Cellectis Reports First Quarter 2016 Financial Results

NEW YORK–(BUSINESS WIRE)– class= »bwalignl »>
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 André 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
  functions.
• 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 TCRα/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
  Science.
• 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.

Financial Results

As previously announced, commencing with this report of first quarter
results Cellectis will now publish quarter-over-quarter comparative
figures.

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
a basic and diluted basis), respectively. Adjusted net loss attributable
to shareholders of Cellectis for the first quarter of 2016 was €16.1
million (€0.46 per share on both a basic and a diluted basis) compared
to adjusted net income attributable to shareholders of Cellectis of €7.0
million (€0.22 per share on both a basic and a diluted basis), for the
first quarter of 2015. Adjusted net income (loss) attributable to
shareholders of Cellectis for the first quarter of 2016 and 2015
excludes a non-cash stock-based compensation expense of €13.4 million
and €0.8 million, respectively. Please see « Note Regarding Use of
Non-GAAP Financial Measures » for a reconciliation of GAAP net income to
adjusted net income.

Financial Guidance: Cellectis expects that its cash, cash
equivalents and Current financial assets of €276.5 million as of March
31, 2016 will be sufficient to fund its current operations through 2018.

___________________

(1) Cellectis reclassified certain expenses related to the year ended
December 31, 2015 from SG&A expenses to R&D expenses in the fourth
quarter of 2015. This allocation change is effective starting in 2015,
and is due to the increased level of efforts towards our R&D activities
in order to develop product candidates and work toward clinical phases.
Starting in 2015, we classify personnel and other costs related to
information technology, human resources, business development, legal,
intellectual property and general management in Research and development
expense based on the time that employees spent contributing to research
and development activities versus general and administrative activities.
We approved the allocation in the Q4 2015 and assess the performance of
the consolidated company based on this new classification.

Note Regarding Use of Non-GAAP Financial Measures

Cellectis S.A. presents Adjusted Net Income (Loss) attributable to
shareholders of Cellectis in this press release. Adjusted Net 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
Net 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 Net 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 industries which have similar Stock-based compensations, may
address the impact of Non-cash stock-based compensation expense
differently; and (b) other companies may report Adjusted Net 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 Net Income (Loss) attributable to shareholders of
Cellectis alongside our other 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 16 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 NYSE 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.

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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160511006474/en/