Eleven Biotherapeutics Reports Second Quarter 2015 Financial Results
Management to host conference call today at
"We are continuing to focus on advancing our ocular therapeutics
pipeline. We recently initiated a pivotal Phase 3 study of EBI-005 in
moderate to severe allergic conjunctivitis patients suffering from the
late-phase inflammatory response and are now planning to advance
development of EBI-031 for the treatment of diabetic macular edema and
uveitis with an IND filing expected in the first half of 2016. Our
development plans are supported by data presented recently on both
EBI-005 and EBI-031 at the ARVO 2015 Annual Meeting," said
Second Quarter and Recent Business Highlights:
- Initiated a Phase 3 study of EBI-005 for the treatment of moderate to severe allergic conjunctivitis patients suffering from the late-phase inflammatory response. EBI-005 offers the potential to mediate this late-phase allergic response by blocking the interleukin-1 (IL-1) receptor, believed to play a key role in ocular surface disease, while also exhibiting an acceptable safety and tolerability profile to date. Top-line data from this study is expected in the first quarter of 2016. The initiation of this Phase 3 study follows completion of a Phase 2 clinical trial in which EBI-005 achieved statistically significant improvements in ocular itching, ocular tearing and nasal symptoms in the late phase allergen response in moderate to severe allergic conjunctivitis patients following allergen exposure in a modified direct conjunctival allergen challenge (CAPT) model.
- Presented clinical data for EBI-005 for the treatment of allergic conjunctivitis at the Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting. EBI-005 showed clinically relevant, statistically significant improvements in multiple endpoints including ocular itching, ocular tearing and nasal symptoms associated with the late phase allergen response. These data further support the important role of IL-1 as a key target for ocular surface inflammation associated with allergic conjunctivitis, a mechanistically different disease from dry eye disease due to its single, central mechanism of allergen stimulation as opposed to the many diverse causes of ocular surface inflammation in dry eye disease.
- Presented preclinical data for EBI-031 for the treatment of diabetic macular edema (DME) at the ARVO 2015 Annual Meeting. Preclinical data exhibit the potential ability of EBI-031 to potently inhibit interleukin-6 (IL-6) signaling with extended vitreal retention compared to existing therapies. Based on these data, which we believe support our design criteria necessary for an intravitreal IL-6 antagonist, Eleven plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2016 for the clinical development of EBI-031 in DME and uveitis.
- Presented at the 12th Annual International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) on ocular surface inflammation and the use of EBI-005 in patients with allergic conjunctivitis and dry eye disease.
- Reported top-line results from the OASIS study, a pivotal Phase 3 study of EBI-005, in moderate to severe dry eye disease. The co-primary endpoints of the Phase 3 study were the total corneal fluorescein staining score and the patient-reported measurement related to ocular pain and discomfort based on the ocular surface disease index (OSDI), comparing the mean change from baseline at week 12 for treatment with EBI-005 to treatment with vehicle control. In this study, EBI-005 did not meet either of these two co-primary endpoints. Eleven does not plan to pursue further development of EBI-005 for dry eye disease. Eleven is focusing on developing EBI-005 to meet unmet medical needs in allergic conjunctivitis, based on our previously-reported Phase 2 data and scientific rationale supporting EBI-005 as a treatment for allergic conjunctivitis.
Second Quarter 2015 Financial Results:
Revenue: Revenue was
$0.1 millionfor the three months ended June 30, 2015, compared to $0.8 millionfor the same period in 2014.
R&D Expenses: Research and development expenses were
$6.3 millionfor the three months ended June 30, 2015, compared to $6.8 millionfor the same period in 2014. This decrease was primarily due to lower EBI-005 related development expenses partially offset by increases in EBI-031 related development expenses.
G&A Expenses: General and administrative expenses were
$2.2 millionfor the three months ended June 30, 2015, compared to $2.1 millionfor the same period in 2014.
Net Loss: Net loss applicable to common stockholders was
$6.9 million, or $0.36per share, for the three months ended June 30, 2015, compared to net loss applicable to common stockholders of $8.1 million, or $0.51per share, for the same period in 2014.
Cash and Cash Equivalents: Cash and cash equivalents were
$53.5 millionas of June 30, 2015. We believe that our cash and cash equivalents as of June 30, 2015will enable us to fund our operating expenses and debt service obligations into the second half of 2016.
Upcoming Events and Presentations:
NewsMakers in the Biotech Industry,
September 10, 2015at 3:30 p.m. ETin New York.
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 preclinical product candidate is
EBI-031 for treatment of diabetic macular edema, or DME and uveitis.
EBI-031 has been designed and engineered 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 demonstrated
a longer vitreal retention time in preclinical models than antibodies
and antibody like molecules approved for intravitreal injection. We are
undertaking the necessary manufacturing development work and nonclinical
safety studies to support the submission of an investigational new drug
application, or IND, to the
About Eleven Biotherapeutics
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
most recently filed with the Securities and Exchange Commission and
other reports on file with the
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
Three Months Ended
Six Months Ended
|Research and development||6,269||6,754||11,507||12,573|
|General and administrative||2,247||2,052||4,850||3,990|
|Total operating expenses||8,516||8,806||16,357||16,563|
|Loss from operations||(8,402||)||(8,045||)||(15,999||)||(15,234||)|
|Other income (expense), net||1,496||(76||)||2,569||(109||)|
|Cumulative preferred stock dividends||-||-||-||(519||)|
|Net loss applicable to common stockholders||$||(6,906||)||$||(8,121||)||$||(13,430||)||$||(15,862||)|
|Net loss per share applicable to common stockholders—basic and|
|Weighted-average number of common shares used in net loss per|
|share applicable to common stockholders—basic and diluted||19,087||16,055||18,532||12,863|
|ELEVEN BIOTHRAPEUTICS, INC.|
|CONDENSED BALANCE SHEETS|
|Cash and cash equivalents||$||53,494||$||54,059|
|Prepaid expenses and other current assets||938||342|
|Total current assets||54,432||54,401|
|Property and equipment, net||580||486|
|Liabilities and stockholders' equity|
|Notes payable, current portion||2,523||251|
|Total current liabilities||5,472||5,202|
|Notes payable, net of current portion||12,171||9,749|
|Additional paid-in capital||142,380||128,558|
|Total stockholders' equity||37,219||36,826|
|Total liabilities and stockholders' equity||$||55,122||$||55,000|
News Provided by Acquire Media