Company to Host Conference Call in Conjunction
with AUA Presentation on May 21, 2018
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
pipeline updates and operating results for the quarter ended March
31, 2018.
“2018 is set to be a transformational year for the company and,
already in the first quarter, we have made important progress in
advancing our lead program, Vicinium™, for high-grade non-muscle
invasive bladder cancer, or NMIBC,” said Stephen Hurly, president
and chief executive officer of Eleven Biotherapeutics. “Our Phase 3
registration trial, the VISTA Trial, investigating Vicinium for
patients with high-grade NMIBC, is progressing well and recently
completed enrollment. We look forward to presenting three-month
data from the trial in an oral presentation at the American
Urological Association Annual Meeting on May 21st, a significant
catalyst for the company and our Vicinium program. High-grade NMIBC
is a disease for which there is a desperate need for new treatment
options, and we look forward to further exploring Vicinium as a
potential treatment for these patients.”
Pipeline Progress and
Updates
- Eleven Biotherapeutics will present
three-month data from its ongoing Phase 3 VISTA Trial, which is
evaluating Vicinium for the treatment of patients with high-grade
NMIBC who have been previously treated with bacillus
Calmette-Guérin (BCG). The data will be presented during a plenary
session on Monday, May 21, 2018 at 11:00 a.m. PDT at the American
Urological Association Annual Meeting being held in San Francisco.
In March 2018, the company announced enrollment completion in the
VISTA Trial.
- In April 2018, Eleven Biotherapeutics
presented preclinical data from its deBouganin program at the 2018
American Association for Cancer Research Annual Meeting. DeBouganin
is a potent deimmunized plant-based toxin designed for systemic use
in the treatment of cancer and other indications. The data
presented suggest that VB6-845d, a next generation ADC that is
composed of an anti-EpCAM antibody fragment fused to deBouganin,
mediates tumor cell killing by an immunogenic cell death (ICD)
pathway. The potential cross-priming effect initiated by
VB6-845d-induced ICD suggests that VB6-845d in combination with
immune checkpoint inhibitors may enhance their effectiveness in
EpCAM-positive epithelial cancers. Additionally, in collaboration
with Crescendo Biologics, the company presented data demonstrating
that a potent fusion protein comprised of the company’s deBouganin
payload and Crescendo’s Humabody® is expressible as a soluble
protein in E. coli supernatant and capable of potent killing of
cancer cell lines.
First Quarter 2018 Financial
Results
- Cash Position: Cash and cash
equivalents were $19.7 million as of March 31, 2018, compared to
$20.3 for the same period in 2017.
- Revenue: There was no revenue
for the quarter ended March 31, 2018, compared to $0.4 million for
the same period in 2017. The decrease was due to a reduction in
revenue recognized from the company’s license agreement with F.
Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
- R&D Expenses: Research and
development expenses were $3.3 million for the quarter ended March
31, 2018, compared to $2.9 million for the same period in 2017. The
increase was due primarily to increases in clinical costs.
- G&A Expenses: General and
administrative expenses were $2.0 million for the quarter ended
March 31, 2018, compared to $2.2 million for the same period in
2017. The decrease was due primarily to reductions in legal and
professional costs.
- Net Loss: Net loss was $4.0
million, or $0.11 per share, for the quarter ended March 31, 2018,
compared to net loss of $6.1 million, or $0.25 per share, for the
same period in 2017. The decrease was due primarily to the change
in the fair value of contingent consideration.
- Financial Guidance: Following
Eleven Biotherapeutics’ $10.0 million financing in March 2018 and
receipt of approximately $4.2 million from the exercise of common
stock warrants through mid-May, the company maintains it will have
capital to fund its current operating plans into early 2019.
Conference Call InformationThe company will host a
conference call on May 21, 2018 at 5 p.m. ET to review the data
being presented at AUA. To participate in the conference call,
please dial (844) 831-3025 (domestic) or (315) 625-6887
(international) and refer to conference ID 4453267. The webcast can
be accessed in the Investor Relations section of the company's
website at www.elevenbio.com. The replay of the webcast will be
available in the investor section of the company’s website at
www.elevenbio.com for 60 days following the call.
About Vicinium™Vicinium™, also known as VB4-845, is
Eleven Biotherapeutics’ lead product candidate and is a
next-generation antibody-drug conjugate (ADC), developed using the
company’s proprietary Targeted Protein Therapeutics platform, for
the treatment of high-grade non-muscle invasive bladder cancer
(NMIBC). 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 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 high-grade NMIBC in
patients who have previously received two courses of bacillus
Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive.
Three-month data from the ongoing trial are planned for
presentation at the 2018 American Urological Association Annual
Meeting on May 21, 2018, with 12-month data anticipated in
mid-2019. 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 BiotherapeuticsEleven Biotherapeutics, Inc.
is a late-stage clinical company advancing next-generation
antibody-drug conjugate therapies for the treatment of cancer based
on the company’s Targeted Protein Therapeutics platform. The
company’s lead program, Vicinium™, also known as VB4-845, is
currently in a Phase 3 registration trial, the VISTA Trial, for the
treatment of high-grade non-muscle invasive bladder cancer.
Three-month results from the VISTA Trial are planned for
presentation at the 2018 American Urological Association Annual
Meeting on May 21, 2018, with 12-month data anticipated in
mid-2019. 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 StatementsAny
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; expectations regarding
the adequacy of our existing capital resources to fund our
operations through early 2019; 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.CONDENSED CONSOLIDATED
BALANCE SHEETS(unaudited)(in thousands)
March 31,2018 December
31,2017 Assets Current assets: Cash and
cash equivalents $ 19,688 $ 14,680 Prepaid expenses and other
current assets 638 301 Total current
assets 20,326 14,981 Property and equipment, net 473 522 Restricted
cash
10
10 Intangible assets 46,400 46,400 Goodwill 13,064 13,064 Other
assets 19 120 Total assets
$
80,292
$ 75,097
Liabilities and stockholders'
equity Current liabilities: Accounts payable $ 1,393 $ 907
Accrued expenses 3,853 3,813 Total
current liabilities 5,246 4,720 Other liabilities 260 215 Deferred
tax liability 12,528 12,528 Contingent consideration 38,400 39,600
Stockholders' equity: Common stock 43 35 Additional paid-in
capital 180,109 170,330 Accumulated deficit (156,294 )
(152,331 ) Total stockholders' equity 23,858
18,034 Total liabilities and stockholders' equity $
80,292 $ 75,097
ELEVEN BIOTHERAPEUTICS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(unaudited)(in thousands, except
per share data) Three Months
Ended March 31, 2018
2017 Total revenue $ - $ 425 Operating
expenses: Research and development 3,255 2,874 General and
administrative 1,952 2,213 (Gain) loss from change in fair value of
contingent consideration (1,200 ) 1,500 Total
operating expenses 4,007 6,587 Loss
from operations (4,007 ) (6,162 ) Other income, net 44
101 Net loss and comprehensive loss $ (3,963 )
$ (6,061 ) Net loss per share —basic and diluted $ (0.11 ) $ (0.25
) Weighted-average number of common shares used in netloss per
share —basic and diluted 35,674 24,610
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version on businesswire.com: https://www.businesswire.com/news/home/20180515006611/en/
THRUSTMonique Allaire, 617-895-9511monique@thrustir.comorAlicia
Davis, 910-620-3302alicia@thrustir.com
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