[September 30, 2014] |
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Cellectis: First-Half 2014 Financial Results
PARIS --(Business Wire)--
Regulatory News:
Cellectis SA (Paris:ALCLS) (Alternext: ALCLS.PA), an expert in
developing immunotherapies based on engineered allogeneic CART cells
(UCART), presents its first-half 2014 consolidated financial statements
to June 30, 2014, approved by the Board of Directors at its meeting held
on September 29.
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Total operating revenue is €13.8 M (as compared to €6.9 M for the
first six months of 2013), i.e. an increase of 100%. Total operating
revenue does not include revenue arising from the agreement signed
with Pfizer, which will come into effect only from the second half of
2014.
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Operating results are notably improved, with losses limited to €2.1 M
(excluding Cellectis AB) as compared to €16.5 M for the first six
months of 2013.
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Net results show a loss of €5 M, which is in sharp contrast to the
loss recorded for the first half of 2013, which amounted to €18.5 M.
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As at the date of this release, available cash stands at €103 million.
Limited examination procedures have been applied to the summary
half-year consolidated accounts to June 30, 2014. The limited
examination report is currently being issued.
Group results for the first half of 2014 demonstrate the relevance of
the Group's focused therapy strategy and, as a consequence, its
structural reorganization undertaken in early 2013.
A successful implementation of its strategy to focus on therapeutics
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Cellectis is a major player in oncology by way of its groundbreaking
approach based on CART cells. With 15 years of experience of
technological developments at the frontiers of science, Cellectis is
able to engineer T cells with TALEN™ and to develop completely new
CARs (Chimeric Antigen Receptors).
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Servier and the biopharmaceutical company Pfizer are Cellectis' two
exclusive partners in the area of CARTs in oncology. The work of the
three companies relates to a set of 33 targets (markers of cancerous
cells), of which 6 are for Servier, 15 for Pfizer and 12 for Cellectis.
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For each of the six product candidates potentially developed for
Servier, Cellectis could receive more than 105 million euros of
milestone payments as well as royalties on the sales of products.
Likewise, for each of the product candidates potentially developed in
relation to the 15 Pfizer targets, Cellectis could receive more than
145 million euros of milestone payments as well as royalties on the
sales of products. In addition, Pfizer is covering all of Cellectis'
R&D costs incurred within the scope of its collaboration.
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With 103 million euros of cash at present and on the back of a drastic
reduction in its operating costs, the impact of which is starting to
be felt in the first half of 2014, Cellectis is in a strong position
to face the challenges of the coming years and to complete its
transformation to being a market leader in the biopharmaceuticals
sector. The company's cash position is likely to improve by October
28, 2014, the closing date for the exercise of the share subscription
warrants issued in 2011. The exercise of these share subscription
warrants could contribute an additional approximately 20 million euros
to the company's cash position in case of exercise of all the warrants.
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The first-in-man clinical study with its first product UCART19 for the
treatment of chronic lymphocytic leukemia (CLL) and acute
lymphoblastic leukemia (ALL), will begin in the second half of 2015.
Servier has an exclusive option on this product.
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Cellectis' first proprietary product (outside of partnerships),
UCART123 for the treatment of acute myeloid leukemias, should enter
into clinical development in the course of 2016.
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Without making any forecasts, Cellectis is optiistic about the
offering to the general public of Scéil, dedicated to the storage of
induced pluripotent stem (iPS) cells.
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The sale of Cellectis AB marked the final stage of the Company's
therapeutic refocusing, while strengthening its high-potential
subsidiary Cellectis plant sciences Inc., based in New Brighton in
Minnesota.
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In 7 years, by virtue of its Tools and Services business line,
Cellectis has put in place the fundamentals for a worldwide reputation
in genome engineering and in iPS cells. It is by means of the
development of its expertise in research tools that Cellectis has been
successful in developing groundbreaking technology both in
therapeutics and in biotechnological agriculture. A new page in the
history of Cellectis is being written.
Key highlights of the first 9 months of 2014
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On February 17, Cellectis signed a strategic collaboration
agreement with Servier to develop and market six product candidates,
paying €7.55 M on signature and up to €105 M for each of those product
candidates that might be developed.
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On March 24, Cellectis implemented a capital increase of
€20.52 M underwritten by sector-specialist institutional investors
based in the United States, in particular to speed up development of
its individual (non-collaborative) portfolio of CART Cell products for
treating leukemias and solid tumors.
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On March 25, Cellectis received a
recommendation from the European Medicines Agency (EMA (News - Alert)), in
consultation with the European Commission, for the Cellectis UCART19
product candidate in the field of adoptive immunotherapy against
CD19-expressing leukemias and lymphomas. UCART19 fulfils the
definition of an Advanced-Therapy medicinal Product (ATmP) and is thus
eligible for Scientific Advices and Assessment from the EMA Committee
for Advanced Therapies and a possible European Union centralized
marketing authorization.
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On June 5, Cellectis concluded a series of agreements with
Life Technologies in connection with applications of TALEN.
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On June 5, Cellectis signed an agreement with Accelera
(Nerviano Medical Sciences Group) to perform preclinical studies on
its flagship product, UCART19.
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On June 9, the Company announced the signature of an
agreement with CELLforCURE, Europe's largest commercial
industrial facility manufacturing innovative cell therapies and a
subsidiary of the LFB biopharmaceuticals group. This partnership
relates to the production of clinical batches from Cellectis
allogeneic CART cells, with CELLforCURE being responsible for
manufacturing clinical batches of product candidates for Cellectis'
UCART range.
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On June 18, Cellectis and Pfizer entered into
a global collaboration agreement in the field of oncology to develop
immunotherapies based on engineered T cells with Chimeric Antigen
Receptors (CAR-T) directed at select targets. This agreement involves
an upfront payment of $80 million and funding to cover research and
development costs associated with Pfizer-selected targets and the four
Cellectis-selected targets within the collaboration. Cellectis could
receive development, regulatory and commercial milestone payments of
up to €145 million per Pfizer product. Furthermore, Pfizer signed an
investment contract to purchase around 10% of Cellectis' capital
through a reserved capital increase without preferred subscription
right, and the subscription of 2,786,924 newly issued shares at a
price of €9.25 per share.
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Furthermore, on August 29, Cellectis sold its Swedish
subsidiary, Cellectis AB, to the Japanese company Takara Bio Inc. This
operation is a continuation of its focusing on therapeutics reflected
in the concentration of its business in the field of oncology.
The restructuring announced in 2013 and strategic refocusing on
therapeutics and agro-industrial areas implemented over the last 18
months have significantly reduced Group charges and its cash
requirements, thereby markedly enhancing its financial situation and
making the Company's structure more agile, efficient and competitive.
About Cellectis
Cellectis is a biopharmaceutical company focused on oncology. The
company's mission is to develop a new generation of cancer therapies
based on engineered T-cells. Cellectis capitalizes on its 14 years of
expertise in genome engineering - based on its flagship TALEN™ products
and meganucleases and pioneering electroporation Pulse (News - Alert) Agile technology
- to create a new generation of immunotherapies for treating leukemias
and solid tumors. Cellectis' adoptive cancer immunotherapy is based on
the first allogenic T-cells to express a chimeric antigen receptor (CAR)
targeting acute and chronic leukemias. CAR technologies are designed to
target surface antigens expressed on cancer cells. These treatments
reduce the toxicity associated with current chemotherapeutics and have
curative potential. Thanks to its life-science-focused pioneering
genome-engineering technologies, the Cellectis Group is creating
innovative products in multiple fields and with various target markets.
Cellectis is listed on the Alternext market (ticker: ALCLS). To find out
more about us, visit our web site: www.cellectis.com
Disclaimer
This press release contains certain forward-looking statements
concerning Cellectis and its business. These forward looking statements
can be identified by the use of forward looking terminology, including
the terms "anticipates", "believes", "estimates", "expects", "intends",
"may", "plans", "projects", "should" or "will", or, in each case, their
negative or other variations or comparable terminology, or by
discussions of strategy, plans, objectives, goals, future events or
intentions. Such forward-looking statements are based on assumptions
that Cellectis considers to be reasonable. However, there can be no
assurance that the forecasts or objectives contained in such
forward-looking statements will be confirmed or materialized, which
forecasts and objectives are subject to numerous risks including the
risks set forth in the 2013 financial annual report of Cellectis (a copy
of which is available on www.cellectis.com)
and to developments in general economic conditions, financial markets
and the markets in which Cellectis operates. The forward-looking
statements contained in this press release are also subject to risks not
yet known to Cellectis or not currently considered material by
Cellectis. The occurrence of all or part of such risks could cause
actual results, financial conditions, performance or achievements of
Cellectis to be materially different from such forward-looking
statements. This press release and the information that it contains do
not constitute an offer to sell or subscribe for, or a solicitation of
an offer to purchase or subscribe for, Cellectis shares in any country.
Financial Tables Not Included
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