Eleven Biotherapeutics Reports Fiscal First Quarter 2014 Financial Results
- Enrollment Complete in EBI-005 Phase 2 Allergic Conjunctivitis Study -
Management to host conference call today at
"Earlier this year, we completed our initial public offering, improving our balance sheet and attracting a number of new shareholders, and strengthened our leadership team with the appointments of ophthalmology industry veterans to our board and management team. We were also pleased by the interest of the medical and scientific community in the data we presented at a number of ophthalmology industry conferences this spring, including clinical data on EBI-005, the first IL-1 (Interleukin-1) signaling inhibitor designed for topical ocular administration, and preclinical data on EBI-029, an IL-6 (Interleukin-6) inhibitor optimized for localized ocular administration in diabetic macular edema."
First Quarter 2014 and Recent Business Highlights:
- Initiated a pivotal Phase 3 clinical study with EBI-005 in dry eye disease with top-line results expected in early 2015.
- Initiated and completed patient enrollment in a Phase 2 clinical trial of EBI-005 for the treatment of allergic conjunctivitis with top-line results expected in the fourth quarter of 2014.
Presented at a number of ophthalmology industry conferences including:
Association for Research in Vision and Ophthalmology(ARVO) 2014 Annual Meeting, at which Eleven Biotherapeuticsresearchers gave three poster presentations elaborating on Eleven's understanding of cytokine biology to target the treatment of front and back of eye diseases. These posters included clinical data on EBI-005 demonstrating improvements in signs and symptoms in patients with dry eye disease through IL-1 Inhibition, and preclinical data on EBI-029 demonstrating inhibition of IL-6 as a validated target for treating diabetic macular edema.
2014 American Society of Cataract and Refractive Surgery
(ASCRS) Annual Symposium, at which Michael H.
Goldstein, M.D., M.B.A.,
Eleven Biotherapeutics'Vice President of Clinical Research and co-director of the Cornea, External Disease and Cataract Service group at Tufts University/ New England Eye Center, presented Phase 1b/2a clinical data on Eleven's lead product candidate EBI-005 for the treatment of dry eye disease. Dr. Goldstein received the honor of a ‘Best Paper in Session' award and was listed in Eye World Today and the ASCRS meeting newspaper.
2014 Ophthalmology Innovation Summit (OIS) @
American Society of Cataract and Refractive Surgery(ASCRS) Annual Meeting, at which Abbie Celnikerparticipated in a session, along with other industry leaders, on the topic of dry eye disease. The participants in the session, who represented a cross section of industry and scientific thought leaders, discussed the role dry eye technologies and therapies play in ophthalmic practice.
World Ophthalmology Congress(WOC) 2014, at which Michael Goldstein, M.D., presented on the topic of IL-1 inhibition for dry eye disease and highlighted EBI-005 clinical data as a case study.
10th Annual Protein and Engineering
Summit (PEGS), at which
Eleven Biotherapeuticsresearchers presented data demonstrating the power of Eleven's AMP-Rx platform to design and engineer novel protein therapeutics. Eleven's presentation topics included modulating cytokines to treat front and back of eye disease such as IL-1 inhibition with EBI-005, IL-6 inhibition with EBI-029 and IL-17 inhibition with EBI-028 and designing topical treatments of ocular surface inflammatory disorders, such as EBI-005, to have low immunogenicity potential.
Completed our initial public offering, with aggregate net proceeds of
$50.2 million, net of underwriting discounts and commissions and other offering expenses payable by us.
Strengthened our leadership team with the appointment of ophthalmic
industry veterans, including
Paul Chaneyas a member of our Board of Directors and Gary Sternberg, M.D., M.B.A., as Executive Vice President Corporate and Business Development.
Added to the Russell Indexes on
March 31, 2014, including the Russell 2000 and Russell 3000 index.
Upcoming Events and Presentations:
Lens Association of Ophthalmologists(CLAO), June 14, 2014
International Society of Ophthalmologists(ISOPT), June 19-22, 2014
Total operating expenses for the quarter ended
Net cash used in operating activities during the quarter ended
Net loss applicable to common stockholders was
Conference Call Information:
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,
which was designed, engineered and generated using the Company's AMP-Rx
platform and is being developed as a topical treatment for dry eye
disease and allergic conjunctivitis. In 2013,
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, 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
annual report on Form 10-K filed with the
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
Three Months Ended
|Research and development||5,819||4,496|
|General and administrative||1,938||939|
|Total operating expenses||7,757||5,435|
|Loss from operations||(7,189||)||(5,435||)|
|Other income (expense):|
|Other (expense) income, net||51||2|
|Total other expense, net||(33||)||(77||)|
|Net loss and comprehensive loss||$||(7,222||)||$||(5,512||)|
|Cumulative preferred stock dividends||(519||)||(893||)|
|Net loss applicable to common stockholders||$||(7,741||)||$||(6,405||)|
|Net loss per share applicable to common stockholders—basic and diluted||$||(0.80||)||$||(5.14||)|
|Weighted-average number of common shares used in net loss per share applicable to common stockholders—basic and diluted||9,635||1,247|
ELEVEN BIOTHRAPEUTICS, INC.
|Cash and cash equivalents||$||53,964||$||7,942|
|Prepaid expenses and other current assets||443||88|
|Total current assets||54,407||8,030|
|Property and equipment, net||708||759|
|Liabilities, convertible preferred stock, and stockholders' equity (deficit)|
|Notes payable, current portion||1,642||1,642|
|Deferred revenue, current portion||1,134||1,115|
|Total current liabilities||6,303||5,353|
|Deferred revenue, net of current portion||223||355|
|Restricted stock liability||8||10|
|Notes payable, net of current portion||2,466||2,876|
|Series A convertible preferred stock||-||45,035|
|Series B convertible preferred stock||-||11,643|
|Stockholders' equity (deficit):|
|Additional paid-in capital||111,027||3,260|
|Total stockholders' equity (deficit)||46,227||(54,332||)|
|Total liabilities, convertible preferred stock and stockholders' equity (deficit)||$||55,227||$||11,237|
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