Full Press Release Details
Reports Financial Results for 3rd
Quarter and First Nine Months 2016
Phase 1 trial on-going
Successful cGMP Manufacturing for UCART123
cash position of $295 million1
as of September 30, 2016
Additional grant of patent with broad claims covering fundamental use of
gene editing technologies
Revenues and other income of $12 million2
Adjusted loss attributable to shareholders3
NEW YORK--(BUSINESS WIRE)--November 22, 2016--Regulatory News:
Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq:
CLLS), a biopharmaceutical company focused on developing immunotherapies
based on gene edited CAR T-cells (UCART), today announced its results
for the three-month period ended September 30, 2016 and for the
nine-month period ended September 30, 2016.
Recent Corporate Highlights
UCART19 in collaboration with Servier / Pfizer
On June 20, 2016, Cellectis announced that the first patient in
Servier's UCART19 Phase 1 clinical trial had been dosed. The UCART19
Phase 1 clinical trial in ALL and CLL patients is conducted at two
clinical sites in the UK - at the Great Ormond Street Hospital (GOSH),
part of UCL, for the pediatric arm of the trial, and at Kings College
London for the adult arm of the study.
Interim data from the UCART19 Phase 1 clinical trial is expected to be
announced at a scientific meeting in H1 2017.
On November 15, 2016, Cellectis announced the successful completion of
large scale production runs of UCART123, according to cGMP standards.
Cellectis is planning to file an IND for a Phase 1 clinical trial in
AML and BPDCN patients by YE 2016 in collaboration with the Weill
Cornell Medical College and the MD Anderson Cancer Center.
Weill Cornell will present pre-clinical data on UCART123 in an oral
presentation at the 58th American Society of Hematology (ASH) Annual
Meeting and Exposition. The meeting will be held from December 3 to 6,
Cellectis and Pfizer are making advances in their partnered programs.
Notably, Pfizer will present on the "Preclinical Evaluation of
Allogeneic Anti-BCMA Chimeric Antigen Receptor T Cells with Safety
Switch Domains and Lymphodepletion Resistance for the Treatment of
Multiple Myeloma" in an oral presentation at ASH in December 2016.
IP / Patent Portfolio
Issuance of U.S. patent 9,458,439 - which claims gene inactivation by
use of chimeric restriction endonucleases. This patent, granted by the
USPTO to the Institut Pasteur and Boston Children's Hospital, naming
Dr. Andr Choulika and Pr. Richard C. Mulligan as co-inventors, is
exclusively licensed to Cellectis.
Cellectis won EuropaBio's 2016 Most Innovative European Biotech SME
Award for the healthcare category. The Awards program is a unique
annual initiative that recognizes innovative biotech small- and
medium-sized enterprises (SMEs) in Europe and the crucial role that
they play in answering some of society's greatest challenges through
Cellectis will participate in the upcoming Oppenheimer Life Sciences
Summit being held in NYC on November 29, 2016 and will be presenting
at the Piper Jaffray 28th Annual Health Care Conference on November
Calyxt - Cellectis' plant science subsidiary
Calyxt expanded its patent portfolio with U.S. patent 9,458,439, which
encompasses broad uses of technologies such as CRISPR/Cas9, Zinc
Finger Nucleases and TAL-effector Nucleases for plant gene editing.
On October 20, 2016 Cellectis hosted, along with its agricultural
biotech subsidiary Calyxt, the world's first dinner made with gene
edited foods in New York.
Calyxt has completed the 2016 expansion of its high-oleic/no trans-fat
soybean variety (CAL1501) in the U.S. with a production of 1,200 tons
of beans. In Spring 2016, Calyxt planted 942 acres (381 hectares) in
six U.S. states - Illinois, Iowa, Michigan, Minnesota, South Dakota
and Wisconsin. To date, the Company has harvested approximately 45,000
bushels with the intent to use a substantial portion of the harvest
for its first industrial scale crush.
Cellectis' consolidated financial statements have been prepared in
accordance with International Financial Reporting Standards, or IFRS, as
issued by the International Accounting Standards Board ("GAAP").
Third Quarter 2016 Financial Results
Cash: As of September 30, 2016, Cellectis had 264.0 million in
total cash, cash equivalents and current financial assets compared to
269.7 million as of June 30, 2016. This decrease of 5.7 million
notably reflects (i) the net cash flows used in operating activities of
1.7 million, which includes 9.2 million of cash receipts in the third
quarter of 2016 in connection with the achievement of two milestones
under our collaboration agreement with Servier that occurred during the
second quarter of 2016, and (ii) capital expenditures of 2.2 million.
The change was also attributable to the unrealized negative translation
effect of exchange rate fluctuations on our U.S. dollar cash, cash
equivalents and current financial assets of 1.6 million.
Revenues and Other Income: During the quarters ended September
30, 2015 and 2016, we recorded 10.0 million and 11.3 million,
respectively, in revenues and other income. This is mainly due to (i)
the increase of 2.5 million in collaboration revenues, notably due to
the agreement to provide Servier with raw materials and batches of
UCART19 products, partly offset by (ii) the decrease of 0.3 million in
research tax credit and 0.8 million in subsidies.
Total Operating Expenses and Other Operating Income: Total
operating expenses and other operating income for the third quarter of
2016 were 22.9 million, compared to 23.4 million for the third quarter
of 2015. The non-cash stock-based compensation expenses included in
these amounts were 12.1 million and 9.5 million, respectively.
R&D Expenses: For the quarters ended 2015 and 2016, research
and development expenses decreased by 2.3 million from 16.2 million in
2015 to 13.8 million in 2016. Personnel expenses decreased by 1.1
million from 10.3 million in 2015 to 9.2 million in 2016, notably due
to a 2.5 million decrease in social charges on stock options and free
share grants, partly offset by a 0.4 million increase in wages and