Full Press Release Details
Quarter 2017 Financial Results
Clinical trial approval by the FDA for wholly-owned UCART123 in AML &
BPDCN patients at Weill Cornell and MD Anderson
clearance granted by the FDA to Servier and Pfizer related to the Phase
I clinical trials of UCART19 in ALL patients
Considering the IPO of Calyxt, Cellectis' plant sciences subsidiary
position of $277 million1
( 259 million) as of March 31, 2017
NEW YORK--(BUSINESS WIRE)--May 9, 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 March 31, 2017.
RECENT CORPORATE HIGHLIGHTS
Cellectis - Therapeutics
UCART123 - Cellectis' most advanced, wholly controlled TALEN
gene-edited product candidate
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
Completion of 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
The FDA has granted Pfizer and Servier with Investigational New Drug
(IND) clearance to proceed in the U.S. with Phase I clinical
development of UCART19 to treat patients with relapsed/refractory
acute lymphoblastic leukemia.
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.
Scientific Conferences
Data on both wholly-controlled Cellectis programs and Pfizer/Cellectis
collaboration programs have been presented at the American Association
for Cancer Research (AACR) Annual Meeting:
UCART22: An allogeneic adoptive immunotherapy for leukemia
targeting CD22 with CAR T-cells
Allogeneic EGFRvIII Chimeric Antigen Receptor T-cells for
treatment of glioblastoma
Differential modulation of the PD-1 pathway impacts the anti-tumor
activity of CAR T-cells
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 Inc. - Cellectis' plant science subsidiary
In April 2017, Cellectis announced that it is exploring the
possibility of an initial public offering (IPO) of a minority interest
in its plant sciences business, Calyxt.
New Technology Framework Agreement with Plant Bioscience Limited
pursuant to which Calyxt received an option to obtain exclusive
license to new crops traits.
Former Cargill executive Manoj Sahoo joined Calyxt as the Company's
Chief Commercial Officer. As part of Calyxt's executive team Mr. Sahoo
is building a commercial partnership network and executing a
go-to-market plan for Calyxt. Mr. Sahoo is joining Calyxt from
Cargill, where he worked in the Food Ingredients and Bio-industrial
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").
First quarter 2017 Financial Results
Cash: As of March 31, 2017 Cellectis had 258.5 million in total
cash, cash equivalents and current financial assets compared to 276.2
million as of December 31, 2016. This decrease of 17.7 million reflects
(i) net cash flows used by operating activities of 15.3 million, (ii)
capital expenditures of 0.5 million and (iii) the unrealized negative
translation effect of exchange rate fluctuations on our U.S. dollar
cash, cash equivalents and current financial assets of 1.9 million.
Cellectis expects that its cash, cash equivalents and current financial
assets of 258.5 million as of March 31, 2017 will be sufficient to fund
its current operations to 2019.
Revenues and Other Income: During the quarters ended March 31,
2016 and 2017, we recorded 9.5 million and 9.7 million, respectively,
in revenues and other income. This increase primarily reflects (i) an
increase of 0.8 million in research tax credit, (ii) a decrease of 0.4
million in collaboration revenues, due primarily to a decrease of 1.4
million in upfront recognition and a decrease of 0.3 million in R&D
costs reimbursement, been partially offset by an increase of 1.3
million in supply agreements with Servier, and (iii) a decrease in
revenue from licenses of 0.2 million.
Total Operating Expenses: Total operating expenses for the first
quarter of 2017 were 28.2 million, compared to 29.9 million for the
first quarter of 2016. The non-cash stock-based compensation expenses
included in these amounts were 12.8 million and 13.4 million,
R&D Expenses: For the quarters ended March 31, 2016 and 2017,
research and development expenses decreased by 0.5 million from 18.9
million in 2016 to 18.4 million in 2017. Personnel expenses decreased
by 2.1 million from 11.9 million in 2016 to 9.8 million in 2017,
primarily due to a 1.7 million decrease in social charges on stock
option grants and a 0.5 million decrease in non-cash stock based
compensation expense, partly offset by a 0.1 million increase in wages