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Eleven Biotherapeutics Reports First Quarter Financial Results and Pipeline Updates

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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 Information
The 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 Biotherapeutics
Eleven 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 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;
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 net
loss per
share —basic and diluted
35,674 24,610

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