Full Press Release Details
Eleven Biotherapeutics Reports Fourth Quarter and Year-End 2014 Financial Results
Management to host conference call today at 8:30 a.m. EST
Cambridge, MA, March 4, 2015 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 fourth quarter and full year ended December 31, 2014.
made significant progress advancing our pipeline of novel protein therapeutics for eye disease including our lead product candidate, EBI-005, which is in late-stage clinical development for dry eye disease and allergic conjunctivitis. said
Abbie Celniker, Ph.D., President and Chief Executive Officer. We completed patient enrollment in our pivotal Phase 3 clinical study for EBI-005 in patients with moderate to severe dry eye disease and expect to report top-line results from that
study in the second quarter of 2015. One of the requirements for regulatory approval and an important milestone for the pivotal clinical program was the initiation of a twelve-month safety study with EBI-005 in dry eye disease. We also reported
encouraging Phase 2 top-line safety and efficacy results for EBI-005 in patients with moderate to severe allergic conjunctivitis, further validating EBI-005 as a clinically active anti-inflammatory ocular agent. In addition to the progress made with
EBI-005 we are also pleased with the progress that we have made with our second product candidate in development for diabetic macular edema with a planned IND filing by the end of 2015.
Fourth Quarter and Recent Business Highlights:
Year-End 2014 Financial Results
Upcoming Events and Presentations:
Conference Call Information:
Eleven Biotherapeutics management team will host a conference call and audio webcast today at 8:30 a.m. EST to discuss the fourth quarter and year-end
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 87544666.
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.
Eleven 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.
Eleven Biotherapeutics most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME, We designed and engineered
EBI-031 for intravitreal delivery using our AMP-Rx platform. EBI-005 is a potent blocker of both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R) and has a longer vitreal retention time than antibodies and antibody like molecules
approved for intra-vitreal injection. We are undertaking the necessary CMC development work and nonclinical safety studies to support the submission of an investigational new drug application, or IND, to the FDA by the end of 2015 for the purpose of
conducting clinical trials of EBI-031
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.
Cautionary Note on Forward-Looking Statements
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 November 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 December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Collaboration revenue | $ | 375 | $ | 510 | $ | 2,243 | $ | 1,334 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,258 | 3,212 | 26,703 | 13,788 | ||||||||||||
| General and administrative | 2,212 | 1,418 | 8,471 | 4,024 | ||||||||||||
| Total operating expenses | 7,470 | 4,630 | 35,174 | 17,812 | ||||||||||||
| Loss from operations | (7,095 | ) | (4,120 | ) | (32,931 | ) | (16,478 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Other expense, net | (905 | ) | (51 | ) | (849 | ) | (147 | ) | ||||||||
| Interest expense, net | (139 | ) | (895 | ) | (376 | ) | (1,400 | ) | ||||||||
| Total other expense | (1,044 | ) | (946 | ) | (1,225 | ) | (1,547 | ) | ||||||||
| Net loss | $ | (8,139 | ) | $ | (5,066 | ) | $ | (34,156 | ) | $ | (18,025 | ) | ||||
| Cumulative preferred stock dividends | (1,142 | ) | (519 | ) | (3,857 | ) | ||||||||||
| Net loss applicable to common stockholders | $ | (8,139 | ) | $ | (6,208 | ) | $ | (34,675 | ) | $ | (21,882 | ) | ||||
| Net loss per share applicable to common stockholders basic and diluted | $ | (0.49 | ) | $ | (4.29 | ) | $ | (2.37 | ) | $ | (16.18 | ) | ||||
| Weighted-average number of common shares used in net loss per share applicable to common stockholders basic and diluted | 16,692 | 1,447 | 14,644 | 1,352 |
ELEVEN BIOTHRAPEUTICS, INC.
CONDENSED BALANCE SHEETS
| December 31, | ||||||||
| 2014 | 2013 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 54,059 | $ | 7,942 | ||||
| Prepaid expenses and other current assets | 342 | 88 | ||||||
| Total current assets | 54,401 | 8,030 | ||||||
| Property and equipment, net | 486 | 759 | ||||||
| Restricted cash | 94 | 94 | ||||||
| Other assets | 19 | 2,354 | ||||||
| Total assets | $ | 55,000 | $ | 11,237 | ||||
| Liabilities, convertible preferred stock, and stockholders equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,458 | $ | 1,746 | ||||
| Accrued expenses | 1,987 | 850 | ||||||
| Notes payable, current portion | 251 | 1,642 | ||||||
| Deferred revenue, current portion | 506 | 1,115 | ||||||
| Total current liabilities | 5,202 | 5,353 | ||||||
| Deferred revenue, net of current portion | 355 | |||||||
| Restricted stock liability | 4 | 10 | ||||||
| Notes payable, net of current portion | 9,749 | 2,876 | ||||||
| Warrant liability | 3,219 | 297 | ||||||
| Series A convertible preferred stock | 45,035 | |||||||
| Series B convertible preferred stock | 11,643 | |||||||
| Stockholders equity (deficit): | ||||||||
| Preferred stock | ||||||||
| Common stock | 18 | 2 | ||||||
| Additional paid-in capital | 128,558 | 3,260 | ||||||
| Accumulated deficit | (91,750 | ) | (57,594 | ) | ||||
| Total stockholders equity (deficit) | 36,826 | (54,332 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders equity (deficit) | $ | 55,000 | $ | 11,237 |