Full Press Release Details
Reports First Quarter 2016 Financial Results
Initiated UCART123 GMP production concept
strategic supply of key materials for GMP manufacturing
cash position of $315 million ( 276 million) as of March, 31 2016
NEW YORK--(BUSINESS WIRE)--May 11, 2016--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, 2016.
"We are excited to monitor the results presented by Great Ormond Street
Hospital - University College of London describing clinical application
of allogeneic, off-the-shelf CAR T-cells in young ALL patients with high
medical need who exhausted all other treatment options. We are looking
forward to seeing more data updates from our partners and bringing our
CAR T-cell programs into the clinic, starting with UCART123 for AML
patients," said Andr Choulika, CEO, Cellectis.
Recent Corporate Highlights
New agreement with CELLforCURE for the cGMP manufacturing of
clinical batches of UCART123, Cellectis' lead product candidate, and
for the implementation of cGMP manufacturing processes designed and
developed by Cellectis.
Supply and license agreement with Takara Bio Inc. for recombinant
human fibronectin fragment RetroNectin to support Cellectis'
manufacturing processes and production capabilities.
Publication in Scientific Reports, part of Nature Publishing Group,
describing the design and development of a new CAR architecture with
an integrated switch-on system that allows control over CAR T-cell
Research collaboration and license agreement with MabQuest SA for the
development of a new class of anti PD-1 monoclonal antibodies.
Cellectis gave a presentation at the Cowen and Company 36th Annual
Health Care Conference on March 9, 2016 in Boston, MA.
Scientific presentations at AACR, New Orleans:
Allogeneic TCR /CS1 double knockout T-cell bearing an anti-CS1
chimeric antigen receptor: an improved immunotherapy approach for the
treatment of Multiple Myeloma, presented by Roman Galetto, Cellectis.
Improved safety by a non-lethal switch to control CAR activity at the
T-cell surface membrane, presented by Laurent Poirot, Cellectis.
Appointment of Dr. Loan Hoang-Sayag to the role of Chief Medical
Officer. Dr. Hoang-Sayag joined Cellectis from Quintiles
Transnational, where she was most recently Senior Director of Medical
Calyxt, Cellectis' plant science subsidiary, has purchased a 10-acre
parcel in the St. Paul suburb of Roseville, MN, to build a new
greenhouse and company headquarter.
As previously announced, commencing with this report of first quarter
results Cellectis will now publish quarter-over-quarter comparative
Cellectis' consolidated financial statements have been prepared in
accordance with International Financial Reporting Standards, or IFRS, as
issued by the International Accounting Standards Board ("GAAP").
First Quarter 2016 Financial Results
Cash: As of March 31, 2016 Cellectis had 276.5 million in total
cash, cash equivalents and current financial assets compared to 314.2
million as of December 31, 2015. This notably reflects (i) the
initiation of industrial GMP UCART123 production, (ii) increased
expenses in GMP materials (iii) payment of 7.2 million of Value Added
Taxes related to the proceeds received in the fourth quarter of 2015
from Servier and (iv) Calyxt's acquisition of a 10-acre parcel for 5.2
million. The change was also attributable to the unrealized translation
effect of exchange rate fluctuations on our U.S. dollar cash and cash
equivalent accounts.
Revenues and Other Income: During the three months ended March
31, 2015 and 2016, we recorded 9.2 million and 9.5 million,
respectively, in revenues and other income.
Total Operating Expenses and Other Operating Income: Total
operating expenses and other operating income for the first quarter of
2016 were 29.9 million, compared to 12.8 million for the first quarter
of 2015. The non-cash stock-based compensation expenses included in
these amounts were 13.4 million and 0.8 million, respectively.
R&D Expenses: For the three months ended March 31, 2015 and
2016, research and development expenses increased by 11.4 million from
7.4 million in 2015 to 18.9 million in 2016. Personnel expenses
increased by 7.2 million from 4.7 million in 2015 to 11.9 million in
2016, notably due to a 1.0 million increase in wages and salaries, and
a 7.2 million increase in non-cash stock based compensation expense,
partly offset by a 1.0 million decrease in social charges on stock
option and free shares grants. Purchases and external expenses increased
by 4.2 million from 2.4 million in 2015 to 6.6 million in 2016, due
to increased expenses related to innovation and platform development,
including payments to third parties participating in product
development, purchases of biological raw materials and expenses
associated with the use of laboratories and other facilities.
SG&A Expenses: During the three months ended March 31, 2015
and 2016, we recorded 5.4 million and 10.5 million, respectively, of
selling, general and administrative expenses. The increase of 5.2
million primarily reflects (i) an increase of 4.5 million in personnel
expenses from 3.7 million to 8.3 million, attributable, among other
things, to an increase of 5.4 million of non-cash stock-based
compensation expense, partly offset by a decrease of 1.1 million of
social charges on stock options and free share grants, and (ii) an
increase of 0.8 million in purchases and external expenses.
Financial gain (loss): The financial gain was 9.9 million for
the first quarter of 2015 compared with financial loss of 9.1 million
for the first quarter of 2016, which does not reflect actions undertaken
to mitigate the impact of currency exchange rate fluctuations that were
adopted at the end of the first quarter of 2016. The change in financial
result was primarily attributable to the effect of exchange rate
fluctuations on our U.S. dollar cash and cash equivalent accounts.
Net Loss Attributable to Shareholders of Cellectis: During the
three months ended March 31, 2015 and 2016, we recorded a net income of
6.3 million (or 0.20 per share on a basic basis and 0.19 per share on
a diluted basis) and a loss of 29.5 million (or 0.84 per share on both