-Management to host conference call today at
8:30 a.m. ET-
Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage
clinical oncology company advancing a broad pipeline of novel
product candidates based on its Targeting Protein Therapeutics
(TPTs) platform, today reported financial results for the third
quarter ended September 30, 2016, and recent business
highlights.
"This is an exciting period for Eleven. We completed the Roche
licensing deal, including $30 million in upfront and milestone
payments received to date. We also completed the acquisition of
Viventia Bio Inc. which allowed us to become a late-stage oncology
company. Perhaps most excitingly, we are making significant
progress in moving forward what we believe could be therapeutics
that materially improve patients’ lives. We anticipate complete
enrollment in the first half of next year for our Phase 3 clinical
trial of Vicinium™ as a potential treatment for high-grade
non-muscle invasive bladder cancer, and expect topline data in the
first half of 2018," said Stephen Hurly, President and Chief
Executive Officer of Eleven Biotherapeutics. "We also plan to
initiate our Phase 2 trial in late-stage squamous cell carcinoma of
the head and neck with Proxinium in combination with a checkpoint
inhibitor in the first half of 2017. Also in 2017, we plan on
submitting an IND with the FDA for our lead product in our systemic
pipeline based on our proprietary payload deBouganin. With the
combined expertise of Eleven and the Viventia team, I am very
excited about the opportunities we have ahead."
Third Quarter and Recent Business Highlights:
- Completed acquisition of Viventia Bio
Inc., creating a company focused on the development of novel
therapies based upon antibody fragments genetically fused to
cytotoxic proteins, or TPTs, as new treatments in areas of
oncology. Eleven’s pipeline now includes Viventia’s lead product
candidates Vicinium and Proxinium. Both product candidates are
anti-EpCAM (epithelial cell adhesion molecule) fusion proteins that
have been optimized for local tumor administration.
- Vicinium is in a Phase 3 clinical trial
for high grade non-muscle invasive bladder cancer (NMIBC) with
topline data expected in the first half of 2018. In a Phase 2
clinical trial, Vicinium demonstrated a complete response rate of
40% at three months with no patients discontinuing treatment due to
treatment related serious adverse events. To date, Vicinium has
been evaluated in more than 100 patients in previously completed
clinical trials.
- Proxinium is expected to enter a Phase
2 clinical trial in combination with a checkpoint inhibitor in the
first half of 2017 for the treatment of late-stage squamous cell
carcinoma of the head and neck. In previous clinical trials,
Proxinium was generally well-tolerated and showed signs of
anti-tumor activity. Proxinium has received orphan drug designation
from the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA), and Fast Track designation from the
FDA.
- Completed exclusive License Agreement
with Roche for IL-6 antagonist antibody technology, including
EBI-031. Eleven granted Roche an exclusive, worldwide license to
develop and commercialize EBI-031 and all other IL-6 antagonist
antibody technology owned by Eleven. Eleven has received $30
million in payments from Roche, including a $7.5 million upfront
payment in connection with the effectiveness of the License
agreement, and a $22.5 million milestone payment based on the IND
application for EBI-031 becoming effective. Under the terms of the
License Agreement, Eleven could receive up to an additional $240
million upon the achievement of certain future regulatory,
development and commercialization milestones. In addition, Eleven
is entitled to receive royalties based on net sales of potential
future products containing EBI-031 or any other potential future
products containing other Eleven IL-6 compounds.
Third Quarter 2016 Financial Results:
- Revenue: Revenue was $28.7
million for the three months ended September 30, 2016,
compared to $0.1 million for the same period in 2015. The
increase was due to the revenue recognized from the License
Agreement with Roche.
- R&D Expenses: Research and
development expenses were $2.8 million for the three
months ended September 30, 2016, compared to $6.7 million
for the same period in 2015. The decrease was primarily due to a
decrease of isunakinra-related development expenses, for which
development activities are no longer ongoing, as well as decreases
in EBI-031 related development expenses due to the License
Agreement with Roche.
- G&A Expenses: General and
administrative expenses were $6.4 million for the three
months ended September 30, 2016, compared to $2.7 million
for the same period in 2015. The increase was primarily due to
increased severance, retention and stock-based compensation
expenses and professional fees related to our review of strategic
alternatives and the acquisition of Viventia.
- Net Income (Loss): Net income
was $19.5 million, or $0.95 per basic share and $0.91 per
diluted share, for the three months ended September 30, 2016,
compared to a net loss of $9.7 million, or $0.50 per
basic and diluted share, for the same period in 2015. The change
was primarily the result of the revenue recognized from the License
Agreement with Roche.
- Cash and Cash Equivalents: Cash
and cash equivalents were $30.7 million as
of September 30, 2016. We believe that our cash and cash
equivalents as of September 30, 2016 will enable us to
fund our operating expenses into 2018.
Events and Presentations:
- Protein & Antibody Engineering
Summit (PEGS) Europe, October 31-November 4, 2016 in Lisbon,
Portugal.
- European Antibody Congress, November
14-16, 2016 in Basel, Switzerland.
Conference Call Information:
Eleven Biotherapeutics’ management team will host a conference
call and audio webcast today at 8:30 a.m. ET to discuss the third
quarter 2016 results and provide a corporate update. To access the
conference call, please dial (844) 831-3025 (domestic) or (315)
625-6887 (international) at least five minutes prior to the start
time and refer to conference ID 14447038.
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.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a late-stage clinical oncology
company advancing a broad pipeline of novel product candidates
based upon the Company's targeted protein therapeutics (TPTs)
platform. The Company's TPTs incorporate a tumor-targeting antibody
fragment and a protein cytotoxic payload into a single protein
molecule in order to achieve focused tumor cell killing. The TPTs
fusion protein construction provides enhanced linker stability and
an efficient and cost effective manufacturing process. The Company
believes its TPT approach offers significant advantages in treating
cancer over existing antibody drug conjugate technologies. The
Company believes its TPTs provide effective tumor targeting with
broader cancer cell-killing properties than are achievable with
small molecule payloads that require tumor cell proliferation and
face multi-drug resistance mechanisms. Additionally, the Company
believes that its TPT’s cancer cell-killing properties promote an
anti-tumor immune response that will potentially combine well with
immune oncology drugs such as checkpoint inhibitors. For more
information please refer to 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 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 and
Quarterly Reports on Form 10-Q filed with the Securities and
Exchange Commission, the "Risk Factors of Viventia's Business"
filed as Exhibit 99.2 to the Company's Current Report on Form 8-K
filed with the Securities and Exchange Commission on September 21,
2016 and other reports on file 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. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (unaudited) (in thousands, except per
share data) Three
Months Ended September 30, Nine Months Ended
September 30,
2016
2015
2016
2015
Total revenue $ 28,650 $ 67
$
29,156
$ 425 Operating expenses: Research and development 2,754 6,745
10,684 18,252 General and administrative 6,366
2,681 11,984 7,531
Total operating expenses 9,120 9,426
22,668 25,783 Income
(loss) from operations 19,530 (9,359 ) 6,488 (25,358 ) Other income
(expense), net (43 ) (334 )
(1,066 ) 2,235 Net income (loss) $ 19,487 $
(9,693 ) $ 5,422 $ (23,123 ) Net income (loss)
per share —basic $ 0.95 $ (0.50 ) $ 0.27
$ (1.23 ) Weighted-average number of common shares used in
net income (loss) per share —basic 20,495
19,345 20,004 18,806
Net income (loss) per share —diluted $ 0.91 $ (0.50 )
$ 0.26 $ (1.23 ) Weighted-average number of
common shares used in net income (loss) per share —diluted
21,423 19,345 20,796
18,806
ELEVEN BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
(in thousands) September
30, December 31, 2016
2015 Assets Current assets: Cash and
cash equivalents $ 30,716 $ 36,079 Restricted cash 94 - Prepaid
expenses and other current assets 952 232 Due from related party
50 - Total current assets 31,812 36,311
Property and equipment, net 894 407 Restricted cash 10 94
Intangible assets 36,200 Goodwill 10,312 Other assets 350
13 Total assets $ 79,578 $
36,825
Liabilities and stockholders' equity
Current liabilities: Accounts payable $ 1,761 $ 1,246 Accrued
expenses 2,492 1,794 Deferred revenue 1,250 406 Due to related
party 697 - Other current liabilities 65 - Notes payable, current
portion - 4,134 Total current
liabilities 6,265 7,580 Other liabilities - 423 Notes payable, net
of current portion - 9,763 Due to related party 117 Warrant
liability 77 115 Deferred tax liability 9,774 - Contingent
consideration 21,900 - Stockholders' equity: Common stock 24
20 Additional paid-in capital 161,201 144,126 Accumulated deficit
(119,780 ) (125,202 ) Total stockholders' equity
41,445 18,944 Total liabilities
and stockholders' equity $ 79,578 $ 36,825
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161114005376/en/
Eleven BiotherapeuticsLeah Monteiro,
617-444-8556Leah.monteiro@elevenbio.com
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