Cellectis Reports 1st Quarter 2017 Financial Results

NEW YORK–(BUSINESS WIRE)– 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
  Cancer Medicine.
• Completion of cGMP manufacturing runs of UCART123 at large scale, to
  provide doses for initiating planned Phase I clinical trials in AML
  and BPDCN patients.

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
  Enterprise

Financial Results

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,
respectively.

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
and salaries. Purchases and external expenses increased by €1.5 million
from €6.6 million in 2016 to €8.2 million in 2017, mainly due to
increased expenses related to UCART123 and the development of other
product candidates, including payments to third parties, purchases of
biological materials and expenses associated with the use of
laboratories and other facilities.

SG&A Expenses: During the quarters ended March 31, 2016 and
2017, we recorded €10.5 million and €9.1 million, respectively, of
selling, general and administrative expenses. The increase of €1.4
million primarily reflects (i) a decrease of €1.1 million in personnel
expenses from €8.3 million to €7.2 million, attributable, to a decrease
of €1.5 million of social charges on stock options grants and a decrease
of €0.1 million of non-cash stock-based compensation expense, partly
offset by a €0.5 million increase in wages and salaries, and (ii) a
decrease of €0.4 million in purchases and external expenses.

Financial Gain (Loss): The financial loss was €9.1 million for
the first quarter of 2016 compared with an almost nil financial result
for the first quarter of 2017. The change in financial result was
primarily attributable to a decrease in net foreign exchange loss of
€7.6 million due to the effect of exchange rate fluctuations on our USD
cash and cash equivalent accounts, an increase of €1.0 million in fair
value adjustment income on our foreign exchange derivatives and current
financial assets and a €0.2 million net gain realized on the
repositioning of foreign exchange derivative instruments.

Net Income (Loss) Attributable to Shareholders of Cellectis:
During the quarters ended March 31, 2016 and 2017, we recorded a net
loss of €29.5 million (or €0.84 per share on both a basic and a diluted
basis) and a net loss of €18.6 million (or €0.53 per share on both a
basic and a diluted basis), respectively. Adjusted loss attributable to
shareholders of Cellectis for the first quarter of 2017 was €5.8 million
(€0.16 per share on both a basic and a diluted basis) compared to
adjusted income attributable to shareholders of Cellectis of €16.1
million (€0.46 per share on both a basic and a diluted basis), for the
first quarter of 2016. Adjusted income (loss) attributable to
shareholders of Cellectis excludes non-cash stock-based compensation
expense of €12.8 million and €13.4 million, respectively. Please see
« Note Regarding Use of Non-GAAP Financial Measures » for reconciliation
of GAAP net income (loss) attributable to shareholders of Cellectis to
Adjusted income (loss) attributable to shareholders of Cellectis.

Note Regarding Use of Non-GAAP Financial Measures

Cellectis S.A. presents Adjusted Income (Loss) attributable to
shareholders of Cellectis in this press release. Adjusted Income (Loss)
attributable to shareholders of Cellectis is not a measure calculated in
accordance with IFRS. We have included in this press release a
reconciliation of this figure to Net Income (Loss) attributable to
shareholders of Cellectis, the most directly comparable financial
measure calculated in accordance with IFRS. Because Adjusted Income
(Loss) attributable to shareholders of Cellectis excludes Non-cash
stock-based compensation expense—a non-cash expense, we believe that
this financial measure, when considered together with our IFRS financial
statements, can enhance an overall understanding of Cellectis’ financial
performance. Moreover, our management views the Company’s operations,
and manages its business, based, in part, on this financial measure. In
particular, we believe that the elimination of Non-cash stock-based
expenses from Net Income (Loss) attributable to shareholders of
Cellectis can provide a useful measure for period-to-period comparisons
of our core businesses. Our use of Adjusted Income (Loss) attributable
to shareholders of Cellectis has limitations as an analytical tool, and
you should not consider it in isolation or as a substitute for analysis
of our financial results as reported under IFRS. Some of these
limitations are: (a) other companies, including companies in our
industry which use similar stock-based compensation, may address the
impact of Non-cash stock-based compensation expense differently; and (b)
other companies may report Adjusted Income (Loss) attributable to
shareholders or similarly titled measures but calculate them
differently, which reduces their usefulness as a comparative measure.
Because of these and other limitations, you should consider Adjusted
Income (Loss) attributable to shareholders of Cellectis alongside our
IFRS financial results, including Net Income (Loss) attributable to
shareholders of Cellectis.

About Cellectis

Cellectis is a biopharmaceutical company focused on developing
immunotherapies based on gene edited CAR T-cells (UCART). The company’s
mission is to develop a new generation of cancer therapies based on
engineered T-cells. Cellectis capitalizes on its 17 years of expertise
in genome engineering – based on its flagship TALEN^® products
and meganucleases and pioneering electroporation PulseAgile technology –
to create a new generation of immunotherapies. CAR technologies are
designed to target surface antigens expressed on cells. Using its
life-science-focused, pioneering genome-engineering technologies,
Cellectis’ goal is to create innovative products in multiple fields and
with various target markets. Cellectis is listed on the Nasdaq market
(ticker: CLLS) and on the Alternext market (ticker: ALCLS). To find out
more about us, visit our website: www.cellectis.com

Talking about gene editing? We do it.
TALEN^® is a
registered trademark owned by the Cellectis Group.

This press release does not constitute an offer to sell or the
solicitation of an offer to buy securities, and shall not constitute an
offer, solicitation or sale in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of that jurisdiction.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain “forward – looking statements”
within the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements may be identified by words such as
“anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,”
“is designed to,” “may,” “might,” “plan,” “potential,” “predict,”
“objective,” “should,” or the negative of these and similar expressions
and include, but are not limited to, statements regarding the outlook
for Cellectis’ future business and financial performance.
Forward-looking statements are based on management’s current
expectations and assumptions, which are subject to inherent
uncertainties, risks and changes in circumstances, many of which are
beyond Cellectis’ control. Actual outcomes and results may differ
materially due to global political, economic, business, competitive,
market, regulatory and other factors and risks. Cellectis expressly
disclaims any obligation to update or revise any of these
forward-looking statements, whether because of future events, new
information, a change in its views or expectations, or otherwise.

¹ Translated only for convenience into U.S. dollars at an
exchange rate of €1.00=$1.0691, the daily reference rate reported by the
European Central Bank (“ECB”) as of March 31, 2017

Image may be NSFW.
Clik here to view.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170509006624/en/