Eleven Biotherapeutics Reports Fourth Quarter and Full-Year 2017 Operating Results and Vicinium Development Progress
Preliminary Data from Phase 3 VISTA Trial in Bladder Cancer to be
Presented During Plenary Session at
Expected Operating Runway Extended into the First Quarter of 2019
“2017 was a year of significant developments for our company, and as we
look ahead, I am highly encouraged by what we have already achieved in
2018. Vicinium™, our lead product candidate, holds significant potential
in treating a range of cancers, and is well underway in a registration
trial for people with non-muscle invasive bladder cancer,” said Stephen
Hurly, president and chief executive officer of
Recent Pipeline and Corporate Highlights
-
On
March 23, 2018 ,Eleven Biotherapeutics closed a$10.0 million equity financing priced at-the-market. This financing, coupled with the proceeds from the company’s$8.0 million public offering completed inNovember 2017 , extends the company’s cash runway into the first quarter of 2019 based on its current operating plan. -
In
March 2018 ,Eleven Biotherapeutics announced that enrollment was completed in the company’s Phase 3 VISTA trial evaluating its lead product candidate, Vicinium, for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG). -
In
December 2017 , a trial at theUS National Cancer Institute (NCI) of Vicinium in combination withAstraZeneca's immune checkpoint inhibitor, Imfinzi® (durvalumab), for the treatment of NMIBC opened. -
In
September 2017 ,Eleven Biotherapeutics completed the manufacturing of all Vicinium necessary for its ongoing trials.
Upcoming Data Presentations
- Present Preclinical Data at AACR:
Eleven Biotherapeutics will present preclinical data from its deBouganin program at the 2018American Association for Cancer Research (AACR) Annual Meeting during two poster sessions. The company’s systemically administered product candidates are designed using its proprietary de-immunized variant of the plant-derived cytotoxin bouganin, deBouganin. Details of the presentations are as following:- Poster Title: VB6-845d Tumor Cell Killing Elicits Biologic
Features of Immunogenic Cell Death
- Date and Time:
April 16, 2018 from1:00 to 5:00 p.m. CT
- Date and Time:
- Poster Title: Engineering and Characterization of Anti-PSMA
Humabody-DeBouganin Fusion Proteins
- Date and Time:
April 18, 2018 from8:00 a.m. to 12:00 p.m. CT
- Date and Time:
- Poster Title: VB6-845d Tumor Cell Killing Elicits Biologic
Features of Immunogenic Cell Death
- Present Data from Phase 3 VISTA Trial at AUA Annual Meeting:
Eleven Biotherapeutics will present the first, topline data from its Phase 3 VISTA trial of Vicinium in patients with NMIBC who have been previously treated with BCG during a plenary session at this year’sAmerican Urological Association Annual Meeting being held inSan Francisco . The data being presented are three-month data from an initial 75 patients in the trial. Details of the presentation are as follows:- Presentation Title: Phase 3 Study of Vicinium in
BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Initial
Results
- Date and Time:
Monday, May 21, 2018 at11:00 a.m. PT
- Date and Time:
- Presentation Title: Phase 3 Study of Vicinium in
BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Initial
Results
Fourth Quarter and Full-Year 2017 Financial Results
- Cash Position: Cash and cash equivalents were
$14.7 million as ofDecember 31, 2017 , compared to$25.3 million as ofDecember 31, 2016 , a decrease of$10.6 million , which was primarily driven by$17.6 million in cash used by operating activities plus,$0.1 million in capital expenditures, partially offset by$7.1 million in cash provided through theNovember 2017 underwritten public offering. - Revenue: No revenue was recognized during the three months
ended
December 31, 2017 , compared to$0.8 million for the same three-month period in 2016. Revenue was$0.4 million for the twelve months endedDecember 31, 2017 , compared to$30.0 million for the same period in 2016. The decrease was primarily due to a decrease in license revenue as we recognized the upfront license fee and development milestone payment under the license agreement withRoche , relating to the execution of the license agreement and the successful submission of the IND application for EBI-031 during 2016, as well as a decrease in collaboration revenue from a terminated collaboration. - R&D Expenses: Research and development expenses were
$3.1 million for the three months endedDecember 31, 2017 , compared to$2.8 million for the same period in 2016. For the twelve months endedDecember 31, 2017 research and development expenses were$12.5 million compared to$13.5 million for the 2016 fiscal year. The decrease of$1.0 million was primarily due to a decrease in EBI-031 related development expenses of$3.0 million due to the license agreement withRoche in whichRoche is responsible for all on-going development expenses, as well as a decrease of$1.7 million of isunakinra-related development expenses, which development activities are no longer ongoing. These decreases were partially offset by increases in Vicinium-related development expenses of$5.4 million , since the company’s acquisition ofViventia Bio Inc. (Viventia) inSeptember 2016 . - G&A Expenses: General and administrative expenses were
$2.0 million for the three months endedDecember 31, 2017 , compared to$2.8 million for the same period in 2016. For the twelve months endedDecember 31, 2017 general and administrative expenses were$8.1 million compared to$14.7 million for fiscal 2016. The decrease of$6.7 million was primarily due to a reduction of professional fees as well as salaries and related costs for personnel, including stock-based compensation. For the year endedDecember 31, 2016 , the company had higher professional fees related to the license agreement withRoche , the company’s 2016 review of strategic alternatives and the acquisition of Viventia. In addition, for the year endedDecember 31, 2016 , the company recorded higher severance costs related to the acquisition of Viventia. - Net Income (Loss): Net loss was
$6.6 million , or$0.22 per share, for the three months endedDecember 31, 2017 , compared to net loss of$3.5 million , or$0.15 per share, for the same period in 2016. Net loss was$29.0 million , or$1.11 per share, for the twelve months endedDecember 31, 2017 , compared to net income of$1.9 million , or$0.09 per share, for the same period in 2016. Fiscal 2016 was benefited by approximately$30.0 million in revenue under the company’s license agreement withRoche while no comparable revenue was recognized during fiscal 2017. - Financial Guidance: Following Eleven Biotherapeutics’ recent
$10.0 million equity financing inMarch 2018 , the company expects to have capital to fund its current operating plans into the first quarter of 2019; however, we have based this estimate on assumptions that may prove to be wrong, and our capital resources may be utilized faster than we currently expect.
About Vicinium™
Vicinium™, Eleven Biotherapeutics’ lead product candidate, is a
next-generation antibody-drug conjugate (ADC) developed using the
company’s proprietary Targeted Protein Therapeutics platform. Vicinium
is comprised of a recombinant fusion protein that targets epithelial
cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to
deliver a potent protein payload, Pseudomonas Exotoxin A (ETA).
Vicinium is constructed with a stable, genetically engineered peptide
linker to ensure the payload remains attached until it is internalized
by the cancer cell, which is believed to decrease the risk of toxicity
to healthy tissues, thereby improving its safety. In prior clinical
studies conducted by
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 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
additional capital to continue to fund operations 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
ELEVEN BIOTHERAPEUTICS, INC. | ||||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||||||||
2017 |
2016 |
2017 |
2016 |
|||||||||||||||||||
Total revenue | $ | - | $ | 825 | $ | 425 | $ | 29,981 | ||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Research and development | 3,108 | 2,795 | 12,510 | 13,479 | ||||||||||||||||||
General and administrative | 1,985 | 2,752 | 8,070 | 14,736 | ||||||||||||||||||
Loss (gain) from change in fair value of contingent consideration | 1,500 | (1,100 | ) | 9,100 | (1,100 | ) | ||||||||||||||||
Total operating expenses | 6,593 | 4,447 | 29,680 | 27,115 | ||||||||||||||||||
Loss (gain) from operations | (6,593 | ) | (3,622 | ) | (29,255 | ) | 2,866 | |||||||||||||||
Other income (expense), net | 46 | 96 | 226 | (970 | ) | |||||||||||||||||
Net (loss) income before income taxes | (6,547 | ) | (3,526 | ) | (29,029 | ) | 1,896 | |||||||||||||||
Provision for income taxes | - | 5 | - | 5 | ||||||||||||||||||
Net (loss) income and comprehensive (loss) income | $ | (6,547 | ) | $ | (3,531 | ) | $ | (29,029 | ) | $ | 1,891 | |||||||||||
Net (loss) income per share —basic | $ | (0.22 | ) | $ | (0.15 | ) | $ | (1.11 | ) | $ | 0.09 | |||||||||||
Weighted-average number of common shares used in net (loss) income per share —basic |
30,385 | 24,296 | 26,105 | 21,083 | ||||||||||||||||||
Net (loss) income per share —diluted | $ | (0.22 | ) | $ | (0.15 | ) | $ | (1.11 | ) | $ | 0.09 | |||||||||||
Weighted-average number of common shares used in net (loss) income per share —diluted |
30,385 | 24,296 | 26,105 | 21,733 | ||||||||||||||||||
ELEVEN BIOTHERAPEUTICS, INC. | |||||||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||||||
(in thousands) | |||||||||||||
December 31, | |||||||||||||
2017 | 2016 | ||||||||||||
Assets | |||||||||||||
Current assets: | |||||||||||||
Cash and cash equivalents | $ | 14,680 | $ | 25,342 | |||||||||
Prepaid expenses and other current assets | 301 | 585 | |||||||||||
Total current assets | 14,981 | 25,927 | |||||||||||
Property and equipment, net | 522 | 796 | |||||||||||
Restricted cash | 10 | 10 | |||||||||||
Intangible assets | 46,400 | 60,500 | |||||||||||
Goodwill | 13,064 | 16,864 | |||||||||||
Other assets | 120 | - | |||||||||||
Total assets | $ | 75,097 | $ | 104,097 | |||||||||
Liabilities and stockholders' equity | |||||||||||||
Current liabilities: | |||||||||||||
Accounts payable | $ | 907 | $ | 1,667 | |||||||||
Accrued expenses | 3,813 | 1,774 | |||||||||||
Deferred revenue | - | 425 | |||||||||||
Due to related party | - | 114 | |||||||||||
Total current liabilities | 4,720 | 3,980 | |||||||||||
Other liabilities | 215 | - | |||||||||||
Warrant liability | - | 5 | |||||||||||
Deferred tax liability | 12,528 | 16,335 | |||||||||||
Contingent consideration | 39,600 | 45,100 | |||||||||||
Stockholders' equity: | |||||||||||||
Common stock | 35 | 25 | |||||||||||
Additional paid-in capital | 170,330 | 161,963 | |||||||||||
Accumulated deficit | (152,331 | ) | (123,311 | ) | |||||||||
Total stockholders' equity | 18,034 | 38,677 | |||||||||||
Total liabilities and stockholders' equity | $ | 75,097 | $ | 104,097 |
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Source:
THRUST
Monique Allaire, 617-895-9511
monique@thrustir.com
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Alicia
Davis, 910-620-3302
alicia@thrustir.com