Eleven Biotherapeutics Reports Third Quarter 2016 Financial Results
-Management to host conference call today at
"This is an exciting period for Eleven. We completed the Roche licensing
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
$30 millionin payments from Roche, including a $7.5 millionupfront payment in connection with the effectiveness of the License agreement, and a $22.5 millionmilestone 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 millionupon 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
$0.91per 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, 2016in Lisbon, Portugal.
European Antibody Congress, November 14-16, 2016in Basel, Switzerland.
Conference Call Information:
Eleven Biotherapeutics' management team will host a conference call and
audio webcast today at
An audio webcast of the call will also be available on the Investors & Media section of the company's website, www.elevenbio.com. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.
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, 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, 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 and Quarterly Reports on Form 10-Q filed with the
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
Three Months Ended
Nine Months Ended
|Research and development||2,754||6,745||10,684||18,252|
|General and administrative||6,366||2,681||11,984||7,531|
|Total operating expenses||9,120||9,426||22,668||25,783|
|Income (loss) from operations||19,530||(9,359||)||6,488||(25,358||)|
|Other income (expense), net||(43||)||(334||)||(1,066||)||2,235|
|Net income (loss)||$||19,487||$||(9,693||)||$||5,422||$||(23,123||)|
|Net income (loss) per share —basic||$||0.95||$||(0.50||)||$||0.27||$||(1.23||)|
|Weighted-average number of common shares used in net income|
|(loss) per share —basic||20,495||19,345||20,004||18,806|
|Net income (loss) per share —diluted||$||0.91||$||(0.50||)||$||0.26||$||(1.23||)|
|Weighted-average number of common shares used in net income|
|(loss) per share —diluted||21,423||19,345||20,796||18,806|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||30,716||$||36,079|
|Prepaid expenses and other current assets||952||232|
|Due from related party||50||-|
|Total current assets||31,812||36,311|
|Property and equipment, net||894||407|
|Liabilities and stockholders' equity|
|Due to related party||697||-|
|Other current liabilities||65||-|
|Notes payable, current portion||-||4,134|
|Total current liabilities||6,265||7,580|
|Notes payable, net of current portion||-||9,763|
|Due to related party||117|
|Deferred tax liability||9,774||-|
|Additional paid-in capital||161,201||144,126|
|Total stockholders' equity||41,445||18,944|
|Total liabilities and stockholders' equity||$||79,578||$||36,825|
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