Full Press Release Details
Eleven Biotherapeutics Reports Third Quarter 2014 Financial Results
Management to host conference call today at 8:30 am EST
Cambridge, MA, November 13, 2014 Eleven Biotherapeutics (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing
protein therapeutics to treat diseases of the eye, today reported financial results for the third quarter ended September 30, 2014 and recent business highlights.
We have made good progress advancing our lead product candidate, EBI-005, since the second quarter of this year. We are encouraged by the Phase 2
top-line safety and efficacy results for EBI-005 in patients with moderate to severe allergic conjunctivitis, as we believe these data further validate EBI-005 as a clinically active anti-inflammatory ocular agent. said Abbie Celniker, PhD,
President and Chief Executive Officer. Additionally, we recently completed patient enrollment in our first pivotal Phase 3 study of EBI-005 in patients with dry eye disease and expect to report top-line results of that trial in the second
Recent Business Highlights:
Third Quarter 2014 Financial Results
Conference Call Information:
Biotherapeutics management team will host a conference call and audio webcast today at 8:30 a.m. EST to discuss the third quarter 2014 results and provide a corporate update. To access the conference call, please dial (844) 831-3025
(domestic) or (315) 625-6887 (international) at least five minutes prior to the start time and refer to conference ID 28098475.
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.
Biotherapeutics most advanced product candidate is EBI-005, a novel, topically-administered interleukin-1 (IL-1) receptor blocker in development as a protein therapeutic for dry eye disease and allergic conjunctivitis. The EBI-005 program is
based on the role that elevated levels of the inflammatory cytokine IL-1 play in the initiation and maintenance of the inflammation and pain associated with dry eye disease and the itching and other symptoms associated with allergic conjunctivitis.
EBI-005 has been evaluated in a Phase 2 study in patients with moderate to severe allergic conjunctivitis and is currently being evaluated in a pivotal Phase 3 study in dry eye disease.
About Eleven Biotherapeutics
Eleven Biotherapeutics,
Inc. is a clinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. Eleven s therapeutic
approach is based on the role of cytokines
in diseases of the eye, the company s understanding of the structural biology of cytokines and the company s ability to rationally design and engineer proteins to modulate the effects
of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements
about the Company s strategy, future operations, advancement or maturation of its product candidates and product pipeline, clinical development of the Company s therapeutic candidates, including expectations regarding timing of initiation
of clinical trials, patient enrollment and availability of results, regulatory requirements for initiation of clinical trials and registration of product candidates, sufficiency of 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 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, availability and timing of data from ongoing
clinical trials, whether results of early clinical trials will be indicative of the results of future trials, the adequacy of any clinical models, uncertainties associated with regulatory review of clinical trials and applications for marketing
approvals and other factors discussed in the Risk Factors section of the Company s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 13, 2014 and other reports on file 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
ELEVEN BIOTHERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
thousands, except per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Collaboration revenue | $ | 539 | $ | 622 | $ | 1,868 | $ | 824 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 8,872 | 3,376 | 21,445 | 10,576 | ||||||||||||
| General and administrative | 2,269 | 786 | 6,259 | 2,606 | ||||||||||||
| Total operating expenses | 11,141 | 4,162 | 27,704 | 13,182 | ||||||||||||
| Loss from operations | (10,602 | ) | (3,540 | ) | (25,836 | ) | (12,358 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Other income, net | 2 | 16 | 56 | (96 | ) | |||||||||||
| Interest expense, net | (74 | ) | (289 | ) | (237 | ) | (505 | ) | ||||||||
| Total other expense | (72 | ) | (273 | ) | (181 | ) | (601 | ) | ||||||||
| Net loss | $ | (10,674 | ) | $ | (3,813 | ) | $ | (26,017 | ) | $ | (12,959 | ) | ||||
| Cumulative preferred stock dividends | (905 | ) | (519 | ) | (2,715 | ) | ||||||||||
| Net loss applicable to common stockholders | $ | (10,674 | ) | $ | (4,718 | ) | $ | (26,536 | ) | $ | (15,674 | ) | ||||
| Net loss per share applicable to common stockholders basic and diluted | $ | (0.66 | ) | $ | (3.39 | ) | $ | (1.90 | ) | $ | (11.87 | ) | ||||
| Weighted-average number of common shares used in net loss per share applicable to common stockholders basic and diluted | 16,098 | 1,390 | 13,954 | 1,320 |
ELEVEN BIOTHRAPEUTICS, INC.
CONDENSED BALANCE SHEETS
| September 30, 2014 | December 31, 2013 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 35,943 | $ | 7,942 | ||||
| Prepaid expenses and other current assets | 348 | 88 | ||||||
| Total current assets | 36,291 | 8,030 | ||||||
| Property and equipment, net | 585 | 759 | ||||||
| Restricted cash | 94 | 94 | ||||||
| Other assets | 11 | 2,354 | ||||||
| Total assets | $ | 36,981 | $ | 11,237 | ||||
| Liabilities, convertible preferred stock, and stockholders equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,588 | $ | 1,746 | ||||
| Accrued expenses | 1,656 | 850 | ||||||
| Notes payable, current portion | 1,642 | 1,642 | ||||||
| Deferred revenue, current portion | 621 | 1,115 | ||||||
| Total current liabilities | 6,507 | 5,353 | ||||||
| Deferred revenue, net of current portion | 45 | 355 | ||||||
| Restricted stock liability | 6 | 10 | ||||||
| Notes payable, net of current portion | 1,645 | 2,876 | ||||||
| Warrant liability | 297 | |||||||
| Series A convertible preferred stock | 45,035 | |||||||
| Series B convertible preferred stock | 11,643 | |||||||
| Stockholders equity (deficit): | ||||||||
| Preferred stock | ||||||||
| Common stock | 16 | 2 | ||||||
| Additional paid-in capital | 112,373 | 3,260 | ||||||
| Accumulated deficit | (83,611 | ) | (57,594 | ) | ||||
| Total stockholders equity (deficit) | 28,778 | (54,332 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders equity (deficit) | $ | 36,981 | $ | 11,237 |