Emisphere Reports Third Quarter 2016 Financial Results

ROSELAND, N.J., Nov. 14, 2016 (GLOBE NEWSWIRE) -- Emisphere Technologies, Inc. (OTCBB:EMIS) today reported financial results for the third quarter ended September 30, 2016, and provided an overview of corporate accomplishments and plans.

"To date in 2016, we have made significant progress toward our key corporate objectives of securing a strategic alliance or transaction for Eligen B12 and new oral formulation development partnerships for our innovative Eligen® Technology," said Alan L. Rubino, President and Chief Executive Officer of Emisphere. "Our discussions continue to advance with potential partners, both the U.S. and internationally, for the ongoing global commercialization of oral Eligen B12.  We believe that Eligen B12 is a best-in-class product with a largely untapped patient base."

Mr. Rubino continued, "On the financial front, we significantly reduced our operating expenses versus the same period a year ago, and we continue to look for opportunities to increase efficiency, reduce overhead, and extend our cash runway as we build a strong foundation for 2017."

YEAR TO DATE 2016 HIGHLIGHTS

Exploring Strategic Partnership Opportunities for Oral Eligen B12™ in the U.S. and Internationally.  Eligen B12™ is the first and only once-daily oral prescription medical food tablet shown to normalize B12 levels without the need for an injection.  Eligen B12™ is indicated for the dietary management of patients who have a medically-diagnosed vitamin B12 deficiency, associated with a disease or condition that cannot be managed by a modification of the normal diet alone.  Eligen B12™ utilizes Emisphere's SNAC carrier to chaperone B12 through the gastric lining and directly into the bloodstream even in the absence of intrinsic factor, a protein made in the stomach that normally facilitates B12 absorption.  Emisphere is currently in discussions with several potential partners for a strategic alliance or transaction for Eligen B12™.

Novo Nordisk Commenced Global Phase 3a Clinical Trials for Oral Semaglutide.  During 2016, Novo Nordisk commenced Phase 3a testing for oral semaglutide, which utilizes Emisphere's absorption-enhancing monosodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC) carrier.  Novo Nordisk plans to conduct ten clinical trials enrolling approximately 9,300 patients with Type-2 diabetes in this Phase 3a program.  The advancement of oral semaglutide into Phase 3a development represents a significant milestone for both Emisphere and the Eligen® Technology platform and supports the Company's belief that products developed using Eligen® carriers have the potential to overcome bioavailability challenges commonly associated with the oral administration of peptides and certain other compounds.  Novo Nordisk has stated that data from the oral semaglutide Phase 3a program is expected to be reported beginning in late 2017.

Novo Nordisk Continues Feasibility Studies under our Development and License Agreement to Develop Oral Formulations Targeting Metabolic Indications.  Emisphere and Novo Nordisk entered into a license agreement to develop and commercialize oral formulations of four classes of Novo Nordisk's investigational molecules targeting major metabolic disorders, including diabetes and obesity, using Emisphere's oral Eligen® Technology.  Emisphere received a $5.0 million upfront licensing fee, and is eligible to receive up to $207 million in development and sales milestone payments in addition to royalties on sales of each successfully commercialized product under this agreement.

Global Eligen® Technology Business Development Initiatives Continue.  Emisphere continues to pursue its comprehensive business development initiative designed to identify and secure new Eligen® Technology partnerships.  Eligen® Technology is a proven delivery system technology that is applicable to a broad range of chemical entities and has been shown to increase the benefit of the therapy by improving bioavailability or absorption or by decreasing time to onset of action.  The Company currently owns rights to an extensive portfolio of carriers with strong patent protection.  The current focus of the business development initiative is on next generation, smaller proteins and peptides, proven and/or approved drug compounds, and the development of new oral formulations to replace injectables.

Grant of Waivers and Extensions Under Debt Facility, Convertible Notes and Reimbursement Notes.  During November 2015, the creditor under our Loan Agreement, Convertible Notes and Reimbursement notes agreed to waive any event of default resulting from our failure to satisfy the net sales milestone for the Eligen B12™ product for the 2015 fiscal year specified in our Loan and Royalty Agreements.  We do not anticipate meeting the annual sales target at December 31, 2016, however, the Company is currently in discussions with the creditor for a permanent waiver of this condition.  The creditor has also agreed to extend the date by which we are required to use 50% of the $14 million received from Novo Nordisk to pre-pay certain loans and notes (the "Loan Prepayment") until November 15, 2016.  We believe that our current cash balance will provide sufficient capital to continue operations through November, 2016.  However, if the pre-payment obligation is further extended or waived, the Company will have sufficient cash to operate through December, 2017.

THIRD QUARTER 2016 FINANCIAL RESULTS

Emisphere reported a net loss of $5.2 million, or ($0.09) per basic and diluted share, for the quarter ended September 30, 2016, compared to net loss of $4.4 million, or ($0.07) per basic and diluted share, for the quarter ended September 30, 2015.

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