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Zynerba Pharmaceuticals Reports Second Quarter 2016 Financial Results and Organizational Changes
Dr.
Zynerba announced that
Zynerba also announced the appointment of
“During the quarter, Zynerba achieved several clinical milestones and strengthened the organization. We achieved a significant milestone with our lead development compound, ZYN002, including initiation of a Phase 2 clinical study in epilepsy patients. We are also pleased to welcome two new additions to our executive management team.
Mr. Anido continued, “We deeply appreciate Rick Baron’s numerous contributions, particularly his leadership through our listing on the Nasdaq in
Clinical Highlights from the Second Quarter 2016
Initiated Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial for ZYN002 CBD gel in refractory epilepsy: Zynerba initiated the baseline phase of the STAR 1clinical study in refractory epilepsy patients with focal seizures in June. The Company announced in August that patients had begun randomization and dosing. The STAR 1 trial expects to enroll up to 180 refractory epilepsy patients who will receive either 97.5 mg of ZYN002 4.2% CBD gel, 195 mg of ZYN002 4.2% CBD gel, or placebo gel twice daily. The primary endpoint will assess the median percentage change in seizure frequency over the 12-week treatment period. Safety and tolerability will also be evaluated. Top line results are expected to be reported in the first half of 2017.
Reported top line results from a 7-day Phase 1 Multiple Rising Dose trial for ZYN002 CBD gel: The 7-day Phase 1 trial included 24 healthy volunteers ranging from 25 to 53 years old and 12 epilepsy patients from 19 to 65 years old. These results confirmed that ZYN002 CBD gel was safe and well-tolerated at all dose levels ranging from 200 to 500 mg CBD daily in 1% and 2.5% ZYN002 formulations.
Reported top line results from a 14-day Phase 1 Multiple Rising Dose trial for ZYN002 CBD gel: In this trial, 42 healthy volunteers received a range of CBD doses from 395 mg to 504 mg daily in 2.5% and 4.2% ZYN002 formulations for 14 days. ZYN002 was safe and very well tolerated with minimal skin erythema. The 4.2% formulation demonstrated a comparable pharmacokinetic and tolerability profile to the 2.5% concentration and was easier to use due to its lower volume.
Reported final results from a Phase 1 Single Rising Dose trial: These results confirmed initial findings that ZYN002 CBD gel was safe and well tolerated in healthy volunteers and patients with epilepsy across a wide range of doses.
Anticipated 2016 Clinical Milestones
ZYN002, synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery
- Zynerba plans to initiate additional Phase 2 trials in osteoarthritis (OA) and Fragile X syndrome (FXS) in the second half of 2016.
ZYN001, pro-drug of THC that enables transdermal delivery via patch
- In the second half of 2016, Zynerba expects to initiate Phase 1 studies to evaluate the PK profile and tolerability of ZYN001 in healthy volunteers.
Second Quarter 2016 Financial Results
As of
Research and development expenses for the second quarter of 2016 were
Financial Outlook
Based on current operating plans, the Company expects that its existing cash and cash equivalents will fund its research and development programs and operations through 2017, which will include Phase 2 top line results for the five indications being evaluated for ZYN002 and ZYN001.
About
Non-GAAP Financial Measures
The non-GAAP financial information contained herein is a supplement to the corresponding financial measures prepared in accordance with accounting principles generally accepted in
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the
ZYNERBA PHARMACEUTICALS, INC. | |||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||
(Unaudited) | |||||||||||||||||||
Three months ended | Six months ended | ||||||||||||||||||
June 30, 2016 |
June 30, 2015 | June 30, 2016 |
June 30, 2015 | ||||||||||||||||
Revenue | $ | - | $ | 15,390 | $ | 7,250 | $ | 30,218 | |||||||||||
Operating expenses: | |||||||||||||||||||
Research and development | 4,807,177 | 1,010,989 | 7,376,167 | 1,864,693 | |||||||||||||||
General and administrative | 1,476,357 | 631,474 | 3,156,487 | 1,285,247 | |||||||||||||||
Total operating expenses | 6,283,534 | 1,642,463 | 10,532,654 | 3,149,940 | |||||||||||||||
Loss from operations | (6,283,534 | ) | (1,627,073 | ) | (10,525,404 | ) | (3,119,722 | ) | |||||||||||
Other income (expense): | |||||||||||||||||||
Interest income | 18,118 | 697 | 30,496 | 1,377 | |||||||||||||||
Foreign exchange loss | (20,250 | ) | - | (43,398 | ) | ||||||||||||||
Total other income (expense) | (2,132 | ) | 697 | (12,902 | ) | 1,377 | |||||||||||||
Loss before income taxes | (6,285,666 | ) | (1,626,376 | ) | (10,538,306 | ) | (3,118,345 | ) | |||||||||||
Income tax benefit | (56,277 | ) | - | (27,543 | ) | - | |||||||||||||
Net loss | $ | (6,229,389 | ) | $ | (1,626,376 | ) | $ | (10,510,763 | ) | $ | (3,118,345 | ) | |||||||
Net loss per share - basic and diluted | $ | (0.70 | ) | $ | (1.12 | ) | $ | (1.19 | ) | $ | (2.15 | ) | |||||||
Basic and diluted weighted average shares outstanding | 8,860,592 | 1,449,865 | 8,842,271 | 1,449,865 | |||||||||||||||
ZYNERBA PHARMACEUTICALS, INC. | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
(Unaudited) | |||||||||
June 30, 2016 | December 31, 2015 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 32,133,048 | $ | 41,513,060 | |||||
Incentive and tax receivables | 1,692,315 | 356,718 | |||||||
Prepaid expenses and other current assets | 1,768,994 | 1,545,917 | |||||||
Total current assets | 35,594,357 | 43,415,695 | |||||||
Property and equipment, net | 209,287 | 227,646 | |||||||
Other assets | 200 | 200 | |||||||
Total assets | $ | 35,803,844 | $ | 43,643,541 | |||||
Liabilities and Stockholders' Equity | |||||||||
Current Liabilities: | |||||||||
Accounts payable | $ | 2,681,122 | $ | 823,401 | |||||
Accrued expenses | 1,517,048 | 2,272,991 | |||||||
Deferred grant revenue | 833,975 | 841,225 | |||||||
Total current liabilities | 5,032,145 | 3,937,617 | |||||||
Stockholders' equity: | |||||||||
Common stock | 9,200 | 9,200 | |||||||
Additional paid-in capital | 63,853,317 | 62,276,779 | |||||||
Accumulated deficit | (33,090,818 | ) | (22,580,055 | ) | |||||
Total stockholders' equity | 30,771,699 | 39,705,924 | |||||||
Total liabilities and stockholders' equity | $ | 35,803,844 | $ | 43,643,541 | |||||
ZYNERBA PHARMACEUTICALS, INC. | |||||||||||||||||
RECONCILIATION OF ADJUSTED EBITDA | |||||||||||||||||
(Unaudited) | |||||||||||||||||
Three months ended | Six months ended | ||||||||||||||||
June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | ||||||||||||||
GAAP Net loss | $ | (6,229,389 | ) | $ | (1,626,376 | ) | $ | (10,510,763 | ) | $ | (3,118,345 | ) | |||||
Add back: | |||||||||||||||||
Depreciation | 13,892 | 3,095 | 27,450 | 4,542 | |||||||||||||
Interest income | (18,118 | ) | (697 | ) | (30,496 | ) | (1,377 | ) | |||||||||
Income tax benefit | (56,277 | ) | - | (27,543 | ) | - | |||||||||||
EBITDA | (6,289,892 | ) | (1,623,978 | ) | (10,541,352 | ) | (3,115,180 | ) | |||||||||
Add back: | |||||||||||||||||
Stock-based compensation | 812,739 | - | 1,576,538 | - | |||||||||||||
Foreign exchange loss | 20,250 | - | 43,398 | - | |||||||||||||
Adjusted EBITDA | $ | (5,456,903 | ) | $ | (1,623,978 | ) | $ | (8,921,416 | ) | $ | (3,115,180 | ) | |||||
Investor ContactsRichard Baron , CFOZynerba Pharmaceuticals 484.581.7505 baronr@zynerba.comKimberly Minarovich Argot Partners 212.600.1902 kimberly@argotpartners.com Media ContactEliza Schleifstein Argot Partners 973.361.1546 eliza@argotpartners.com