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Eleven Biotherapeutics Reports Third Quarter 2017 Financial ResultsEleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, today reported financial results for the quarter ended September 30, 2017. "I am very pleased with our progress this quarter. In addition to strengthening our balance sheet with a successful public offering in November, we also made strong progress during this quarter on our Phase 3 clinical trial examining Vicinium™ in patients with non-muscle invasive bladder cancer (NMIBC)," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. "We are driving our Phase 3 enrollment forward and expect to achieve full enrollment in Q1 2018. The Company also remains on track to report top-line three-month data from our registration trial in mid-2018 with sufficient capital to carry us through this critical milestone. Also, we are excited that the combination trial of Vicinium™ and durvalumab, Astra Zeneca's checkpoint inhibitor, has opened at the National Cancer Institute and we will be gathering immune biomarker data that we believe will provide insight into the complementary mechanism of action between checkpoint inhibitors and our TPT platform." Third Quarter Results, Recent Business Highlights and Anticipated Upcoming Milestones: Vicinium™ is a single protein anti-epithelial cell adhesion molecule (anti-EpCAM) antibody fragment fused with Pseudomonas Exotoxin A (ETA) that is designed to specifically target and deliver a potent anti-cancer payload directly into tumor cells. Vicinium™ is currently in a Phase 3 registration clinical trial for the treatment of high-grade NMIBC in subjects who have previously received two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. The company also has a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) evaluating Vicinium™ in combination with AstraZeneca's checkpoint inhibitor, durvalumab.
Corporate:
TPT Pipeline: Eleven's pipeline includes additional locally delivered product candidates, as well as a systemic TPT platform.
The Company has deferred further development of Proxinium™ and VB6-84d in order to focus its efforts and resources on the advancement of its Phase 3 registration trial of Vicinium™. The Company is also exploring partnering and collaboration strategies to move these additional product candidates forward. Third Quarter 2017 Financial Results:
About Eleven Biotherapeutics: Eleven Biotherapeutics, Inc. is a late-stage, clinical oncology company advancing novel product candidates based upon the Company's targeted protein therapeutics (TPTs) platform. The Company's TPTs incorporate a tumor-targeting antibody fragment and a cytotoxic protein payload within a single protein molecule in order to achieve focused tumor cell killing. The Company believes its TPT approach offers significant advantages in treating cancer over existing antibody drug conjugate technologies. The Company believes its TPTs provide effective tumor targeting with broader cancer cell-killing properties than generally achievable with small molecule cytotoxic payloads that require tumor cell proliferation to be effective and can face challenges overcoming multi-drug resistance mechanisms within tumor cells. Additionally, the Company believes that its TPT's cancer cell-killing properties promote an anti-tumor immune response that will potentially combine well with immune oncology drugs such as checkpoint inhibitors. For more information, please refer to the Company's website at www.elevenbio.com. Cautionary Note on Forward-Looking Statements: Any statements in this press release about future expectations, plans and prospects for the Company, the Company's strategy, future operations, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the occurrence of any event change or other circumstances that could give rise to the termination of the License Agreement (License Agreement) with F. Hoffmann-La Roche Ltd and Hoffman (News - Alert)-La Roche Inc., the uncertainties inherent in receiving future payments pursuant to the License Agreement, the uncertainties inherent in the initiation and conduct of clinical trials, our ability to successfully develop our product candidates and complete our planned clinical programs, our ability to obtain marketing approvals for our product candidates, expectations regarding our ongoing clinical trials, availability and timing of data from clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical studies will be indicative of the results of future studies, the adequacy of any clinical models, expectations regarding regulatory approvals, our ability to obtain, maintain and protect our intellectual property for our technology and products, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company's projected use of proceeds from its November 2017 public offering, other matters that could affect the financial performance of the Company, other matters that could affect the availability or commercial potential of the Company's product candidates and other factors discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.
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