Press Release
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Zynerba Pharmaceuticals Reports First Quarter 2016 Financial Results and Operational Highlights
“We continue to make rapid progress in our ZYN002 cannabidiol (CBD) gel clinical development program with positive initial results reported in a Phase 1 single rising dose trial, the initiation of a second Phase 1 trial in healthy volunteers and patients with epilepsy, and a grant of orphan drug designation from the
“Further, important in vitro data were published in
Highlights from the First Quarter 2016 and Recent Developments
Reported Positive Initial Results from a Phase 1 Single Rising Dose Trial and Initiated a Phase 1 Multiple Rising Dose Trial of ZYN002 CBD Gel: In
ZYN002 Granted Orphan Drug Designation for Fragile X Syndrome: In
Data Published Demonstrating the Degradation of Orally Administered Cannabidiol to Psychoactive Cannabinoids when Exposed to Simulated Gastric Fluid: In
Anticipated 2016 Milestones
ZYN002, synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery
- By the end of the first half of 2016, Zynerba expects to report final results from its ongoing Phase 1 single rising dose clinical trial, including results from 12 patients with epilepsy.
- By the end of the first half of 2016, Zynerba expects to report results from its second ongoing Phase 1 multiple rising dose clinical trial.
- Pending the results of the Phase 1 trials, Zynerba plans to initiate Phase 2 trials in refractory epilepsy, osteoarthritis (OA), and 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 and patients with fibromyalgia.
First Quarter 2016 Financial Results
As of
Research and development expenses for the first 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 data readout for the five indications of 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
Management uses adjusted EBITDA (defined as earnings before interest, income taxes, depreciation, amortization, stock-based compensation and foreign currency loss) in its evaluation of the Company's core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Management believes that this non-GAAP financial information reflects an additional way of viewing aspects of our business that, when viewed with our GAAP results, provide a more complete understanding of factors and trends affecting our business. Please see the section of this press release titled “Reconciliation of Adjusted EBITDA and Adjusted EBITDA Per Share.”
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 | ||||||||
| March 31, 2016 | March 31, 2015 | |||||||
| Revenues | $ | 7,250 | $ | 14,828 | ||||
| Operating expenses: | ||||||||
| Research and development | 2,568,989 | 853,704 | ||||||
| General and administrative | 1,680,130 | 653,773 | ||||||
| Total operating expenses | 4,249,119 | 1,507,477 | ||||||
| Loss from operations | (4,241,869 | ) | (1,492,649 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 12,377 | 680 | ||||||
| Foreign currency loss | (23,148 | ) | - | |||||
| Total other income (expense) | (10,771 | ) | 680 | |||||
| Loss before income taxes | (4,252,640 | ) | (1,491,969 | ) | ||||
| Income tax expense | 28,734 | - | ||||||
| Net loss | $ | (4,281,374 | ) | $ | (1,491,969 | ) | ||
| Net loss per share - basic and diluted | $ | (0.49 | ) | $ | (1.03 | ) | ||
| Basic and diluted weighted average shares outstanding | 8,823,951 | 1,449,865 | ||||||
| ZYNERBA PHARMACEUTICALS, INC. | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (Unaudited) | ||||||||
| March 31, 2016 | December 31, 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 36,809,693 | $ | 41,513,060 | ||||
| Incentive receivable | 356,718 | 356,718 | ||||||
| Prepaid expenses and other current assets | 1,359,890 | 1,545,917 | ||||||
| Total current assets | 38,526,301 | 43,415,695 | ||||||
| Property and equipment, net | 223,180 | 227,646 | ||||||
| Other assets | 352,980 | 200 | ||||||
| Total assets | $ | 39,102,461 | $ | 43,643,541 | ||||
| Liabilities and Stockholders' Equity (Deficit) | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 989,414 | $ | 823,401 | ||||
| Accrued expenses | 1,090,724 | 2,272,991 | ||||||
| Deferred grant revenue | 833,974 | 841,225 | ||||||
| Total current liabilities | 2,914,112 | 3,937,617 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock | 9,200 | 9,200 | ||||||
| Additional paid-in capital | 63,040,578 | 62,276,779 | ||||||
| Accumulated deficit | (26,861,429 | ) | (22,580,055 | ) | ||||
| Total stockholders' equity (deficit) | 36,188,349 | 39,705,924 | ||||||
| Total liabilities and stockholders' equity (deficit) | $ | 39,102,461 | $ | 43,643,541 | ||||
| ZYNERBA PHARMACEUTICALS, INC. | ||||||||
| RECONCILIATION OF ADJUSTED EBITDA AND ADJUSTED EBITDA PER SHARE | ||||||||
| (Unaudited) | ||||||||
| Three months ended | ||||||||
| March 31, 2016 | March 31, 2015 | |||||||
| GAAP Net loss | $ | (4,281,374 | ) | $ | (1,491,969 | ) | ||
| Add back: | ||||||||
| Depreciation | 13,558 | 1,447 | ||||||
| Interest (income) | (12,377 | ) | (680 | ) | ||||
| Income tax expense | 28,734 | - | ||||||
| EBITDA | (4,251,459 | ) | (1,491,202 | ) | ||||
| Add back: | ||||||||
| Stock-based compensation | 763,799 | - | ||||||
| Foreign currency loss | 23,148 | - | ||||||
| Adjusted EBITDA | $ | (3,464,512 | ) | $ | (1,491,202 | ) | ||
| GAAP Net loss per share | $ | (0.49 | ) | $ | (1.03 | ) | ||
| Add back: | ||||||||
| Depreciation | 0.00 | 0.00 | ||||||
| Interest (income) expense | (0.00 | ) | (0.00 | ) | ||||
| Income tax expense | 0.01 | - | ||||||
| EBITDA per share | (0.48 | ) | (1.03 | ) | ||||
| Add back: | ||||||||
| Stock-based compensation | 0.09 | - | ||||||
| Foreign currency loss | 0.00 | - | ||||||
| Adjusted EBITDA per share | $ | (0.39 | ) | $ | (1.03 | ) | ||
| Shares used in computation of GAAP and | ||||||||
| adjusted EBITDA per share - basic and diluted | 8,823,951 | 1,449,865 | ||||||
Investor ContactsRichard Baron , CFOZynerba Pharmaceuticals 484.581.7505 baronr@zynerba.comAngeli Kolhatkar orKimberly Minarovich Argot Partners 212.600.1902 angeli@argotpartners.com kimberly@argotpartners.com Media ContactEliza Schleifstein Argot Partners 973.361.1546 eliza@argotpartners.com
