Eleven Biotherapeutics Reports Third Quarter 2016 Financial Results

Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeting Protein Therapeutics (TPTs) platform, today reported financial results for the third quarter ended September 30, 2016, and recent business highlights.

"This is an exciting period for Eleven. We completed the Roche licensing deal, including $30 million in upfront and milestone payments received to date. We also completed the acquisition of Viventia Bio Inc. which allowed us to become a late-stage oncology company. Perhaps most excitingly, we are making significant progress in moving forward what we believe could be therapeutics that materially improve patients' lives. We anticipate complete enrollment in the first half of next year for our Phase 3 clinical trial of Vicinium™ as a potential treatment for high-grade non-muscle invasive bladder cancer, and expect topline data in the first half of 2018," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. "We also plan to initiate our Phase 2 trial in late-stage squamous cell carcinoma of the head and neck with Proxinium in combination with a checkpoint inhibitor in the first half of 2017. Also in 2017, we plan on submitting an IND with the FDA for our lead product in our systemic pipeline based on our proprietary payload deBouganin. With the combined expertise of Eleven and the Viventia team, I am very excited about the opportunities we have ahead."

Third Quarter and Recent Business Highlights:
  • Completed acquisition of Viventia Bio Inc., creating a company focused on the development of novel therapies based upon antibody fragments genetically fused to cytotoxic proteins, or TPTs, as new treatments in areas of oncology. Eleven's pipeline now includes Viventia's lead product candidates Vicinium and Proxinium. Both product candidates are anti-EpCAM (epithelial cell adhesion molecule) fusion proteins that have been optimized for local tumor administration.
    • Vicinium is in a Phase 3 clinical trial for high grade non-muscle invasive bladder cancer (NMIBC) with topline data expected in the first half of 2018. In a Phase 2 clinical trial, Vicinium demonstrated a complete response rate of 40% at three months with no patients discontinuing treatment due to treatment related serious adverse events. To date, Vicinium has been evaluated in more than 100 patients in previously completed clinical trials.
    • Proxinium is expected to enter a Phase 2 clinical trial in combination with a checkpoint inhibitor in the first half of 2017 for the treatment of late-stage squamous cell carcinoma of the head and neck. In previous clinical trials, Proxinium was generally well-tolerated and showed signs of anti-tumor activity. Proxinium has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and Fast Track designation from the FDA.
  • Completed exclusive License Agreement with Roche for IL-6 antagonist antibody technology, including EBI-031. Eleven granted Roche an exclusive, worldwide license to develop and commercialize EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven. Eleven has received $30 million in payments from Roche, including a $7.5 million upfront payment in connection with the effectiveness of the License agreement, and a $22.5 million milestone payment based on the IND application for EBI-031 becoming effective. Under the terms of the License Agreement, Eleven could receive up to an additional $240 million upon the achievement of certain future regulatory, development and commercialization milestones. In addition, Eleven is entitled to receive royalties based on net sales of potential future products containing EBI-031 or any other potential future products containing other Eleven IL-6 compounds.

Third Quarter 2016 Financial Results:
  • Revenue: Revenue was $28.7 million for the three months ended September 30, 2016, compared to $0.1 million for the same period in 2015. The increase was due to the revenue recognized from the License Agreement with Roche.
  • R&D Expenses: Research and development expenses were $2.8 million for the three months ended September 30, 2016, compared to $6.7 million for the same period in 2015. The decrease was primarily due to a decrease of isunakinra-related development expenses, for which development activities are no longer ongoing, as well as decreases in EBI-031 related development expenses due to the License Agreement with Roche.
  • G&A Expenses: General and administrative expenses were $6.4 million for the three months ended September 30, 2016, compared to $2.7 million for the same period in 2015. The increase was primarily due to increased severance, retention and stock-based compensation expenses and professional fees related to our review of strategic alternatives and the acquisition of Viventia.
  • Net Income (Loss): Net income was $19.5 million, or $0.95 per basic share and $0.91 per diluted share, for the three months ended September 30, 2016, compared to a net loss of $9.7 million, or $0.50 per basic and diluted share, for the same period in 2015. The change was primarily the result of the revenue recognized from the License Agreement with Roche.
  • Cash and Cash Equivalents: Cash and cash equivalents were $30.7 million as of September 30, 2016. We believe that our cash and cash equivalents as of September 30, 2016 will enable us to fund our operating expenses into 2018.

Events and Presentations:
  • Protein & Antibody Engineering Summit (PEGS) Europe, October 31-November 4, 2016 in Lisbon, Portugal.
  • European Antibody Congress, November 14-16, 2016 in Basel, Switzerland.

Conference Call Information:

Eleven Biotherapeutics' management team will host a conference call and audio webcast today at 8:30 a.m. ET to discuss the third quarter 2016 results and provide a corporate update. To access the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) at least five minutes prior to the start time and refer to conference ID 14447038.

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