Full Press Release Details
Reports Financial Results for First Quarter 2019
Started construction of in-house manufacturing facilities IMPACT and
approved IND for UCARTCS1A product candidate in Multiple Myeloma
Published novel manufacturing methods to improve allogeneic CAR T-cell
of $425 million as of March 31, 2019
NEW YORK--(BUSINESS WIRE)--May 7, 2019--Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS; Nasdaq:
CLLS), a clinical stage biopharmaceutical company focused on developing
immunotherapies based on allogeneic gene-edited CAR T-cells (UCART),
today announced its results for the three-month period ended March 31,
"We have been executing against our 2019 plans, securing premises for
our in-house manufacturing facilities in the United States and in France
as well as receiving IND approval by the FDA for UCARTCS1A, our fourth
UCART product candidate," said Dr. Andr Choulika, Chairman and CEO of
Cellectis. "This year, Cellectis is planning to enroll patients in three
separate Phase 1 clinical trials covering three major hematologic
diseases, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and
Multiple Myeloma, with our proprietary allogeneic CAR T-cell product
candidates. In 2019, Cellectis and its partners will continue to extend
their first-mover advantage in the field of gene editing and allogeneic,
off-the-shelf CAR-T, with the goal of accelerating our ability to bring
our pioneering cell therapies to patients."
Q1 Corporate Highlights
Scientific Publication
In February 2019, we announced the publication of a study in The
Journal of Biological Chemistry, identifying Granulocyte Macrophage
Colony Stimulating Factor (GMCSF) secreted by Chimeric Antigen Receptor
(CAR) T-cells as a key factor promoting cytokine release syndrome (CRS).
The report leverages these findings to elaborate an innovative
engineering strategy that potentially paves the way for developing safer
This publication was significant because Cellectis' engineering strategy
could circumvent toxic side effects such as CRS and neurotoxicity,
thereby aiming to the development of safer, yet equally potent, UCART
product candidates in an effort to improve patients' quality of life
In March 2019, we entered into a lease agreement for an 82,000 square
foot commercial-scale manufacturing facility, called IMPACT, which
stands for "Innovative Manufacturing Plant for Allogeneic Cellular
Therapies". This new site, located in Raleigh, North Carolina, is being
designed to provide GMP manufacturing for clinical supplies and
commercial manufacturing upon potential regulatory approval. The
facility is planned to be operational by 2021.
In addition to IMPACT, Cellectis started building a 14,000 square foot
manufacturing facility in Paris, France, named SMART, which stands for
"Starting Material Realization for CAR-T products". This facility is
designed to produce Cellectis' critical starting material supplies for
UCART clinical studies and commercial products, and when combined with
IMPACT, will allow Cellectis to gain autonomy in its manufacturing
operations and consolidate its competitive leadership in the
In April 2019, Cellectis announced that the U.S. Food and Drug
Administration (FDA) approved the Company's Investigational New Drug
(IND) application to initiate a Phase 1 clinical trial with UCARTCS1A in
Multiple Myeloma (MM). Cellectis is the sponsor of the UCARTCS1A
At the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting,
Cellectis presented data from its Universal CAR T-cell programs in an
oral presentation and poster session.
The oral presentation presented data regarding the potential of
UCARTCS1A as a treatment approach for patients with Multiple Myeloma,
and followed the recent clearance of the UCARTCS1A IND by the FDA. The
poster presentation showcased Cellectis' allogeneic CAR T-cell
manufacturing expertise, with a focus on a novel, straightforward and
efficient strategy to generate Universal CAR T-cells. This exemplifies
opportunities for Cellectis' cutting-edge gene-editing and cell
engineering capabilities to be leveraged to improve key features of our
Further presentations were given by Julianne Smith, Ph.D., Vice
President of Translational Sciences and Philippe Duchateau, Ph.D., Chief
Scientific Officer at Cellectis. Dr. Smith participated in a corporate
review session at the Gene Editing Workshop prior to the official start
of the conference, while also presenting a talk entitled "Allogeneic
Gene-Edited CAR T-Cells: From Preclinical to Clinical Proof of Concept"
during the Scientific Symposium "Towards the Holy Grail of Cancer Gene
Therapies: Universal Cells, Targeted Vectors and Solid Tumor CART
Efficacy". Dr. Duchateau participated in the Scientific Symposium
"Innovation in First Time in Human Study Clinical Studies" with a
presentation titled "Universal Gene-Edited CAR T-Cell Immunotherapy".
In April 2019, at ASGCT Annual Meeting, we presented a novel method of
manufacturing ultrapure TCR-negative allogeneic CAR T-cells. With
transient expression of an anti-CD3 CAR in addition to the stably
expressed "therapeutic CAR" in the donor T-cells, we programed the cells
to self-eliminate the TCR+ cell population and obtained an ultrapure
TCR-negative population (99%-99.9%) at the end of CAR-T production. The
fitness of the produced cells was not affected by the transient
expression of the anti-CD3 CAR, nor did we see a significant impact in
the CAR T-cell growth rate, T-cell differentiation or exhaustion level
as compared to the non-CD3 CAR counterpart.
Both in vitro and in vivo T-cell killing assay results suggest that the
CD3-CAR treatment did not affect the CAR T-cell killing function.
This novel procedure has the potential to remove a tedious purification
step in TCR-negative CAR T-cell manufacturing.
The interim condensed consolidated financial statements of Cellectis,
which consolidate the results of Calyxt, Inc. of which Cellectis is a
69.5% stockholder, have been prepared in accordance with International
Financial Reporting Standards, or IFRS, as issued by the International
Accounting Standards Board ("GAAP").
We present certain financial metrics broken out between our two
reportable segments - Therapeutics and Plants - in the appendices of
this Q1 2019 financial results press release.
First quarter 2019 Financial Results
Cash: As of March 31, 2019, Cellectis, including Calyxt had $425
million in consolidated cash, cash equivalents, current financial assets
and restricted cash of which $340 million are attributable to Cellectis