Full Press Release Details
Quarter and Full Year 2016 Financial Results
approval to conduct Phase I clinical trials for UCART123 in AML &
Phase I clinical trials ongoing in ALL patients; partial data
presented at the NIH's RAC's meeting in December 2016
of Cellectis' Clinical Advisory Board
cash position of $291 million2
( 276 million) as of December 31, 2016
and other income of $56 million3
( 51 million) in 2016
non-cash stock based compensation expense, Adjusted net loss4
( 8 million) for full year 2016
NEW YORK--(BUSINESS WIRE)--March 6, 2017--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 December 31, 2016 and for the year
ended December 31, 2016.
Earnings Call Details
Cellectis will host an earnings call on March 7, 2017 at 8:00am Eastern
Time to discuss its financial results and provide a general business
Live PARTICIPANT Dial-In (Toll-Free US &
Canada): 877-407-3104
Live PARTICIPANT Dial-In (International): +1
Conference ID #: 13625168
Dial-In (Toll Free US & Canada): 877-660-6853
(International): +1 201-612-7415
Expiration Date: 3/21/17
Webcast URL (Archived for 12 months): http://cellectis.equisolvewebcast.com/q4-2016
RECENT CORPORATE HIGHLIGHTS
Cellectis - Therapeutics
UCART123 - Cellectis' most advanced, wholly owned TALEN
gene-edited product candidate
Pre-clinical data presented at the 2016 American Society of Hematology
(ASH) annual meeting by Dr. Monica Guzman, MD, Weill Cornell, showed
long-lasting molecular remission in mice, using UCART123, compared to
Successful National Institutes of Health's (NIH) Recombinant DNA
Advisory Committee's (RAC) meeting with unanimous approval of Phase I
clinical trials for UCART123 in acute myeloid leukemia (AML) and
blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Investigational New Drug (IND) approval received from the U.S. Food
and Drug Administration (FDA) to conduct Phase I clinical trials in
patients with AML and BPDCN.
First clinical trial approval by the FDA for an allogeneic,
"off-the-shelf" gene-edited CAR T-cell product candidate.
AML clinical program to be led, at Weill Cornell, by Gail J. Roboz,
MD, Director of the Clinical and Translational Leukemia Programs and
Professor of Medicine.
BPDCN clinical program to be led, at MD Anderson Cancer Center, by
Naveen Pemmaraju, MD, Assistant Professor, and Hagop Kantarjian, MD,
Professor and Department Chair, Department of Leukemia, Division of
Successful cGMP manufacturing runs of UCART123 at large scale, to
provide doses for initiating planned Phase I clinical trials in AML
UCART19, exclusively licensed to Servier
Phase I clinical trials in pediatric and adult ALL patients are
ongoing at University College London (UCL) and Kings College London
(KCL), UK, sponsored by Servier. Additional sites in other European
countries are planned to be opened subject to approval of concerned
Partial data presented on first 7 patients treated with UCART19 at
NIH's Recombinant DNA Advisory Committee (RAC) meeting in December
Pfizer, in collaboration with Servier, plans to open sites in the U.S.
for the ongoing Phase I clinical trials in adult ALL patients, as
presented at the RAC meeting in December 2016.
Scientific Publications
Publication of a study in Scientific Reports, a Nature Publishing
Group journal, describing a novel approach to a CAR design with an
integrated environmental signal utilizing oxygen concentration to
manipulate the CAR T-cell response.
Clinical Advisory Board
Formation of a Clinical Advisory Board (CAB) comprising leading
experts in the hematologic malignancies / stem cell transplant,
immunotherapy and hematology-oncology clinical research fields to
serve as a strategic resource to Cellectis in connection with the
clinical development of UCART123.
Calyxt - Cellectis' plant science subsidiary
Publication of a study in BMC Plant Biology describing the use of
genome editing technology to modulate soybean oil composition for
increased shelf-life, higher frying stability and improved nutritional
Calyxt completed an expansion of its high-oleic/no trans-fat soybean
variety (CAL1501) in the U.S. with a production of 1,200 tons of
Cellectis' consolidated financial statements have been prepared in
accordance with International Financial Reporting Standards, or IFRS, as
issued by the International Accounting Standards Board ("IASB"). The
audit procedures have been carried out by the independent auditors and
their audit report relating to the certification of the financials is in
the process of being issued. The audited report for Cellectis'
consolidated financial statements will be included in the Company's
Fourth quarter 2016 Financial Results
Cash: As of December 31, 2016 Cellectis had 276.2 million in
total cash, cash equivalents and current financial assets compared to
264.0 million as of September 30, 2016. This increase of 12.2 million
notably reflects (i) the receipt of R&D tax credits of 9.2 million,
(ii) proceeds of 7.0 million related to the supply agreement with
Servier, (iii) the unrealized positive translation effect of exchange
rate fluctuations on our U.S. dollar cash, cash equivalents and current
financial assets of 12.1 million, partially offset by (iv) other net
cash flows used by operating activities of 15.0 million and (v) fixed
assets expenditures of 1.1 million.
Revenues and Other Income: During the quarters ended December 31,
2015 and 2016, we recorded 29.2 million and 12.1 million,
respectively, in revenues and other income. This decrease is mainly due