients with ≥35% and ≥50% Reduction in FIAS and TCS 47 Data reported at the 2020 American Academy of Neurology (AAN) Science Highlights Virtual Session ≥35% and ≥50% Reduction in FIAS and TCS by Time Point, mITT Population With FIAS and/or TCS at Baseline (n = 33)

 

 

48 • All events in six month period, whether unrelated or related to study drug, reported as adverse AEs (e.g.: influenza, runny nose, scrapes, etc.) • As a result and as anticipated, most patients experienced an AE • Most were mild and transient • Only one patient discontinued due to an AE (application site reaction) • Most common treatment - related adverse events occurred in only four patients each: • Application site dryness, application site pain, and somnolence (all four patients exhibiting somnolence were taking concomitant clobazam ) • Low rate of serious adverse events (SAEs) • Only two SAEs deemed possibly drug - related (LRTI and status epilepticus) • No drug - related hepatic, gastrointestinal, or lethargy - related SAEs • Tolerability profile consistent with the safety database for Zygel BELIEVE Safety Zygel Well Tolerated in this Six Month Trial: No Safety Signal Identified

 

 

49 BELIEVE: Qualitative Assessments of Behavioral and Cognitive Improvements • Epilepsy and Learning Disabilities Quality of Life (ELDQOL) scale • Statistically significant reductions from baseline in subscale scores for seizure severity, behavior, and mood observed at month 6 (p<0.01) • Qualitative caregiver feedback on improvements included: • Any improvement: 84% (n = 36) • Improved vitality: 58% (n = 25) • Improvement in seizures: 51% (n = 22) • Improved cognition/concentration: 47% (n = 20) • Improved socially avoidant behaviors: 44% (n = 19) • Improvement in irritability: 33% (n = 14) • School improvement: 28% (n = 12) • Medical improvement: 14% (n = 6) Data reported at the 2020 American Academy of Neurology (AAN) Science Highlights Virtual Session

 

 

50 BELIEVE: Qualitative Assessments of Behavioral and Cognitive Improvements • Good Day/Bad Day comparing baseline to month six: • “Good day” and “fantastic day” reports increased from 52% to 70% • “Terrible day” and “bad day” reports decreased from 12% to 4% Data reported at the 2020 American Academy of Neurology (AAN) Science Highlights Virtual Session

 

 

51 • Efficacy results: • Clinically meaningful reductions in seizures beginning in month two and sustained through six months • Suggest improvements on important behavioral symptoms • Safety results: • Zygel was well tolerated • Consistent with previously reported Zygel studies • The FDA supports a development program which would treat focal - impaired awareness and convulsive seizures • Due to the heterogeneity of DEE patients, FDA suggests pursuing individual syndromes rather than considering DEE as a single condition • The Company is evaluating specific DEE syndromes as possible clinical targets; expect to provide update around year - end 2020 Compelling Results Suggest a Potential Pathway to Pivotal Trials

 

 

Financial Strength 52 • Clean balance sheet • No debt, 29.4 M shares outstanding (as of November 5, 2020) • Cash and cash equivalent position of $64.3M as of September 30, 2020 • Cash runway expected to be sufficient to fund operations and capital requirements until late in the fourth quarter of 2021

 

 

Expected Clinical Milestones in 2020 53 FXS DEE Report pivotal CONNECT - FX topline results ASD * 22q 1Q 2020 2Q 2020 Report Ph. 2 BRIGHT topline results 3Q 2020 4Q 2020 Results of FDA discussions on clinical path Discuss results in FMet pts with FDA & disclose outcome Enrollment delayed due to COVID - 19 travel restrictions in Australia. Topline results timeline to be determined following lifting of restrictions Provide update on path forward around Y/E 2020 *Note: Zynerba Intends to discuss the results of the Phase 2 BRIGHT trial and the path forward with the FDA in 1H2021

 

 

Corporate Overview November 2020