Eleven Biotherapeutics Reports Second Quarter 2017 Financial Results
-- AnnouncedData and Safety Monitoring Board Recommendation to Continue Phase 3 Registration Trial of Vicinium™ as Planned --
-- Entered Collaboration with
-- Management to Host Conference Call Today at
“The second quarter was a very productive one for Eleven Bio. We significantly advanced our clinical development program for our lead candidate Vicinium™. Our independent Data Safety Monitoring Board (DSMB) had previously only reviewed safety data from our Phase 3 registration trial, but in June they undertook their first review of preliminary efficacy in conjunction with safety data, and recommended that the trial continue without modification. Patients with Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) have limited therapeutic options and frequently require cystectomies to prevent disease progression. Bladder removal, however, is a serious and life-altering surgery associated with significant morbidity and mortality. We consider the results of the DSMB’s review to be a very significant step, as they suggest that Vicinium may offer patients a positive non-surgical benefit/risk profile versus the standard of care,” said Stephen Hurly, President and Chief Executive Officer of
“We were also very excited to announce that we entered into a collaboration with the
Second Quarter and Recent Business Highlights and Anticipated Upcoming Milestones:
Vicinium is based on Eleven’s TPT technology. TPTs are fully biologic, single protein molecules that selectively bind to cell surface markers that are over-expressed on cancer cells. The TPTs are then internalized by cancer cells, and once inside, release highly cytotoxic payloads to selectively kill the cell while sparing non-targeted healthy cells. TPTs are specifically designed to improve upon and overcome the challenges of existing antibody drug conjugates (ADCs) by directly killing cancer cells, promoting systemic anti-tumor immune responses and delivering better tumor penetration with an improved payload that is capable of killing both dividing and non-dividing cancer cells. TPTs are designed to be stable by using a single protein structure that Eleven believes will improve safety and tolerability.
Vicinium is a single protein TPT molecule composed of an antibody fragment genetically fused to a potent cytotoxic payload. Vicinium selectively binds to epithelial cell adhesion molecules (EpCAM), a cell surface marker that is highly expressed on many cancers, including high grade NMIBC, but is present at minimal to no levels on healthy bladder tissue. After binding to EpCAM on the surface of the tumor cell, Vicinium is internalized into the cell where its potent cytotoxic cell killing payload, Pseudomonas Exotoxin A (ETA), is released, disrupting protein synthesis and leading to cell death. Vicinium is currently in a Phase 3 registration trial for the treatment of high-grade NMIBC in subjects who have previously received a minimum of two courses of BCG and whose disease is now BCG-unresponsive.
- Complete enrollment for Phase 3 registration clinical trial expected in first quarter of 2018
- Topline three-month data from Phase 3 registration clinical trial expected mid-2018; topline 12-month data now expected in second quarter of 2019
Eleven’s pipeline includes additional locally delivered product candidates, as well as a systemic platform. Given Eleven’s enthusiasm for quickly driving the development of Vicinium forward, the Company is focusing its resources on the continued advancement of its Phase 3 registration trial at this time and temporarily holding the development of its earlier-stage product candidates, Proxinium and VB6-845d. The Company looks forward to moving these forward at the appropriate time.
- Proxinium is a single protein anti-EpCAM antibody fragment fused with ETA for the treatment of late-stage, EpCAM-expressing, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
- Proxinium has received Orphan Drug Designation from the
U.S. Food and Drug Administration( FDA) and the European Medicines Agency(EMA).
- In prior Phase 1 and 2 clinical trials, Proxinium demonstrated anti-tumor activity both injected as well as un-injected tumors.
- At the appropriate time, the Company plans to evaluate Proxinium in a Phase 1/2a clinical trial in combination with a checkpoint inhibitor.
- Proxinium has received Orphan Drug Designation from the
- VB6-845d is a systemically-administered TPT utilizing a proprietary, highly potent, de-immunized plant toxin, deBouganin, for the treatment of solid tumors.
- At the appropriate time, the Company plans to file an investigational new drug (IND) application for VB6-845d and initiate a Phase 1 trial.
May 2017, Eleven announced the appointment of David Brooks, M.D., Ph.D., as Senior Vice President, Clinical Development. Dr. Brooks is responsible for the execution of Eleven’s ongoing and planned clinical trials.
Second Quarter 2017 Financial Results:
- Cash Position: Cash and cash equivalents were
$15.8 millionas of June 30, 2017, compared to $25.3 millionas of December 31, 2016.
- Revenue: Eleven did not record any revenue for the three months ended
June 30, 2017, compared to revenue of $0.3 millionfor the same period in 2016. This decrease was due to the termination of Eleven’s collaboration agreement with Thrombogenics N.V.in June 2016.
- R&D Expenses: Research and development expenses were
$2.9 millionfor the three months ended June 30, 2017, compared to $3.3 millionfor the same period in 2016. This decrease was primarily due to a reduction in EBI-031 development expenses. Effective August 2016, F. Hoffmann-La Roche Ltdand Hoffmann-La Roche Inc.( Roche) is responsible for developing EBI-031 pursuant to Eleven’s license agreement with Roche. This decrease was partially offset by increases in Vicinium-related development expenses, which began in September 2016.
- G&A Expenses: General and administrative expenses were
$2.2 millionfor the three months ended June 30, 2017, compared to $3.5 millionfor the same period in 2016. This decrease was primarily due to a reduction in professional fees.
- Net Loss: Net loss applicable to common stockholders was
$7.3 million, or $0.30per share, for the three months ended June 30, 2017, compared to net loss applicable to common stockholders of $6.5 million, or $0.33per 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:
David Brooks, MD, PhD, SVP, Clinical Development. “Development of Vicinium, an Intravesical Anti-EpCAM Toxin Fusion Protein, in Phase 3 for Non-Muscle Invasive Bladder Cancer.” 18th Future Directions in Urology Symposium (FDUS 18), August 20-23, 2017in Colorado Springs, Colorado. Gregory P. Adams, PhD, CSO. Keynote Presentation: “Enabling Effective Immuno-Oncology.” CHI’s 5th Annual Immunomodulatory Therapeutic Antibodies for Cancer, August 28-29, 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 (License Agreement) with
|ELEVEN BIOTHERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||2,909||3,298||5,783||7,930|
|General and administrative||2,241||3,471||4,454||5,618|
|(Gain) loss from change in fair value of contingent consideration||2,200||-||3,700||-|
|Total operating expenses||7,350||6,769||13,937||13,548|
|Loss from operations||(7,350||)||(6,492||)||(13,512||)||(13,042||)|
|Other income (expense), net||34||1||135||(1,023||)|
|Net loss per share —basic and diluted||$||(0.30||)||$||(0.33||)||$||(0.54||)||$||(0.71||)|
|Weighted-average number of common shares used in net loss|
|per share —basic and diluted||24,685||19,874||24,648||19,756|
|ELEVEN BIOTHERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$||15,751||$||25,342|
|Prepaid expenses and other current assets||707||585|
|Total current assets||16,458||25,927|
|Property and equipment, net||632||796|
|Liabilities and stockholders' equity|
|Due to related party||118||114|
|Total current liabilities||3,855||3,980|
|Deferred tax liability||16,335||16,335|
|Additional paid-in capital||162,564||161,963|
|Total stockholders' equity||25,910||38,677|
|Total liabilities and stockholders' equity||$||95,048||$||104,097|
Stern Investor Relations, Inc.
Hannah Deresiewicz, 212-362-1200