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): June 6, 2016

Enumeral Biomedical Holdings, Inc.

(Exact name of registrant as specified in its charter)

(617) 945-9146

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

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:

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

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

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

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

On June 6, 2016, Enumeral Biomedical Holdings, Inc. (with its subsidiaries, “Enumeral” or the “Company”) entered into a Definitive License and Transfer Agreement (the “Definitive Agreement”) with Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH (collectively, “Pieris”), as contemplated in the License and Transfer Agreement that the Company and Pieris entered into on April 18, 2016 (the “License Agreement”). Pieris also paid Enumeral a $750,000 license maintenance fee due by May 31, 2016 to continue the licensing arrangements under the License Agreement. In accordance with its terms, the Definitive Agreement supersedes the License Agreement.

The Definitive Agreement continues the non-exclusive, royalty-bearing worldwide license Enumeral has granted Pieris under specified Enumeral patent rights and know-how to research, develop and market fusion proteins that comprise a moiety derived from Enumeral’s 388D4 anti-PD-1 antibody linked to one or more Pieris Anticalin^® proteins for use in the field of oncology. Enumeral has agreed not to conduct, or assist third parties in conducting, activities that involve an antibody licensed under the Definitive Agreement fused with or linked to one or more Anticalin proteins in the field of oncology.

Under the Definitive Agreement, Enumeral has granted Pieris an option until May 31, 2017 to license specified Enumeral patent rights and know-how covering two additional undisclosed Enumeral antibody programs on the same terms and conditions as for Enumeral’s 388D4 anti-PD-1 antibody (each, a “Subsequent Option”). Pieris may exercise the Subsequent Antibody Options separately and on different dates during the Option Period. Pieris will pay Enumeral additional undisclosed license fees in the event that Pieris exercises one or both Subsequent Options.

The sales and milestone payments and royalty provisions set forth in the Definitive Agreement remain the same as those set forth in the License Agreement. Under the Definitive Agreement, Pieris agrees to pay Enumeral development milestones of up to an aggregate of $37.8 million upon the achievement of specified events, as well as net sales milestone payments of up to an aggregate of $67.5 million upon the achievement of specified net sales thresholds.  Pieris also agrees to pay Enumeral royalties in the low-to-lower middle single digits as a percentage of net sales depending on the amount of net sales in the applicable years.  In the event that Pieris is required to pay a license fee or royalty to any third party due to incorporation of Enumeral antibody moiety in the licensed products, the royalty payment due to Enumeral shall be reduced by the amount of such third party fees or payments, up to 50% of the royalty payment for each calendar year due to Enumeral. In the event that Pieris licenses one or both of the additional antibodies pursuant to a Subsequent Option, any resulting fusion protein products will be subject to additional royalties and development and sales milestones in the same amounts applicable to the fusion proteins linking the licensed PD-1 antibody and one or more Anticalin proteins.  

Pursuant to the terms of the Definitive Agreement, Enumeral will indemnify Pieris Indemnitees (as defined in the Definitive Agreement) against certain claims specified therein, including with respect to breaches of representations and warranties, as well as claims by the Massachusetts Institute of Technology and other specified entities who are parties to an agreement with Enumeral. In addition, Pieris will indemnify Enumeral Indemnitees (as defined in the Definitive Agreement) against certain claims specified therein, including with respect to breaches of representations and warranties, as well as with respect to the development, commercialization, manufacture or use of any Product before or after Marketing Authorization (as such terms are defined in the Definitive Agreement). The Definitive Agreement also contains customary representations and warranties for both Enumeral and Pieris.

The term of the Definitive Agreement ends upon the expiration of the last to expire patent included in the Definitive Agreement. The Definitive Agreement may be terminated by Pieris on 30 days’ notice and by Enumeral upon 60 days’ notice of a material breach by Pieris (or 30 days with respect to a breach of payment obligations by Pieris), provided that Pieris has not cured such breach and that dispute resolution procedures specified in the Definitive Agreement have been followed.

The foregoing summary of the Definitive Agreement does not purport to be complete and is qualified in its entirety by reference to the Definitive Agreement, a copy of which will be filed as an exhibit to Enumeral’s Quarterly Report on Form 10-Q for the period ending June 30, 2016. Enumeral intends to seek confidential treatment for certain portions of the Agreement.

Enumeral has previously reported that it has sufficient liquidity to fund operations through June 2016. As of the date of this filing, Enumeral believes that, with the receipt of the $750,000 maintenance fee from Pieris described above, the Company now has sufficient liquidity to fund operations through July 2016. The Company will still require additional capital to continue its operations through the third quarter of 2016. The Company continues 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 the Company is unable to preserve or raise additional capital through one or more of such transactions prior to the end of July 2016, the Company could face substantial liquidity problems and might be required to implement cost reduction strategies. In addition, the Company may be required to downsize or wind down its operations through liquidation, bankruptcy, or a sale of its assets.

Item 8.01 Other Events.

On June 6, 2016, Enumeral issued a press release announcing that Enumeral had entered into the Definitive Agreement described in Item 1.01 above. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

SIGNATURES

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.

        ENUMERAL BIOMEDICAL HOLDINGS, INC.

Dated: June 6, 2016

By: /s/ Kevin G. Sarney

Name: Kevin G. Sarney

Title: Vice President of Finance, Chief Accounting Officer and Treasurer

EXHIBIT INDEX