Full Press Release Details
Reports Fourth Quarter and Full Year 2015 Financial Results
track with submission of UCART19 Clinical Trial Application; Application
Filed with MHRA (UK)
Encouraging data from the First-in-Human compassionate use of UCART19
opt-in by Servier into UCART19; amendment with improved economics
Successful production of UCART19 batches in GMP conditions; the first
UCART product candidate
track with GMP UCART123 production; IND filing expected later in 2016
Revenues and other income of $61.4 million ( 56.4 million), with an
adjusted net income of $10.3 million ( 9.5 million)
2015 year-end cash position of $350 million ( 314 million)
NEW YORK--(BUSINESS WIRE)--March 14, 2016--Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq: CLLS),
a biopharmaceutical company focused on developing immunotherapies based
on gene-edited CAR T-cells (UCART), today reported business highlights
and financial results for the fourth quarter and year ended December 31,
"In 2015, Cellectis has reached a key inflection point by applying the
first in-human off-the-shelf UCART product candidate. The production of
UCART19 in GMP conditions was the gating factor to the filing of the
Clinical Trial Application. We believe that our UCART product candidates
have the potential to turn an individualized CAR T therapy into
universal off-the-shelf products, bringing hope to patients with unmet
medical needs. Our U.S. IPO in March 2015 strengthened our financial
position to fund our operations over the next years. Our collaborations
with Servier and Pfizer are on a strong momentum, and we are forward
looking to generating clinical data." said Andr Choulika, Chairman and
Chief Executive Officer of Cellectis.
Recent Corporate Highlights
January 2016 - Start of technology transfer for GMP manufacturing of
UCART123 clinical batches, Cellectis' wholly-owned lead product
candidate targeting AML and BPDCN, to CELLforCURE, which will
be in charge of implementing GMP manufacturing processes designed and
developed by Cellectis.
October 2015 - Successful completion of a series of three production
runs of UCART19, Cellectis' lead TALEN gene-edited product candidate,
confirming the implementation of Cellectis' manufacturing process in
December 2015 - Submission of a Clinical Trial Application (CTA) to
the Medicines & Healthcare products Regulatory Agency (MHRA)
requesting approval to initiate Phase I clinical trial of UCART19
product candidate in acute lymphoblastic leukemia (ALL) in the United
November 2015 - Treatment by physicians at University College London's
Great Ormond Street Hospital (GOSH) of a young patient suffering from
aggressive ALL using UCART19 product candidate on a compassionate use
basis in June 2015. The encouraging data of this first-in-human
clinical use of UCART19 was subsequently presented at the 57th
American Society of Hematology (ASH) Annual Meeting in December 2015.
IND filing for first wholly-owned product candidate, UCART123,
expected by year end 2016, which would be followed by UCARTCS1.
November 2015 - Early exercise of Servier's option on UCART19 product
candidate and announcement by Servier and Pfizer of a new global
license and collaboration agreement between them. Cellectis received
35.6 million ($38.5 million) upfront from Servier and may receive up
to 895 million ($974 million) in further potential option exercise
fees and development, clinical and sales milestones, in addition to
royalties on sales and research and development costs reimbursements.
April 2015 - Opening of R&D labs and offices in New York City with
March 2015 - Completion of Cellectis' U.S. IPO on the Nasdaq, raising
more than $228 million of gross proceeds.
Strong year end 2015 cash position of $342 million ( 314 million),
which we believe will be sufficient to fund operations until year end
Alliances remain strong, creating economies of scale in manufacturing
January 2016 - Appointment of Dr. Loan Hoang-Sayag as Chief Medical
Officer. Dr. Hoang-Sayag was Senior Director of Medical Science at
Quintiles Transnational prior to joining Cellectis.
January 2016 - Publication of a study in Scientific Reports, a Nature
Publishing Group journal, describing the design and development of a
new CAR architecture with an integrated switch-on system that provides
control over CAR T-cell functions.
September 2015 - Entry into a research and development alliance with
MD Anderson Cancer Center aimed at bringing novel cellular
immunotherapies to patients suffering from different types of liquid
June 2015 - Entry into a research and development alliance with The
Weill Cornell Medical College (WCMC) aimed at bringing novel cellular
immunotherapies to patients suffering from acute myeloid leukemia.
Cellectis continues to be on the forefront of R&D with multiple
publications on gene-editing applications and proprietary CAR
Calyxt, Inc. ("Calyxt")
March 2016 - Acquisition of land for new headquarters facility. The
new facility will incorporate office space, research labs, green
houses as well as land for field trials.
December 2015 - Confirmation by the USDA that Calyxt's powdery
mildew-resistant wheat product candidate falls outside the scope of
December 2015 -Research collaboration and licensing agreement signed
with Plant Bioscience Limited for trait development in wheat, rice and
corn. This new collaboration expands the relationship between Calyxt
and Plant Bioscience Limited, boosts the trait development pipeline at
Calyxt for gluten-reduced wheat, and provides access to traits in two
new crops: rice and corn.
November 2015 - Completion of first field trial of Calyxt's
cold-storable potato product candidate in Minnesota, Wisconsin and
November 2015 - Harvest of over one ton of high oleic soybean product
candidate, after completion of second year of field trial.
July 2015 - Exclusive worldwide license granted to Calyxt by
University of Minnesota under the patent rights of the
PCT/US2013/046495 patent family entitled "Gene Targeting Using
Replicating DNA Molecules."
July 2015 - Calyxt named among the "50 Smartest Companies in 2015" by
MIT Technology Review.
June 2015 - New wheat program added to Calyxt's pipeline. The trait
provides endogenous resistance to powdery mildew of wheat.