Full Press Release Details
Reports Financial Results for Third Quarter and First Nine Months of 2017
lifted the clinical hold from both Phase 1 trials of UCART123 in acute
myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell
results of the first-in-human clinical trials of UCART19 will be
presented at the 59th American Society of Hematology (ASH) annual
on July 25, 2017 of the Nasdaq-listed IPO of Calyxt, a 79,8% owned
subsidiary of Cellectis - with $64.4 million in gross proceeds to
position of $304 million as of September 30, 2017
NEW YORK--(BUSINESS WIRE)--November 13, 2017--Regulatory News:
Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS -
Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on
developing immunotherapies based on gene-edited allogeneic CAR T-cells
(UCART), today announced its results for the three-month period ended
September 30, 2017 and for the nine-month period ended September 30,
Earnings Call Details
Cellectis will host an earnings call on November 14, 2017 at 8:30am
Eastern Time to discuss its financial results and provide a general
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: 11/28/17
Webcast URL (Archived for 6 months): http://cellectis.equisolvewebcast.com/q3-2017
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1 Cash position includes cash, cash
equivalent and current financial assets.
Third Quarter 2017 and Recent Highlights
Cellectis - Therapeutics
UCART123: Cellectis' TALEN gene-edited, allogeneic CAR T product
candidate in AML and BPDCN Patients
As of November 6, 2017, Cellectis announced that the U.S. Food and Drug
Administration (FDA) has lifted the clinical hold, previously announced
on September 4, 2017, on both Phase 1 trials of UCART123 product
candidate in acute myeloid leukemia (AML) and blastic plasmacytoid
dendritic cell neoplasm (BPDCN). In connection with the lifting of the
clinical hold, Cellectis agreed with the FDA to certain revisions to be
implemented in Phase 1 UCART123 protocols. Cellectis is currently
working with the investigators from Weill Cornell Medicine New York -
Presbyterian Hospital and MD Anderson Cancer Center to obtain approval
of the revised protocols from their respective institutional review
boards in order to resume patient enrollment.
UCART19: TALEN gene-edited, allogeneic CAR T product candidate in
ALL patients, exclusively licensed to Servier
Preliminary results of the first-in-human clinical trials of UCART19
will be presented at the 59th American Society of Hematology
annual meeting (the "ASH Annual Meeting") to be held from December 9 to
12, 2017 in Atlanta, GA. Results from the UCART19 clinical trial in
adult ALL patients will be presented orally by Reuben Benjamin,
principal investigator for the trial and consultant hematologist at
King's College Hospital, United Kingdom. Results from the UCART19
clinical trial in pediatric ALL patients will be presented during a
poster session by Waseem Qasim, principal investigator for the trial and
consultant in pediatric immunology and reader in cell and gene therapy
at Great Ormond Street Hospital for Children, United Kingdom.
UCARTCS1, UCART22 & UCART123
Three abstracts regarding other Company's off-the-shelf CAR T product
candidates have been accepted for presentation at the 59th
American Society of Hematology (ASH) Annual Meeting:
UCARTCS1: Universal SLAMF7-Specific CAR T-Cells As Treatment for
Multiple Myeloma (oral presentation)
UCART22: Pre-clinical Activity of Allogeneic Anti-CD22 CAR T-Cells
for the Treatment of B-cell Acute Lymphoblastic Leukemia (oral
UCART123 product candidate targeting Blastic Plasmacytoid Dendritic
Cell Neoplasm (poster presentation)
Corporate Governance
On October 4, 2017, Mathieu Simon M.D., Executive VP and Chief Operating
Officer, as been appointed as Interim Chief Medical Officer. In
accepting this position, Dr. Simon assumes the responsibilities of Loan
Hoang-Sayag, who left Cellectis to pursue other professional
opportunities. Effective on October 11, 2017, Dr. Simon also resigned
from his position as a member of the board of directors in order to
focus on his additional responsibilities as Interim Chief Medical
Calyxt, Inc. - Cellectis' plant science subsidiary
Calyxt's herbicide-tolerant wheat, its third wheat product candidate,
and improved oil composition canola, its first canola product candidate,
have advanced to Phase 1 of development. With these phase advancements,
Calyxt now has a total of nine product candidates in Phase 1 of
development or later across its five crops: soybeans, wheat, canola,
potatoes and alfalfa.
The first of Calyxt's two alfalfa product candidates has been designated
as a non-regulated article under the "Am I Regulated?" Process by
Biotechnology Regulatory Services of the Animal and Plant Health
Inspection Service (APHIS), an agency of the USDA. The improved quality
alfalfa is the sixth Calyxt product candidate to be confirmed as a
non-regulated article by the USDA including its high oleic soybean, high
oleic / low linolenic soybean, powdery mildew resistant wheat, cold
storable potatoes and reduced browning potatoes.
Initial Public Offering: On July 25, 2017, Calyxt
completed an initial public offering of its common stock, selling an
aggregate of 8,050,000 shares of common stock at a price of $8.00 per
share (including 1,050,000 shares of common stock pursuant to the
exercise by the underwriters of their option to purchase additional
shares). Calyxt received net proceeds of approximately $58.0 million,
after deducting underwriting discounts and commissions and offering
expenses. As part of the IPO, Cellectis purchased 2,500,000 shares of
common stock for a value of $20.0 million, which is included in the net
proceeds that Calyxt received. Calyxt used $5.7 million of the proceeds
to cover a portion of the outstanding obligations owed to Cellectis.