Eleven Biotherapeutics Reports First Quarter 2017 Financial Results
-- Continued Advancing Ongoing Phase 3 Registration Clinical Trial of Vicinium™ in Non-Muscle Invasive Bladder Cancer -
-- Presented Preclinical Data at AACR Suggesting that Lead Compounds Induce Anti-Tumor Immune Response That Can Potentiate the Activity of Immuno-Oncology Agents --
-- Expanded Clinical Development Team to Support Ongoing and Planned Trials --
-- Management to Host Conference Call Today at
"During our first quarter of 2017, we made meaningful progress,
advancing our Phase 3 registration clinical trial of Vicinium and
continuing development efforts with Proxinium™ and VB6-845d," said
Stephen Hurly, President and Chief Executive Officer of
First Quarter and Recent Business Highlights and Anticipated Upcoming Milestones:
Vicinium: Vicinium is a single protein anti-epithelial cell adhesion molecule (anti-EpCAM) antibody fragment fused with Pseudomonas Exotoxin A (ETA) that is designed to specifically target and deliver a potent anti-cancer payload directly into tumor cells. Vicinium is currently in a Phase 3 registration clinical trial for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) in subjects who have previously received two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive.
- Complete enrollment for Phase 3 registration clinical trial expected in second half of 2017
- Topline data from Phase 3 registration clinical trial expected in 2018
Proxinium: Proxinium is a single protein anti-EpCAM antibody
fragment fused with ETA for the treatment of late-stage squamous cell
carcinoma of the head and neck (SCCHN). Proxinium has received Orphan
Drug Designation from the
- Initiation of Phase 1/2a clinical trial evaluating Proxinium in combination with a checkpoint inhibitor expected in second half of 2017
As part of the same poster presentation, Eleven shared data from a preclinical model in patient-derived xenograft tumor-bearing mice reconstituted with a human immune system, which was used to assess the combination of intratumoral injection of VB4-845 with the anti-PD1 antibody, nivolumab. Treatment with VB4-845 alone suppressed the growth of injected tumors, while monotherapy nivolumab had little effect. In contralateral, non-injected tumors, responses from mice treated with both VB4-845 and nivolumab were more pronounced than responses in mice treated with either product as a monotherapy. Based on these results, Eleven believes that VB4-845 killing of tumor cells could facilitate and augment checkpoint inhibitor anti-tumor activity.
Systemically-administered TPT Pipeline: Eleven's initial systemically-administered TPTs leverage a proprietary, highly potent, de-immunized, plant toxin, deBouganin. DeBouganin has picomolar killing of cancer cells and may be effective against cancer stem cells. In preclinical studies, deBouganin demonstrated the ability to avoid multi-drug resistance mechanisms that can decrease the efficacy of small molecule payloads. Based on these results, Eleven believes that deBouganin-based therapies may be effective against a wide spectrum of cancers.
- Investigational New Drug Application (IND) submission for VB6-845d planned for first quarter of 2018
At the AACR Annual Meeting, Eleven presented preclinical data suggesting that its deBouganin payload is capable of effectively killing tumor cells that are resistant to treatment with antibody drug conjugates (ADCs) composed of DM-1 and MMAE payloads when conjugated to the same monoclonal antibody, trastuzumab. The Company believes this is due, in part, to deBouganin's lack of sensitivity to both the multidrug resistance pumps and the changes in phosphorylation status of proteins involved in cell proliferation and survival that allow some cancers to escape the action of anti-mitotic ADCs.
Corporate: Eleven further expanded its internal clinical
development team with two key hires:
First Quarter 2017 Financial Results:
Cash Position: Cash and cash equivalents were
$20.3 millionas of March 31, 2017, compared to $25.3 millionas of December 31, 2016.
Revenue: Revenue was
$0.4 millionfor the three months ended March 31, 2017, compared to $0.2 millionfor the same period in 2016. This increase was due to revenue recognized from the License Agreement (License Agreement) with F. Hoffmann-La Roche Ltdand Hoffmann-La Roche Inc.(Roche).
R&D Expenses: Research and development expenses were
$2.9 millionfor the three months ended March 31, 2017, compared to $4.6 millionfor the same period in 2016. The decrease was due primarily to a reduction in isunakinra and EBI-031 related development expenses, partially offset by an increase in Vicinium related development expenses.
G&A Expenses: General and administrative expenses were
$2.2 millionfor the three months ended March 31, 2017, compared to $2.1 millionfor the same period in 2016.
Net Loss: Net loss was
$6.1 million, or $0.25per share, for the three months ended March 31, 2017, compared to net loss of $7.6 million, or $0.39per share, for the same period in 2016.
- Financial Guidance: Based on current operating plans, Eleven expects to have cash to fund research and development programs and operations into early 2018.
Upcoming Events and Presentations:
American Urological Association2017 Annual Meeting, May 12-16, 2017in Boston, Massachusetts
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.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, the Company's strategy, future
operations, 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 occurrence of any event change or
other circumstances that could give rise to the termination of the
License Agreement, the uncertainties inherent in receiving future
payments pursuant to the License Agreement, the uncertainties inherent
in the initiation and conduct of clinical trials, our ability to
successfully develop our product candidates and complete our planned
clinical programs, our ability to obtain marketing approvals for our
product candidates, expectations regarding our ongoing clinical trials,
availability and timing of data from clinical trials, whether interim
results from a clinical trial will be predictive of the final results of
the trial or results of early clinical studies will be indicative of the
results of future studies, the adequacy of any clinical models,
expectations regarding regulatory approvals, our ability to obtain,
maintain and protect our intellectual property for our technology and
products, availability of funding sufficient for the Company's
foreseeable and unforeseeable operating expenses and capital expenditure
requirements, other matters that could affect the financial performance
of the Company, other matters that could affect the availability or
commercial potential of the Company's product candidates and other
factors discussed in the "Risk Factors" section of the Company's Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports
filed with the
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
Three Months Ended
|Research and development||2,874||4,632|
|General and administrative||2,213||2,147|
|Loss from change in fair value of contingent consideration||1,500||-|
|Total operating expenses||6,587||6,779|
|Loss from operations||(6,162||)||(6,550||)|
|Other income (expense), net||101||(1,024||)|
|Net loss per share —basic and diluted||$||(0.25||)||$||(0.39||)|
|Weighted-average number of common shares used in net loss|
|per share —basic and diluted||24,610||19,639|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||20,268||$||25,342|
|Prepaid expenses and other current assets||712||585|
|Total current assets||20,980||25,927|
|Property and equipment, net||714||796|
Liabilities and stockholders' equity
|Due to related party||115||114|
|Total current liabilities||3,226||3,980|
|Deferred tax liability||16,335||16,335|
|Additional paid-in capital||162,243||161,963|
|Total stockholders' equity||32,905||38,677|
|Total liabilities and stockholders' equity||$||99,068||$||104,097|
Stern Investor Relations
News Provided by Acquire Media