Eleven Biotherapeutics Reports Fourth Quarter and Full Year 2016 Financial Results
-- Advancing Late-Stage Targeted Protein Therapeutics Pipeline for Treatment of Cancers with High Unmet Medical Need --
-- Completed Integration of
-- Topline Phase 3 Data for Lead Drug Candidate Vicinium™, in Development for Non-Muscle Invasive Bladder Cancer, Expected in 2018 --
- Management to Host Conference Call Today at
"2016 was a transformative year for Eleven. Following our acquisition of
Fourth Quarter and Recent Business Highlights and Anticipated Upcoming Milestones:
Vicinium™: Vicinium is a single protein
anti-epithelial cell adhesion molecule (anti-EpCAM) protein fused with Pseudomonas
Exotoxin A (ETA) 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 non-muscle invasive bladder cancer (NMIBC) in subjects who
have previously received two courses of Bacillus Calmette-Guérin (BCG)
and whose disease is now BCG-unresponsive. Eleven intends to enroll 134
subjects in the trial, including 77 subjects with carcinoma in situ (CIS),
at over 65 centers in
- Complete enrollment for Phase 3 registration clinical trial expected in second half of 2017
- Topline data from Phase 3 registration clinical trial expected in 2018
Proxinium™: Proxinium is a single protein anti-EpCAM antibody fragment fused with ETA for the treatment of late-stage squamous cell carcinoma of the head and neck (SCCHN). Phase 2 data showed observable reductions in target tumor size in 71% of evaluable subjects, as well as tumor growth control in 80% of evaluable subjects presenting with multiple tumors. By generating a host anti-tumor immune response, Proxinium has also demonstrated the potential to improve the efficacy of checkpoint inhibitors.
Proxinium has received Orphan Drug Designation from the
- Initiation of Phase 1/2a clinical trial evaluating Proxinium in combination with a checkpoint inhibitor expected in the second half of 2017
Systemically-administered TPT Pipeline: Eleven's initial systemically-administered TPTs leverage a highly potent, de-immunized, plant toxin, deBouganin. DeBouganin has picomolar killing, has demonstrated multi-drug resistance avoidance, and may potentially induce an effect against cancer stem cells. Its safety profile based upon a prior clinical trial also provides a broad therapeutic window, which suggests deBouganin-based therapies may be effective against a wide spectrum of different cancers.
- Investigational New Drug Application (IND) submission planned for the first quarter of 2018.
Partnered Programs: In
Corporate: In
Fourth Quarter and Full Year 2016 Financial Results:
-
Cash Position: Cash and cash equivalents were
$25.3 million as ofDecember 31, 2016 , compared to$36.1 million as ofDecember 31, 2015 , a decrease of$10.8 million , which was primarily driven by the repayment of the note payable partially offset by cash provided by operations. -
Revenue: Revenue was
$0.8 million for the three months endedDecember 31, 2016 , compared to$0.6 million for the same period in 2015. Revenue was$30.0 million for the twelve months endedDecember 31, 2016 , compared to$1.0 million for the same period in 2015. This increase was related to revenue recognized from the License Agreement with Roche, which was partially offset by reduced fees under the former collaboration agreement with ThromboGenics N.V. -
R&D Expenses: Research and development expenses were
$2.8 million for the three months endedDecember 31, 2016 , compared to$8.1 million for the same period in 2015. The decrease was due primarily 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. These decreases were partially offset by increases in Vicinium-related development expenses. Research and development expenses were$13.5 million for the twelve months endedDecember 31, 2016 , compared to$26.3 million for the same period in 2015. -
G&A Expenses: General and administrative expenses were
$2.8 million for the three months endedDecember 31, 2016 , compared to$2.3 million for the same period in 2015. This increase was due primarily to accounting and legal fees related to the integration of Viventia. General and administrative expenses were$14.7 million for the twelve months endedDecember 31, 2016 , compared to$9.9 million for the same period in 2015. -
Net Income (Loss): Net loss was
$3.5 million , or$0.15 per share, for the three months endedDecember 31, 2016 , compared to net loss of$10.3 million , or$0.53 per share, for the same period in 2015. Net income was$1.9 million , or$0.09 per share, for the twelve months endedDecember 31, 2016 , compared to net loss of$33.5 million , or$1.76 per share, for the same period in 2015. - Financial Guidance: Based on current operating plans, Eleven expects to have cash to fund research and development programs and operations into early 2018.
Upcoming Events and Presentations:
-
American Association for Cancer Research (AACR) Annual Meeting,April 1-5, 2017 inWashington D.C. -
Protein Engineering Summit,
May 1-5, 2017 inBoston, Massachusetts .
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.
About
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, Quarterly Reports on Form 10-Q and other reports
filed with the
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data) |
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Three Months Ended |
Twelve Months Ended |
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| 2016 | 2015 | 2016 | 2015 | ||||||||||||||||||
| Total revenue | $ | 825 | $ | 565 | $ | 29,981 | $ | 990 | |||||||||||||
| Operating expenses: | |||||||||||||||||||||
| Research and development | 2,795 | 8,084 | 13,479 | 26,336 | |||||||||||||||||
| General and administrative | 2,752 | 2,319 | 14,736 | 9,850 | |||||||||||||||||
| (Gain) loss from change in fair value of contingent consideration | (1,100 | ) | - | (1,100 | ) | - | |||||||||||||||
| Total operating expenses | 4,447 | 10,403 | 27,115 | 36,186 | |||||||||||||||||
| Income (loss) from operations | (3,622 | ) | (9,838 | ) | 2,866 | (35,196 | ) | ||||||||||||||
| Other income (expense), net | 96 | (491 | ) | (970 | ) | 1,744 | |||||||||||||||
| Net income (loss) before income taxes | (3,526 | ) | (10,329 | ) | 1,896 | (33,452 | ) | ||||||||||||||
| Provision for income taxes | 5 | - | 5 | - | |||||||||||||||||
| Net income (loss) | $ | (3,531 | ) | $ | (10,329 | ) | $ | 1,891 | $ | (33,452 | ) | ||||||||||
| Net income (loss) per share —basic | $ | (0.15 | ) | $ | (0.53 | ) | $ | 0.09 | $ | (1.76 | ) | ||||||||||
| Weighted-average number of common shares used in net income | |||||||||||||||||||||
| (loss) per share —basic | 24,296 | 19,547 | 21,083 | 18,993 | |||||||||||||||||
| Net income (loss) per share —diluted | $ | (0.15 | ) | $ | (0.53 | ) | $ | 0.09 | $ | (1.76 | ) | ||||||||||
| Weighted-average number of common shares used in net income | |||||||||||||||||||||
| (loss) per share —diluted | 24,296 | 19,547 | 21,733 | 18,993 | |||||||||||||||||
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CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands) |
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| 2016 | 2015 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 25,342 | $ | 36,079 | |||||||
| Prepaid expenses and other current assets | 585 | 232 | |||||||||
| Total current assets | 25,927 | 36,311 | |||||||||
| Property and equipment, net | 796 | 407 | |||||||||
| Restricted cash | 10 | 94 | |||||||||
| Intangible assets | 60,500 | - | |||||||||
|
|
16,864 | - | |||||||||
| Other assets | - | 13 | |||||||||
| Total assets | $ | 104,097 | $ | 36,825 | |||||||
| Liabilities and stockholders' equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 1,667 | $ | 1,246 | |||||||
| Accrued expenses | 1,774 | 1,794 | |||||||||
| Deferred revenue | 425 | 406 | |||||||||
| Due to related party | 114 | - | |||||||||
| Notes payable, current portion | - | 4,134 | |||||||||
| Total current liabilities | 3,980 | 7,580 | |||||||||
| Other liabilities | - | 423 | |||||||||
| Notes payable, net of current portion | - | 9,763 | |||||||||
| Warrant liability | 5 | 115 | |||||||||
| Deferred tax liability | 16,335 | - | |||||||||
| Contingent consideration | 45,100 | - | |||||||||
| Stockholders' equity: | |||||||||||
| Common stock | 25 | 20 | |||||||||
| Additional paid-in capital | 161,963 | 144,126 | |||||||||
| Accumulated deficit | (123,311 | ) | (125,202 | ) | |||||||
| Total stockholders' equity | 38,677 | 18,944 | |||||||||
| Total liabilities and stockholders' equity | $ | 104,097 | $ | 36,825 | |||||||
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