"We are also taking steps to further capitalize the Company and simplify its capital structure. In October 2016, we launched a tender offer to amend and exercise the warrants issued to investors in connection with our 2014 private placement offer," continued Mr. Fayad. "We believe that this warrant tender offer will assist the Company's growth plans and will position Enumeral to attract new investors in potential future financing transactions. We sincerely appreciate the continued support of our stockholders and other stakeholders, and we look forward to reporting on our progress in the months ahead."Recent Business Highlights
- In September 2016, Wael Fayad was appointed Chairman, Chief Executive Officer and President of Enumeral. Mr. Fayad brings more than two decades of senior executive and business development experience in the life sciences industry. Previously, Mr. Fayad spent 14 years at Forest Laboratories, Inc., where he held positions of increasing responsibility, most recently as Corporate Vice President, Global Business Development.
- Enumeral is continuing to pursue its pipeline of antibody candidates, including its PD-1 antibody program. The Company has selected one of its lead anti-PD-1 antibody candidates, known as ENUM 244C8, for further development.
- A recent study in the reconstituted human immune system NSG mouse found that ENUM 244C8 treatment resulted in a significant reduction in growth of the lung patient derived tumor LG1309.
- Following on these data, Enumeral has initiated a second anti-tumor efficacy study in the HuGEMM PD-1 mouse model that will evaluate an ENUM 244C8 dose response for anti-tumor efficacy.
- The Company has also initiated a dose response safety study with ENUM 244C8 in non-human primates with dosing planned before the end of the fourth quarter 2016.
- Enumeral intends to partner these assets and is pursuing potential transactions with respect to these antibody programs.
- Cash and cash equivalents: Cash and cash equivalents were $1,893,414 as of September 30, 2016, as compared to $3,596,262 as of December 31, 2015. As of the date of this press release, Enumeral believes that it only has sufficient liquidity to fund operations into December 2016. The Company is continuing to explore a range of potential transactions, which may include public or private equity offerings, debt financings, collaborations and licensing arrangements, and/or other strategic alternatives, including a merger, sale of assets or other similar transactions. If Enumeral is unable to raise additional capital on acceptable terms and on a timely basis, Enumeral may be required to downsize or wind down its operations through liquidation, bankruptcy, or a sale of its assets.
- Collaboration and license revenue. Collaboration and license revenue decreased by $169,333, or 43%, to $226,115 for the three months ended September 30, 2016, as compared to $395,448 for the three months ended September 30, 2015. This decrease in revenue is primarily attributable to a decrease in research and development activities related to the Company's collaboration study agreement with Merck.
- Grant revenue. Grant revenue increased by $6,319, or 7%, to $94,696 for the three months ended September 30, 2016, as compared to $88,377 for the three months ended September 30, 2015. This increase is attributable to the Company's Phase II Small Business Innovation Research agreement with the National Cancer Institute.
- Research and development expenses. Research and development expenses decreased by $771,924, or 43%, to $1,026,317 for the three months ended September 30, 2016, as compared to $1,798,241 for the three months ended September 30, 2015. This decrease is primarily attributable to a decrease of $317,474 in wages and benefits associated with lower headcount, a decrease of $238,529 in lab expenses associated with reduced research and development activities, a decrease of $88,681 in patent costs, and a decrease of $56,415 in consulting costs.
- General and administrative expenses. General and administrative expenses decreased by $541,090, or 40%, to $812,974 for the three months ended September 30, 2016, as compared to $1,354,064 for the three months ended September 30, 2015. This decrease was primarily attributable to (i) a decrease of $427,306 in wages and benefits associated with lower headcount, (ii) a decrease of $45,316 in consulting costs and (iii) a decrease of $32,164 in travel and entertainment costs, offset by an increase of $130,927 in stock-based compensation expense resulting from one-time charges associated with the departure of two of the Company's executives and options granted during the nine months ended September 30, 2016.
- Other income (expense). Other income (expense) decreased by $3,029,134, or 92%, to $257,630 for the three months ended September 30, 2016, as compared to $3,286,764 for the three months ended September 30, 2015. This decrease is primarily due to a decrease of $2,871,515 in non-cash income related to the change in the fair value of derivative liabilities primarily associated with the warrants issued in connection with the Company's July 2014 private placement transaction and a change of $157,619 in interest income (expense) primarily related to interest expense associated with the Company's 12% Senior Secured Promissory Notes. The Company expects that future changes in the fair value of the derivative liabilities will be due primarily to fluctuations in the value of the Company's common stock and potential exercises of outstanding warrants.
- Net Income (loss). Net income (loss) changed by $1,879,134, or 304%, to ($1,260,850) for the three months ended September 30, 2016, as compared to $618,284 for the three months ended September 30, 2015. This change was primarily due to a decrease of $2,871,515 in the change in the fair value of derivative liabilities and a decrease of $163,014 in revenue, offset by a decrease of $1,313,014 in operating expenses.
More detailed information about Enumeral and risk factors that may affect the realization of forward-looking statements, including forward-looking statements in this press release, is set forth in Enumeral's filings with the Securities and Exchange Commission (the "Commission"). Enumeral urges investors and security holders to read those documents free of charge at the Commission's website at http://www.sec.gov. Forward-looking statements speak only as to the date they are made, and except for any obligation under the U.S. federal securities laws, Enumeral undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.
|Enumeral Biomedical Holdings, Inc.|
|Condensed Consolidated Balance Sheets|
|September 30,||December 31,|
|Cash and cash equivalents||$||1,893,414||$||3,596,262|
|Other current assets||478,923||586,491|
|Total current assets||2,372,337||4,182,753|
|Property and equipment, net||1,031,192||1,511,493|
|LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)|
|Total current liabilities||4,720,701||3,567,223|
|Other long term liabilities||136,268||303,318|
|Total stockholders' equity (deficiency)||(807,104||)||2,473,057|
|Total liabilities and stockholders' equity (deficiency)||$||4,049,865||$||6,343,598|
|Enumeral Biomedical Holdings, Inc.|
|Condensed Consolidated Statements of Operations|
|Three Months Ended September 30,|
|Collaboration and license revenue||$||226,115||$||395,448|
|Cost of revenue and expenses:|
|Research and development||1,026,317||1,798,241|
|General and administrative||812,974||1,354,064|
|Total cost of revenue and expenses||1,839,291||3,152,305|
|Loss from operations||(1,518,480||)||(2,668,480||)|
|Other income (expense):|
|Interest income (expense)||(152,261||)||5,358|
|Change in fair value of derivative liabilities||409,891||3,281,406|
|Total other income (expense), net||257,630||3,286,764|
|Net income (loss) before income taxes||(1,260,850||)||618,284|
|Provision for income taxes||-||-|
|Net income (loss)||$||(1,260,850||)||$||618,284|
|Income (loss) per common share:|
|Weighted-average number of common shares outstanding:|