Preliminary Data from Phase 3 VISTA Trial in Bladder Cancer to be Presented During Plenary Session at American Urological Association Annual Meeting; Company to Host Conference Call in Conjunction with Data Presentation in May 2018
Expected Operating Runway Extended into the First Quarter of 2019
Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, today reported key pipeline progress and operating results for the quarter and year ended December 31, 2017.
“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 Eleven Biotherapeutics. “We recently completed enrollment in our Phase 3 VISTA trial, and we are pleased that initial data from the first patients in the VISTA trial were selected for an oral presentation at the American Urological Association Annual Meeting. 2018 is set to be a transformative year, and with the completion of our recent equity financing, we are capitalized to continue advancing Vicinium. We look forward to assessing its efficacy and safety in NMIBC, and exploring opportunities to expand its utility in other indications and in combination regimens.”
Recent Pipeline and Corporate Highlights
Upcoming Data Presentations
Fourth Quarter and Full-Year 2017 Financial Results
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 Eleven Biotherapeutics, EpCAM has been shown to be overexpressed in non-muscle invasive bladder cancer (NMIBC) cells with minimal to no EpCAM expression observed on normal bladder cells. Eleven Biotherapeutics is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Topline, three-month data from the trial are expected in mid-2018. Additionally, Eleven Biotherapeutics believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a late-stage clinical company advancing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer based on the company’s Targeted Protein Therapeutics platform. The company’s lead program, Vicinium™, is currently in a Phase 3 registration trial for the treatment of non-muscle invasive bladder cancer, with topline data expected in mid-2018. Vicinium incorporates a tumor-targeting antibody fragment and a protein cytotoxic payload into a single protein molecule designed to selectively and effectively kill cancer cells while sparing healthy cells. For more information, please visit 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 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 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.
| 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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