Eleven Biotherapeutics Reports Second Quarter 2016 Financial Results and Provides Strategic Update
"We look forward to closing our licensing deal with Roche, contingent upon the approval of our stockholders at our upcoming stockholder meeting," said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics.
Recent Business Highlights and Strategic Update:
Submitted an Investigational New Drug (IND) application to the
U.S. Food and Drug Administration(FDA) to initiate clinical trials of EBI-031, a humanized monoclonal antibody that potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6 signaling, for the treatment of ocular diseases such as diabetic macular edema and uveitis.
Signed an exclusive license agreement with
F. Hoffmann-La Roche Ltd.and Hoffmann-La Roche Inc.(Roche) relating to Eleven's IL-6 technology. Under the terms of the agreement, Eleven has agreed to grant an exclusive, worldwide license to Roche to develop and commercialize EBI-031, and all other IL-6 antagonist antibody technology owned by Eleven. Under the agreement, Eleven will be entitled to an upfront payment of $7.5 million, along with potential future milestone payments of up to $262.5 million. Effectiveness of the license agreement is subject to approval of the license by holders of at least a majority of the outstanding shares of Eleven's common stock.
Announced that the IND application for EBI-031 became effective. As a
result of the achievement of this milestone, Eleven is entitled to
$22.5 millionpayment from Roche pursuant to the terms of its license agreement with Roche, subject to stockholder approval of the license.
- Continue to engage in a process to review a range of strategic alternatives with the goal of maximizing stockholder value. Potential strategic alternatives that Eleven may continue to explore and evaluate during the ongoing review process include, among others, the sale of the Company, a strategic partnership or a business combination with one or more parties or the licensing, sale or divestiture of some of the Company's assets or proprietary technologies that are not related to the license agreement with Roche. As part of the strategic review process, or if the strategic review process does not result in any additional transaction, Eleven may also consider a distribution to stockholders of all or a portion of the payments from Roche under the license agreement.
Second Quarter 2016 Financial Results:
- Revenue: Revenue was $0.3 million for the three months ended June 30, 2016, compared to $0.1 million for the same period in 2015.
- R&D Expenses: Research and development expenses were $3.3 million for the three months ended June 30, 2016, compared to $6.3 million for the same period in 2015. This decrease was primarily due to lower development expenses related to our product candidate Isunakinra, which development activities are no longer ongoing, partially offset by higher EBI-031 related development expenses.
- G&A Expenses: General and administrative expenses were $3.5 million for the three months ended June 30, 2016, compared to $2.2 million for the same period in 2015. This increase was primarily due to higher professional fees related to the license agreement with Roche and our review of strategic alternatives.
- Net Loss: Net loss applicable to common stockholders was $6.5 million, or $0.33 per share, for the three months ended June 30, 2016, compared to net loss applicable to common stockholders of $6.9 million, or $0.36 per share, for the same period in 2015.
Cash and Cash Equivalents: Cash and cash equivalents were $8.5
million as of June 30, 2016. We believe that our current cash and cash
equivalents, together with the aggregate upfront and initial milestone
payments of approximately
$30 millionthat will be due and payable within 30 days after effectiveness of the license agreement with Roche, will be sufficient to fund our current operating plans into 2017.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the potential
effectiveness of the license agreement with Roche or receipt of payments
thereunder, the future rights and obligations of the parties under the
license agreement, the Company's strategy, future operations,
advancement or maturation of its product candidates and product
pipeline, clinical development of the Company's product candidates,
including expectations regarding timing of regulatory submissions and
initiation of clinical trials, regulatory requirements for initiation of
clinical trials and registration of product candidates, the review of
its strategic alternatives and the outcome of such review, the
completion and results of potential strategic transactions, the
sufficiency of its cash resources 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
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Three Months Ended
Six Months Ended
|Research and development||3,298||6,269||7,930||11,507|
|General and administrative||3,471||2,247||5,618||4,850|
|Total operating expenses||6,769||8,516||13,548||16,357|
|Loss from operations||(6,492||)||(8,402||)||(13,042||)||(15,999||)|
|Other income (expense), net||1||1,496||(1,023||)||2,569|
Net loss per share applicable to common stockholders—
Weighted-average number of common shares used in net loss per
share applicable to common stockholders—basic and diluted
ELEVEN BIOTHRAPEUTICS, INC.
CONDENSED BALANCE SHEETS
|Cash and cash equivalents||$||8,484||$||36,079|
|Prepaid expenses and other current assets||350||232|
|Total current assets||8,834||36,311|
|Property and equipment, net||314||407|
|Liabilities and stockholders' equity|
|Notes payable, current portion||-||4,134|
|Total current liabilities||3,008||7,580|
|Notes payable, net of current portion||-||9,763|
|Additional paid-in capital||145,420||144,126|
|Total stockholders' equity||6,173||18,944|
|Total liabilities and stockholders' equity||$||9,267||$||36,825|
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