Eleven Biotherapeutics Reports Fourth Quarter and Year-End 2014 Financial Results
Management to host conference call today at
"We 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
Fourth Quarter and Recent Business Highlights:
- Completed patient enrollment in the OASIS study (A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Control in Subjects with Moderate to Severe Dry Eye Disease), our first pivotal Phase 3 clinical study for EBI-005 in patients with dry eye disease. Top-line results are expected in the second quarter of 2015.
- Initiated a twelve-month clinical study in patients with moderate to severe dry eye disease to assess the long-term safety and tolerability of EBI-005 as part of its ongoing pivotal Phase 3 program.
- Reported in October top-line results from our proof of concept Phase 2 clinical trial of EBI-005 in patients with moderate to severe allergic conjunctivitis. In a modified CAPT (conjunctival allergen provocation test) model, patients treated with EBI-005 showed statistically significant improvements in mean change from baseline in patient reported ocular itching, ocular tearing and total nasal symptoms compared to vehicle-control at the second to last and final assessment time points. These data helped us to determine our path forward with EBI-005 as a potential new treatment option for patients with moderate to severe allergic conjunctivitis. We will be making comments on our allergic conjunctivitis development plan on today's call.
- Granted a U.S. patent for EBI-005 encompassing both composition-of-matter and methods of use claims, which expires in 2031.
- Advanced our EBI-031 (anti-IL-6) program toward an expected IND filing for the indication of diabetic macular edema (DME) by the end of 2015. EBI-031 is an antibody with the potential for a longer half-life compared with approved intravitreal protein therapeutics.
$20 millionin a private placement financing of Eleven Biotherapeutics common stock and warrants. Funding from the financing will be used to further advance Eleven's pipeline of protein therapeutics to treat diseases of the eye including EBI-005 for the treatment of moderate to severe dry eye disease and moderate to severe allergic conjunctivitis.
Appointed industry and academic leaders
Wendy L. Dixon, PhD, Jay S. Duker, MD and Barry Gertz, MD, PhD to our Board of Directors. Dr. Dixon is the former Chief Marketing Officer and President of Global Marketing for Bristol Myers Squibb. Dr. Dukeris professor and chair of Ophthalmology at Tufts University School of Medicine and director of the New England Eye Center. Dr. Gertzis a venture partner at Clarus Ventures, Chief Medical Advisor for Relay Pharmaceuticalsand former Senior Vice President of Global Clinical Developmentat Merck.
Fourth Quarter and Year-End 2014 Financial Results
Revenue: Revenue was
$0.4 millionfor the three months ended December 31, 2014, compared to $0.5 millionfor the same period in 2013. Revenue was $2.2 millionfor the twelve months ended December 31, 2014compared to $1.3 millionfor the same period in 2013.
R&D Expenses: Research and development expenses were
$5.3 millionfor the three months ended December 31, 2014compared to $3.2 millionfor the same period in 2013. This increase was primarily due to EBI-005 related development expenses. Research and development expenses were $26.7 millionfor the twelve months ended December 31, 2014compared to $13.8 millionfor the same period in 2013.
G&A Expenses: General and administrative expenses were
$2.2 millionfor the three months ended December 31, 2014, compared to $1.4 millionfor the same period in 2013. This increase was primarily due to increased operating costs related to operating as a public company since February 2014and increased stock-based compensation expense. General and administrative expenses were $8.5 millionfor the twelve months ended December 31, 2014compared to $4.0 millionfor the same period in 2013.
Net Loss: Net loss applicable to common stockholders was
$8.1 million, or $0.49per share, for the three months ended December 31, 2014, compared to net loss applicable to common stockholders of $6.2 million, or $4.29per share, for the same period in 2013. Net loss applicable to common stockholders was $34.7 million, or $2.37per share, for the twelve months ended December 31, 2014compared to $21.9 million, or $16.18per share, for the same period in 2013.
Cash and Cash Equivalents: Cash and cash equivalents were
$54.1 millionas of December 31, 2014. We believe that our cash and cash equivalents as of December 31, 2014will enable us to fund our operating expenses, debt service obligations and capital expenditure requirements into 2016.
Upcoming Events and Presentations:
American Society of Cataract and Refractive Surgery(ASCRS) annual symposium, in San Diego, April 17-21, 2015.
Association for Research in Vision and Ophthalmology(ARVO) annual meeting, in Denver, May 3-7, 2015.
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.
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-031 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 intravitreal 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.
Cautionary Note on 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 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.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Three Months Ended
Twelve Months Ended
|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||)|
|Cumulative preferred stock dividends||-||(1,142||)||(519||)||(3,857||)|
|Net loss applicable to common stockholders||$||(8,139||)||$||(6,208||)||$||(34,675||)||$||(21,882||)|
|Net loss per share applicable to common stockholders—basic and|
|Weighted-average number of common shares used in net loss per|
|share applicable to common stockholders—basic and diluted||16,692||1,447||14,644||1,352|
ELEVEN BIOTHRAPEUTICS, INC.
CONDENSED BALANCE SHEETS
|Cash and cash equivalents||$||54,059||$||7,942|
|Prepaid expenses and other current assets||342||88|
|Total current assets||54,401||8,030|
|Property and equipment, net||486||759|
|Liabilities, convertible preferred stock, and stockholders' equity (deficit)|
|Notes payable, current portion||251||1,642|
|Deferred revenue, current portion||506||1,115|
|Total current liabilities||5,202||5,353|
|Deferred revenue, net of current portion||-||355|
|Restricted stock liability||4||10|
|Notes payable, net of current portion||9,749||2,876|
|Series A convertible preferred stock||-||45,035|
|Series B convertible preferred stock||-||11,643|
|Stockholders' equity (deficit):|
|Additional paid-in capital||128,558||3,260|
|Total stockholders' equity (deficit)||36,826||(54,332||)|
|Total liabilities, convertible preferred stock and stockholders' equity (deficit)||$||55,000||$||11,237|
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