Eleven Biotherapeutics Reports Fourth Quarter and Full-Year 2017 Operating Results and Vicinium Development
Progress
Preliminary Data from Phase 3 VISTA Trial in Bladder Cancer to be Presented During Plenary Session at
American Urological Association Annual Meeting; Company to Host Conference Call in Conjunction with Data Presentation in May
2018
Expected Operating Runway Extended into the First Quarter of 2019
Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate
(ADC) therapies for the treatment of cancer, today reported key pipeline progress and operating results for the quarter and year
ended December 31, 2017.
“2017 was a year of significant developments for our company, and as we look ahead, I am highly encouraged by what we have
already achieved in 2018. Vicinium™, our lead product candidate, holds significant potential in treating a range of cancers, and is
well underway in a registration trial for people with non-muscle invasive bladder cancer,” said Stephen Hurly, president and chief
executive officer of Eleven Biotherapeutics. “We recently completed enrollment in our Phase 3 VISTA trial, and we are pleased that
initial data from the first patients in the VISTA trial were selected for an oral presentation at the American Urological
Association Annual Meeting. 2018 is set to be a transformative year, and with the completion of our recent equity financing, we are
capitalized to continue advancing Vicinium. We look forward to assessing its efficacy and safety in NMIBC, and exploring
opportunities to expand its utility in other indications and in combination regimens.”
Recent Pipeline and Corporate Highlights
- On March 23, 2018, Eleven Biotherapeutics closed a $10.0 million equity financing priced
at-the-market. This financing, coupled with the proceeds from the company’s $8.0 million public offering completed in November
2017, extends the company’s cash runway into the first quarter of 2019 based on its current operating plan.
- In March 2018, Eleven Biotherapeutics announced that enrollment was completed in the company’s Phase
3 VISTA trial evaluating its lead product candidate, Vicinium, for the treatment of patients with non-muscle invasive bladder
cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG).
- In December 2017, a trial at the US National Cancer Institute (NCI) of Vicinium in combination with
AstraZeneca's immune checkpoint inhibitor, Imfinzi® (durvalumab), for the treatment of NMIBC opened.
- In September 2017, Eleven Biotherapeutics completed the manufacturing of all Vicinium necessary for
its ongoing trials.
Upcoming Data Presentations
-
Present Preclinical Data at AACR: Eleven Biotherapeutics will present preclinical data from its deBouganin program at
the 2018 American Association for Cancer Research (AACR) Annual Meeting during two poster sessions. The company’s systemically
administered product candidates are designed using its proprietary de-immunized variant of the plant-derived cytotoxin
bouganin, deBouganin. Details of the presentations are as following:
-
Poster Title: VB6-845d Tumor Cell Killing Elicits Biologic Features of Immunogenic Cell Death
- Date and Time: April 16, 2018 from 1:00 to 5:00 p.m. CT
-
Poster Title: Engineering and Characterization of Anti-PSMA Humabody-DeBouganin Fusion Proteins
- Date and Time: April 18, 2018 from 8:00 a.m. to 12:00 p.m. CT
-
Present Data from Phase 3 VISTA Trial at AUA Annual Meeting: Eleven Biotherapeutics will present the first, topline data
from its Phase 3 VISTA trial of Vicinium in patients with NMIBC who have been previously treated with BCG during a plenary
session at this year’s American Urological Association Annual Meeting being held in San Francisco. The data being presented are
three-month data from an initial 75 patients in the trial. Details of the presentation are as follows:
-
Presentation Title: Phase 3 Study of Vicinium in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Initial
Results
- Date and Time: Monday, May 21, 2018 at 11:00 a.m. PT
Fourth Quarter and Full-Year 2017 Financial Results
- Cash Position: Cash and cash equivalents were $14.7 million as of December 31, 2017, compared
to $25.3 million as of December 31, 2016, a decrease of $10.6 million, which was primarily driven by $17.6 million in cash used
by operating activities plus, $0.1 million in capital expenditures, partially offset by $7.1 million in cash provided through the
November 2017 underwritten public offering.
- Revenue: No revenue was recognized during the three months ended December 31, 2017, compared
to $0.8 million for the same three-month period in 2016. Revenue was $0.4 million for the twelve months ended December 31, 2017,
compared to $30.0 million for the same period in 2016. The decrease was primarily due to a decrease in license revenue as we
recognized the upfront license fee and development milestone payment under the license agreement with Roche, relating to the
execution of the license agreement and the successful submission of the IND application for EBI-031 during 2016, as well as a
decrease in collaboration revenue from a terminated collaboration.
- R&D Expenses: Research and development expenses were $3.1 million for the three months
ended December 31, 2017, compared to $2.8 million for the same period in 2016. For the twelve months ended December 31, 2017
research and development expenses were $12.5 million compared to $13.5 million for the 2016 fiscal year. The decrease of $1.0
million was primarily due to a decrease in EBI-031 related development expenses of $3.0 million due to the license agreement with
Roche in which Roche is responsible for all on-going development expenses, as well as a decrease of $1.7 million of
isunakinra-related development expenses, which development activities are no longer ongoing. These decreases were partially
offset by increases in Vicinium-related development expenses of $5.4 million, since the company’s acquisition of Viventia Bio
Inc. (Viventia) in September 2016.
- G&A Expenses: General and administrative expenses were $2.0 million for the three months
ended December 31, 2017, compared to $2.8 million for the same period in 2016. For the twelve months ended December 31, 2017
general and administrative expenses were $8.1 million compared to $14.7 million for fiscal 2016. The decrease of $6.7 million was
primarily due to a reduction of professional fees as well as salaries and related costs for personnel, including stock-based
compensation. For the year ended December 31, 2016, the company had higher professional fees related to the license agreement
with Roche, the company’s 2016 review of strategic alternatives and the acquisition of Viventia. In addition, for the year ended
December 31, 2016, the company recorded higher severance costs related to the acquisition of Viventia.
- Net Income (Loss): Net loss was $6.6 million, or $0.22 per share, for the three months ended
December 31, 2017, compared to net loss of $3.5 million, or $0.15 per share, for the same period in 2016. Net loss was $29.0
million, or $1.11 per share, for the twelve months ended December 31, 2017, compared to net income of $1.9 million, or $0.09 per
share, for the same period in 2016. Fiscal 2016 was benefited by approximately $30.0 million in revenue under the company’s
license agreement with Roche while no comparable revenue was recognized during fiscal 2017.
- Financial Guidance: Following Eleven Biotherapeutics’ recent $10.0 million equity financing in
March 2018, the company expects to have capital to fund its current operating plans into the first quarter of 2019; however, we
have based this estimate on assumptions that may prove to be wrong, and our capital resources may be utilized faster than we
currently expect.
About Vicinium™
Vicinium™, Eleven Biotherapeutics’ lead product candidate, is a next-generation antibody-drug conjugate (ADC) developed using
the company’s proprietary Targeted Protein Therapeutics platform. Vicinium is comprised of a recombinant fusion protein that
targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload,
Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the
payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy
tissues, thereby improving its safety. In prior clinical studies conducted by Eleven Biotherapeutics, EpCAM has been shown to be
overexpressed in non-muscle invasive bladder cancer (NMIBC) cells with minimal to no EpCAM expression observed on normal bladder
cells. Eleven Biotherapeutics is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for
the treatment of NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is
now BCG-unresponsive. Topline, three-month data from the trial are expected in mid-2018. Additionally, Eleven Biotherapeutics
believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well
with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being
explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a late-stage clinical company advancing next-generation antibody-drug conjugate (ADC) therapies
for the treatment of cancer based on the company’s Targeted Protein Therapeutics platform. The company’s lead program, Vicinium™,
is currently in a Phase 3 registration trial for the treatment of non-muscle invasive bladder cancer, with topline data expected in
mid-2018. Vicinium incorporates a tumor-targeting antibody fragment and a protein cytotoxic payload into a single protein molecule
designed to selectively and effectively kill cancer cells while sparing healthy cells. For more information, please visit the
company’s website at www.elevenbio.com.
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 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 additional capital to continue to fund operations 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 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.
|
ELEVEN BIOTHERAPEUTICS, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(in thousands, except per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
|
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
- |
|
|
$ |
825 |
|
|
$ |
425 |
|
|
$ |
29,981 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,108 |
|
|
|
2,795 |
|
|
|
12,510 |
|
|
|
13,479 |
|
|
General and administrative |
|
|
1,985 |
|
|
|
2,752 |
|
|
|
8,070 |
|
|
|
14,736 |
|
|
Loss (gain) from change in fair value of contingent
consideration |
|
|
1,500 |
|
|
|
(1,100 |
) |
|
|
9,100 |
|
|
|
(1,100 |
) |
|
|
|
|
|
|
Total operating expenses |
|
|
6,593 |
|
|
|
4,447 |
|
|
|
29,680 |
|
|
|
27,115 |
|
Loss (gain) from operations |
|
|
(6,593 |
) |
|
|
(3,622 |
) |
|
|
(29,255 |
) |
|
|
2,866 |
|
Other income (expense), net |
|
|
46 |
|
|
|
96 |
|
|
|
226 |
|
|
|
(970 |
) |
Net (loss) income before income taxes |
|
|
(6,547 |
) |
|
|
(3,526 |
) |
|
|
(29,029 |
) |
|
|
1,896 |
|
|
Provision for income taxes |
|
|
- |
|
|
|
5 |
|
|
|
- |
|
|
|
5 |
|
Net (loss) income and comprehensive (loss) income |
|
$ |
(6,547 |
) |
|
$ |
(3,531 |
) |
|
$ |
(29,029 |
) |
|
$ |
1,891 |
|
Net (loss) income per share —basic |
|
$ |
(0.22 |
) |
|
$ |
(0.15 |
) |
|
$ |
(1.11 |
) |
|
$ |
0.09 |
|
Weighted-average number of common shares used in net (loss) income per share —basic
|
|
|
30,385 |
|
|
|
24,296 |
|
|
|
26,105 |
|
|
|
21,083 |
|
Net (loss) income per share —diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.15 |
) |
|
$ |
(1.11 |
) |
|
$ |
0.09 |
|
Weighted-average number of common shares used in net (loss) income per share —diluted
|
|
|
30,385 |
|
|
|
24,296 |
|
|
|
26,105 |
|
|
|
21,733 |
|
|
|
|
|
|
|
|
|
|
|
ELEVEN BIOTHERAPEUTICS, INC. |
CONSOLIDATED BALANCE SHEETS |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,680 |
|
|
$ |
25,342 |
|
|
Prepaid expenses and other current assets |
|
|
301 |
|
|
|
585 |
|
|
|
|
|
|
Total current assets |
|
|
14,981 |
|
|
|
25,927 |
|
Property and equipment, net |
|
|
522 |
|
|
|
796 |
|
Restricted cash |
|
|
10 |
|
|
|
10 |
|
Intangible assets |
|
|
46,400 |
|
|
|
60,500 |
|
Goodwill |
|
|
13,064 |
|
|
|
16,864 |
|
Other assets |
|
|
120 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
75,097 |
|
|
$ |
104,097 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
907 |
|
|
$ |
1,667 |
|
|
Accrued expenses |
|
|
3,813 |
|
|
|
1,774 |
|
|
Deferred revenue |
|
|
- |
|
|
|
425 |
|
|
Due to related party |
|
|
- |
|
|
|
114 |
|
|
|
|
|
|
Total current liabilities |
|
|
4,720 |
|
|
|
3,980 |
|
Other liabilities |
|
|
215 |
|
|
|
- |
|
Warrant liability |
|
|
- |
|
|
|
5 |
|
Deferred tax liability |
|
|
12,528 |
|
|
|
16,335 |
|
Contingent consideration |
|
|
39,600 |
|
|
|
45,100 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
Common stock |
|
|
35 |
|
|
|
25 |
|
|
Additional paid-in capital |
|
|
170,330 |
|
|
|
161,963 |
|
|
Accumulated deficit |
|
|
(152,331 |
) |
|
|
(123,311 |
) |
Total stockholders' equity |
|
|
18,034 |
|
|
|
38,677 |
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
75,097 |
|
|
$ |
104,097 |
|
THRUST
Monique Allaire, 617-895-9511
monique@thrustir.com
or
Alicia Davis, 910-620-3302
alicia@thrustir.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20180404006207/en/