Full Press Release Details
Reports Financial Results for 2nd
Quarter and First Six Months 2017
AML patient treated with UCART123, our allogeneic CAR T product
candidate in the Phase I dose-escalation study arm; enrollment ongoing
clearance granted by the FDA to Servier and Pfizer related to the
Phase I clinical trials of UCART19 in ALL patients
of the Calyxt's Nasdaq IPO with $64.4 million in gross proceeds to
Calyxt on July 25, 2017
cash position of $272 million1
( 238 million) as of June 30, 2017
NEW YORK--(BUSINESS WIRE)--August 2, 2017--Regulatory News:
Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS), a clinical-stage
biopharmaceutical company focused on developing immunotherapies based on
gene-edited CAR T-cells (UCART), today announced its results for the
three-month period ended June 30, 2017 and for the six-month period
ended June 30, 2017.
____________________________
1 Translated only for convenience into U.S. dollars at an
exchange rate of 1.00=$1.1412, the daily reference rate reported by the
European Central Bank ("ECB") as of June 30, 2017.
Second Quarter 2017 and Recent Highlights
Cellectis - Therapeutics
UCART123: Cellectis' most advanced, wholly controlled TALEN
gene-edited, allogeneic CAR T product candidate
First patient administration of UCART123 product candidate - in Acute
Myeloid Leukemia (AML), marking the start of the Phase I dose
For AML patients, the Phase I clinical trial is being conducted at
Weill Cornell Medicine New York - Presbyterian Hospital, and led
by Gail J. Roboz, MD, Director of the Clinical and Translational
Leukemia Programs and Professor of Medicine.
For Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) patients,
the Phase I clinical trial is being conducted at MD Anderson
Cancer Center, and is led by Naveen Pemmaraju, MD, Assistant
Professor, and Hagop Kantarjian, MD, Professor and Department
Chair, Department of Leukemia, Division of Cancer Medicine.
UCART19: exclusively licensed to Servier
IND clearance obtained for Servier, in collaboration with Pfizer, to
proceed with UCART19 Phase I clinical trials in the U.S. in patients
with relapsed /refractory acute lymphoblastic leukemia (ALL).
UCART19 Phase I clinical trials in pediatric and adult ALL patients
are ongoing at University College London (UCL) and Kings College
London (KCL), in the UK, sponsored by Servier.
On-going manufacturing of UCART CS1, an allogeneic CAR T-cell product
candidate for Multiple Myeloma.
Signed a Development and Manufacturing Agreement on July 27, 2017 with
MolMed S.p.A for the development and manufacturing of UCAR T-cell
IP/ Patent portfolio
U.S. patent 8,921,332, which claims the use of chimeric restriction
endonucleases for directing chromosomal gene editing in cells by
homologous recombination (HR), initially issued on Dec. 30, 2014, was
upheld by the United States Patent and Trademark Office (USPTO) after
a reexamination initiated in October 2015.
Grant by the European Patent Office of patent No. EP3004337, covering
a method of using RNA-guided endonucleases, such as Cas9 or Cpf1 for
the genetic engineering of T-cells
Presentation of data on Cellectis' UCART product candidates at the
ASGCT 20th Annual Meeting in Washington, D.C., USA.
Presentations on Cellectis-controlled programs and Pfizer/Cellectis
collaboration programs at the 2017 American Association for Cancer
Research (AACR) Annual Meeting:
Wholly-controlled Program UCART22: An Allogeneic Adoptive
Immunotherapy for Leukemia Targeting CD22 with CAR T-cells;
Collaboration Programs:
Allogeneic EGFRvIII Chimeric Antigen Receptor T-cells for
Treatment of Glioblastoma and
Differential Modulation of the PD-1 Pathway Impacts the
Anti-Tumor Activity of CAR T- cells.
Company's founder, Chairman and CEO, Dr. Andr Choulika participated
at the 2017 Milken Institute Global Conference as a panelist for a
session titled, "Humankind vs. Cancer: The Scorecard" on Wednesday,
Corporate Governance
Cellectis Shareholders' General Meeting was held at the Company's head
office in Paris on June 26, 2017. At the meeting, more than 73% of
voting rights were exercised, and all resolutions recommended by the
board of directors, were adopted, including:
the appointment of two new directors to the board of directors,
Mr. Rainer Boehm and Mr. Herv Hoppenot; and
the renewal of the term of office of director of Mr. Laurent
Arthaud, Mr. Pierre Bastid and Mrs. Annick Schwebig.
Calyxt Inc. - Cellectis' plant science subsidiary
Calyxt closed its IPO with $64.4 million in gross proceeds to Calyxt
from the sale of approximately 8 million shares at $8 per share,
including the full exercise of the underwritter's overallotment option
and Cellectis' purchase of $20.0 million of shares in the IPO.
Calyxt's shares of common stock are traded on NASDAQ under the symbol
"CLXT". Cellectis owns approximately 79.9% of Calyxt's outstanding
shares of common stock.
Calyxt launched, under a services agreement with University of
Minnesota U.S. field trials for powdery mildew-resistant spring wheat
variety, representing its fourth gene-edited crop to undergo trials
Joseph B. Saluri was named as General Counsel and Executive Vice
President, Corporate Development. Mr. Saluri brings to Calyxt over 24
years of legal, business development, strategic planning and project
management experience in the global agri-business space.
Calyxt signed an agreement with a third-party for the sale and
leaseback of its Roseville, MN, greenhouse and warehouse facility and
construction of the remaining facility. The completion of the sale is
conditioned on Calyxt and the buyer entering into a new facility
construction agreement and a lease in respect of the property in the
forms contemplated by the sale agreement.