-- Phase 3 Enrollment on Track to Complete in
Q1 2018 --
-- Topline 3-Month Data from Phase 3 Trial of
Vicinium™ on Track for Mid-2018 --
-- Strengthened Balance Sheet with $8.0 million
Capital Raise --
Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage
clinical oncology company advancing novel product candidates based
on its Targeted Protein Therapeutics (TPTs) platform, today
reported financial results for the quarter ended September 30,
2017.
“I am very pleased with our progress this quarter. In addition
to strengthening our balance sheet with a successful public
offering in November, we also made strong progress during this
quarter on our Phase 3 clinical trial examining Vicinium™ in
patients with non-muscle invasive bladder cancer (NMIBC),” said
Stephen Hurly, President and Chief Executive Officer of Eleven
Biotherapeutics. “We are driving our Phase 3 enrollment forward and
expect to achieve full enrollment in Q1 2018. The Company also
remains on track to report top-line three-month data from our
registration trial in mid-2018 with sufficient capital to carry us
through this critical milestone. Also, we are excited that the
combination trial of Vicinium™ and durvalumab, Astra Zeneca’s
checkpoint inhibitor, has opened at the National Cancer Institute
and we will be gathering immune biomarker data that we believe will
provide insight into the complementary mechanism of action between
checkpoint inhibitors and our TPT platform.”
Third Quarter Results, Recent Business Highlights and
Anticipated Upcoming Milestones:
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 NMIBC in subjects who have previously
received two courses of Bacillus Calmette-Guérin (BCG) and whose
disease is now BCG-unresponsive. The company also has a Cooperative
Research and Development Agreement (CRADA) with the National Cancer
Institute (NCI) evaluating Vicinium™ in combination with
AstraZeneca’s checkpoint inhibitor, durvalumab.
- In September, the Company announced
completion of the manufacturing of Vicinium™ necessary for the
ongoing Phase 3 registration trial in patients with NMIBC, and the
CRADA trial with the NCI.
- Completion of enrollment for the Phase
3 registration clinical trial of Vicinium™ is expected in the first
quarter of 2018.
- Topline three-month data from the Phase
3 registration clinical trial of Vicinium™ is expected mid-2018 and
topline twelve-month data is expected in the second quarter of
2019.
- Initiation of a Phase 1 trial of
Vicinium™ and durvalumab through the NCI CRADA will collect immune
response biomarker data in patients with NMIBC and is expected to
commence in the fourth quarter of 2017, with initial biomarker data
expected in the third quarter of 2018.
Corporate:
- In October, the Company announced the
appointment of Richard F. Fitzgerald as Interim Chief Financial
Officer, adding extensive capital raising and transaction execution
experience to Eleven’s management team.
- In November, the Company completed a
public offering of 5,525,000 shares of its common stock, pre-funded
warrants to purchase an aggregate of 4,475,000 shares of common
stock, and common warrants to purchase up to an aggregate of
10,000,000 shares of common stock, raising approximately $8.0
million in gross proceeds and $7.0 million in net proceeds, after
deducting underwriting discounts and commissions and estimated
expenses payable by the Company.
TPT Pipeline:
Eleven’s pipeline includes additional locally delivered product
candidates, as well as a systemic TPT platform.
- 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). In Phase 1 and 2 clinical
trials, Proxinium™ demonstrated anti-tumor activity in both
injected as well as un-injected tumors. The Company plans to
evaluate Proxinium™ in a Phase 1/2a clinical trial in combination
with a checkpoint inhibitor and is actively seeking partners for a
combination program.
- VB6-845d is a systemically-administered
TPT utilizing a proprietary, highly potent, de-immunized plant
toxin, deBouganin, for the treatment of solid tumors. The Company
plans to file an investigational new drug (IND) application for
VB6-845d and initiate a Phase 1 trial, once funding or a partner is
secured for this program.
The Company has deferred further development of Proxinium™ and
VB6-84d in order to focus its efforts and resources on the
advancement of its Phase 3 registration trial of Vicinium™. The
Company is also exploring partnering and collaboration strategies
to move these additional product candidates forward.
Third Quarter 2017 Financial Results:
- Cash Position: Cash and cash
equivalents were $11.3 million as of September 30, 2017, compared
to $25.3 million as of December 31, 2016. These amounts do not
include the approximately $7.0 million of net proceeds from the
Company’s November 2017 public offering.
- Revenue: Eleven did not record
any revenue for the three months ended September 30, 2017, compared
to revenue of $28.7 million for the same period in 2016. This
decrease was due to revenue recognized in 2016 from the Company’s
License Agreement with Roche. The next licensing milestone payment
expected from Roche, if any, will be triggered upon commencement of
a Phase 2 clinical trial by Roche.
- R&D Expenses: Research and
development expenses were $3.6 million for the three months ended
September 30, 2017, compared to $2.8 million for the same period in
2016. This increase was primarily due to higher costs incurred for
the Company’s ongoing Phase 3 clinical trial for NMIBC that were
partially offset by the absence of costs associated with the
product candidate licensed to Roche in 2016 and lower compensation
related costs.
- G&A Expenses: General and
administrative expenses were $1.6 million for the three months
ended September 30, 2017, compared to $6.4 million for the same
period in 2016. This decrease was driven primarily by a reduction
in severance, retention and stock-based compensation and
professional fees related to the Company’s 2016 review of strategic
alternatives and the acquisition of Viventia Bio, Inc.
- Net Loss: Net loss was $9.1
million, or $0.37 per basic and diluted share, for the three months
ended September 30, 2017, compared to net income of $19.5 million,
or $0.95 per basic share and $0.91 per diluted share, for the same
period in 2016. The change was primarily the result of revenue
recognized in 2016 from the Company’s License Agreement with
Roche.
- Financial Guidance: Based on
current operating plans, the Company anticipates that cash at
September 30, 2017, plus the net $7.0 million raised in November
2017, will fund research and development programs and operations
into mid-2018.
About Eleven Biotherapeutics:
Eleven Biotherapeutics, Inc. is a late-stage, clinical oncology
company advancing 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 cytotoxic
protein payload within a single protein molecule in order to
achieve focused tumor cell killing. 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 generally achievable with small
molecule cytotoxic payloads that require tumor cell proliferation
to be effective and can face challenges overcoming multi-drug
resistance mechanisms within tumor cells. 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 (License Agreement) with
F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc., 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, the Company’s projected use of
proceeds from its November 2017 public offering, 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 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 AND COMPREHENSIVE INCOME (LOSS) (unaudited)
(in thousands, except per share data)
Three Months Ended September 30,
Nine Months Ended September 30,
2017
2016
2017
2016
Total revenue $ - $ 28,650 $ 425 $ 29,156 Operating
expenses: Research and development 3,619 2,754 9,402 10,684 General
and administrative 1,631 6,366 6,085 11,984 Loss from change in
fair value of contingent consideration 3,900 -
7,600 - Total operating expenses 9,150 9,120
23,087 22,668 (Loss) income from operations (9,150)
19,530 (22,662) 6,488 Other income (expense), net 45
(43) 180 (1,066) Net (loss) income and comprehensive
(loss) income $ (9,105) $ 19,487 $ (22,482) $ 5,422 Net (loss)
income per share —basic $ (0.37) $ 0.95 $ (0.91) $ 0.27
Weighted-average number of common shares used in net (loss) income
per share —basic 24,691 20,495 24,663
20,004 Net (loss) income per share —diluted $ (0.37) $ 0.91 $
(0.91) $ 0.26 Weighted-average number of common shares used in net
(loss) income per share —diluted 24,691 21,423
24,663 20,796
ELEVEN BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS (unaudited) (in thousands)
September 30, December 31,
2017 2016 Assets Current assets:
Cash and cash equivalents $ 11,338 $ 25,342 Prepaid expenses and
other current assets 770 585 Total current assets
12,108 25,927 Property and equipment, net 585 796 Restricted cash
10 10 Intangible assets 46,400 60,500 Goodwill 13,064 16,864 Other
assets 101 - Total assets $ 72,268 $ 104,097
Liabilities and stockholders' equity Current
liabilities: Accounts payable $ 1,366 $ 1,667 Accrued expenses
2,915 1,774 Deferred revenue - 425 Due to related party 123
114 Total current liabilities 4,404 3,980 Other liabilities
170 - Warrant liability - 5 Deferred tax liability 12,528 16,335
Contingent consideration 38,100 45,100 Stockholders' equity:
Common stock 25 25 Additional paid-in capital 162,825 161,963
Accumulated deficit (145,784) (123,311) Total
stockholders' equity 17,066 38,677 Total
liabilities and stockholders' equity $ 72,268 $ 104,097
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171120005359/en/
Stern Investor Relations, Inc.Michael Schaffzin,
212-362-1200michael@sternir.com
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