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    Cellectis Reports 2nd Quarter and First Half Year 2016 Financial Results

    Investing News Network
    Sep. 08, 2016 03:04PM PST
    Life Science Investing 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 June 30, 2016 and for the six-month period ended June 30, 2016.

    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 June 30, 2016 and for the six-month
    period ended June 30, 2016.
    Recent Corporate Highlights
    Cellectis

    • A Phase I study of UCART19 in pediatric acute B lymphoblastic leukemia
      (B-ALL) was initiated at the University College of London (UCL), with
      the first dose administered to a patient in June 2016. This UCART19
      clinical trial is sponsored by Servier in close collaboration with
      Pfizer.
    • Cellectis employees presented important scientific presentations:
      • An intrinsic safeguard Chimeric Antigen Receptor architecture for
        T-cell immunotherapy, presented by Julien Valton at ASCO, Chicago;
      • Allogeneic TCRα/CD38 double knockout T-cells bearing an anti-CD38
        Chimeric Antigen Receptor (CAR): an improved immunotherapy for the
        treatment of T-cell acute lymphoblastic leukemia (T-ALL) and
        multiple myeloma (MM), presented by Mathilde Dusseaux at EHA,
        Copenhagen, Denmark.
    • The MIT Technology Review has named the Company on its Annual
      List of 50 Smartest Companies
      for the second year in a row.
    • Cellectis has been selected as a 2016 World
      Economic Forum Technology Pioneer
      , a credential that is awarded
      annually to the most innovative and impactful companies developing new
      technologies around the world.

    1 Euro-US Dollar exchange rate as of June 30, 2016: 1.1102
    2
    Euro-US Dollar average exchange rate for the 2nd quarter
    2016: 1.1293
    3 See the section related to the
    reconciliation of gaap to non-gaap net income. GAAP Net Loss
    attributable to shareholders amounts to $7 million (€6 million) in the 2nd
    quarter of 2016
    Calyxt – Cellectis’ plant science subsidiary

    • Appointment of former Monsanto Corporation executive Federico A.
      Tripodi to the role of Chief Executive Officer, a key hire for the
      execution of the commercial business plan and market launch of lead
      programs.
    • Completed the expansion of its high-oleic / no-trans-fat (HO) soybean
      variety in Argentina, as part of its counter-season seed production.
      Thirty tons of HO soybean seeds have been shipped to production sites
      in the United States for further expansion, in preparation for an
      initial commercial launch expected in 2018.
    • Calyxt hosted an R&D Day in New York City on May 26. Speakers reviewed
      advancements made in the plant science community with a focus on
      Calyxt’s plant engineering platform. Additionally, management provided
      an overview of Calyxt’s crop programs.

    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 (“GAAP”).
    Second Quarter 2016 Financial Results
    Cash: As of June 30, 2016 Cellectis had €269.7 million in total
    cash, cash equivalents and current financial assets compared to €276.5
    million as of March 31, 2016. This decrease of €6.8 million notably
    reflects (i) the net cash flows used in operating activities of €7.6
    million and (ii) fixed assets expenditure of €2.4 million. The change
    was also attributable to the unrealized positive translation effect of
    exchange rate fluctuations on our U.S. dollar cash, cash equivalents and
    current financial assets of €5.8 million.
    Revenues and Other Income: During the quarters ended June 30,
    2015 and 2016, we recorded €8.0 million and €18.1 million, respectively,
    in revenues and other income. This is mainly due to the increase of (i)
    €8.6 million in collaboration revenues, notably due to the achievement
    of two milestones under our collaboration agreement with Servier and
    (ii) €1.5 million in research tax credit.
    Total Operating Expenses and Other Operating Income: Total
    operating expenses and other operating income for the second quarter of
    2016 were €28.2 million, compared to €20.1 million for the second
    quarter of 2015. The non-cash stock-based compensation expenses included
    in these amounts were €14.4 million and €7.1 million, respectively.
    R&D Expenses: For the quarters ended June 30, 2015 and 2016,
    research and development expenses increased by €6.7 million from €12.8
    million in 2015 to €19.5 million in 2016.Personnel expenses increased by
    €2.4 million from €9.3 million in 2015 to €11.6 million in 2016, notably
    due to a €0.5 million increase in wages and salaries, and a €4.5 million
    increase in non-cash stock based compensation expense, partly offset by
    a €2.6 million decrease in social charges on stock options and free
    share grants. Purchases and external expenses increased by €4.3 million
    from €3.2 million in 2015 to €7.5 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 quarters ended June 30, 2015 and
    2016, we recorded €6.9 million and €8.6 million, respectively, of
    selling, general and administrative expenses. The increase of €1.7
    million primarily reflects (i) an increase of €1.9 million in personnel
    expenses from €4.6 million to €6.5 million, attributable, among other
    things, to an increase of €2.7 million of non-cash stock-based
    compensation expense, partly offset by a decrease of €0.9 million of
    social charges on stock options and free share grants, and (ii) a
    decrease of €0.3 million in purchases and external expenses.
    Financial Gain (Loss): The financial loss was €10.0 million for
    the second quarter of 2015 compared with a financial gain of €3.8
    million for the second 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 Income (Loss) Attributable to Shareholders of Cellectis:
    During the three months ended June 30, 2015 and 2016, we recorded a net
    loss of €22.2 million (or €0.63 per share on both a basic and a diluted
    basis) and net loss of €6.3 million (or €0.18 per share on both a basic
    and a diluted basis), respectively. Adjusted income attributable to
    shareholders of Cellectis for the second quarter of 2016 was €8.1
    million (€0.23 per share on both a basic and a diluted basis) compared
    to Adjusted loss attributable to shareholders of Cellectis of €15.0
    million (€0.43 per share on both a basic and a diluted basis), for the
    second quarter of 2015. Adjusted income (loss) attributable to
    shareholders of Cellectis for the second quarter of 2016 and 2015
    excludes non-cash stock-based compensation expense of €14.4 million and
    €7.2 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.
    First Half Year 2016 Financial Results
    Cash: As of June 30, 2016 Cellectis had €269.7 million in total
    cash, cash equivalents and current financial assets compared to €314.2
    million as of December 31, 2015. This decrease of €44.5 million was
    primarily driven by (i) €27.2 million of cash used in operating
    activities in connection with the initiation of industrial Good
    Manufacturing Practice (“GMP”) production of UCART123, increased
    expenses in materials required of GMP production and a payment of €7.2
    million of value added taxes related to proceeds received in the fourth
    quarter of 2015 from Servier, and (ii) €10.8 million of cash used in
    investment activities, primarily through Calyxt’s land acquisition and
    greenhouse construction in an aggregate amount of €8.9 million. The
    decrease was also partially attributable to the negative unrealized
    translation effect of exchange rate fluctuations on our U.S. dollar
    cash, cash equivalents and current financial assets accounts of €5.8
    million.
    Cellectis expects that its cash, cash equivalents and Current financial
    assets of €269.7 million as of June 30, 2016 will be sufficient to fund
    its current operations through the end of 2018.
    Revenues and Other Income: During the six months ended June 30,
    2015 and 2016, we recorded €17.2 million and €27.6 million,
    respectively, in revenues and other income. This is mainly due to the
    increase of (i) €7.1 million in collaboration revenues notably due to
    the achievement of two milestones under our collaboration agreement with
    Servier and (ii) €3.4 million in research tax credit.
    Total Operating Expenses and Other Operating Income: Total
    operating expenses and other operating income for the first half of 2016
    were €58.1 million, compared to €32.9 million for the first half of
    2015. The non-cash stock-based compensation expenses included in these
    amounts were €27.8 million and €8.0 million, respectively.
    R&D Expenses: For the six months ended June 30, 2015 and
    2016, research and development expenses increased by €18.2 million from
    €20.2 million in 2015 to €38.4 million in 2016. Personnel expenses
    increased by €9.5 million from €13.9 million in 2015 to €23.5 million in
    2016, notably due to a€1.4 million increase in wages and salaries, and a
    €11.6 million increase in non-cash stock based compensation expense,
    partly offset by a €3.5 million decrease in social charges on stock
    options and free share grants. Purchases and external expenses increased
    by €8.5 million from €5.7 million in 2015 to €14.2 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 six months ended June 30, 2015 and
    2016, we recorded €12.2 million and €19.2 million, respectively, of
    selling, general and administrative expenses. The increase of
    €6.9 million primarily reflects (i) an increase of €6.5 million in
    personnel expenses from €8.3 million to €14.8 million, attributable,
    among other things, to an increase of €8.2 million of non-cash
    stock-based compensation expense, partly offset by a decrease of
    €2.0 million of social charges on stock options and free share grants,
    and (ii) an increase of €0.4 million in purchases and external expenses.
    Financial Gain (Loss): The financial loss was €0.2 million for
    the first half year of 2015 compared with financial loss of €5.3 million
    for the first half year 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 Income (Loss) Attributable to Shareholders of Cellectis:
    During the six months ended June 30, 2015 and 2016, we recorded a net
    loss of €16.0 million (or €0.48 per share on both a basic and a diluted
    basis) and a net loss of €35.7 million (or €1.01 per share on both a
    basic and diluted basis), respectively. Adjusted loss attributable to
    shareholders of Cellectis for the first half of 2016 was €7.9 million
    (€0.22 per share on both a basic and a diluted basis) compared to
    Adjusted income attributable to shareholders of Cellectis of €8.0
    million (€0.24 per share on both a basic and a diluted basis), for the
    first half of 2015. Adjusted loss attributable to shareholders of
    Cellectis for the first half of 2016 and 2015 excludes a non-cash
    stock-based compensation expense of €27.8 million and €8.0 million,
    respectively. Please see “Note Regarding Use of Non-GAAP Financial
    Measures” for a reconciliation of GAAP net income (loss) attributable to
    shareholders of Cellectis to Adjusted income (loss) attributable to
    shareholders of Cellectis.

    CELLECTIS S.A.

    STATEMENT OF CONSOLIDATED FINANCIAL POSITION

    (unaudited)

    (€ in thousands, except per share data)

    As of
    December 31, 2015June 30, 2016
    ASSETS
    Non-current assets
    Intangible assets9561 268
    Property, plant, and equipment5 04315 196
    Other non-current financial assets845749
    Total non-current assets6 84417 213
    Current assets
    Inventories and accumulated costs on orders in process158125
    Trade receivables6 03513 816
    Subsidies receivables9 10213 324
    Other current assets4 6858 189
    Cash and cash equivalent and Current financial assets314 238269 719
    Total current assets334 218305 173
    TOTAL ASSETS341 062322 387
    LIABILITIES
    Shareholders’ equity
    Share capital1 7591 767
    Premiums related to the share capital420 682448 388
    Treasury share reserve(184)(239)
    Currency translation adjustment(1 631)(1 510)
    Retained earnings(137 188)(157 828)
    Net income (loss)(20 544)(35 719)
    Total shareholders’ equity – Group Share262 894254 859
    Non-controlling interests7251 166
    Total shareholders’ equity263 619256 024
    Non-current liabilities
    Non-current financial liabilities6638
    Non-current provisions437565
    Total non-current liabilities503603
    Current liabilities
    Current financial liabilities1 9212 173
    Trade payables6 61111 324
    Deferred revenues and deferred income54 75844 620
    Current provisions953847
    Other current liabilities12 6976 796
    Total current liabilities76 94065 760
    TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY341 062322 387

    CELLECTIS S.A.

    STATEMENT OF CONSOLIDATED OPERATIONS – SECOND QUARTER

    (unaudited)

    (€ in thousands, except per share data)

    For the three-month period
    ended June 30,
    20152016
    Revenues and other income
    Revenues7 32815 823
    Other income6762 317
    Total revenues and other income8 00418 140
    Operating expenses and other operating income (expenses)
    Royalty expenses(392)(291)
    Research and development expenses (1)(12 782)(19 526)
    Selling, general and administrative expenses (1)(6 865)(8 600)
    Other operating income166264
    Redundancy plan280
    Other operating expenses(285)(8)
    Total operating expenses and other operating income (expenses)(20 130)(28 158)
    Operating income (loss)(12 126)(10 018)
    Financial gain (loss)(10 039)3 763
    Net income (loss)(22 166)(6 255)
    Attributable to shareholders of Cellectis(22 166)(6 255)
    Attributable to non-controlling interests––
    Basic earnings attributable to shareholders of Cellectis per
    share (€/share)
    (0,63)(0,18)
    Diluted earnings attributable to shareholders of Cellectis per
    share (€/share)
    (0,63)(0,18)

    __________________
    (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 reclassification 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 reclassification in Q4 2015 and assess the performance
    of the consolidated company based on this new classification.

    CELLECTIS S.A.

    STATEMENT OF CONSOLIDATED OPERATIONS – FIRST HALF-YEAR

    (unaudited)

    (€ in thousands, except per share data)

    For the six-month period
    ended June 30,
    20152016
    Revenues and other income
    Revenues15 75622 801
    Other income1 4674 838
    Total revenues and other income17 22327 639
    Operating expenses and other operating income (expenses)
    Royalty expenses(819)(723)
    Research and development expenses (1)(20 218)(38 396)
    Selling, general and administrative expenses (1)(12 225)(19 127)
    Other operating income516386
    Redundancy plan2351
    Other operating expenses(397)(206)
    Total operating expenses and other operating income (expenses)(32 907)(58 066)
    Operating income (loss)(15 684)(30 427)
    Financial gain (loss)(166)(5 292)
    Net income (loss)(15 850)(35 719)
    Attributable to shareholders of Cellectis(16 020)(35 719)
    Attributable to non-controlling interests171–
    Basic earnings attributable to shareholders of Cellectis per
    share (€/share)
    (0,48)(1,01)
    Diluted earnings attributable to shareholders of Cellectis per
    share (€/share)
    (0,48)(1,01)

    ___________________
    (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 reclassification 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 reclassification in 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 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.

    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME – Second quarter

    (unaudited)

    (€ in thousands, except per share data)

    For the three-month period
    ended June 30,
    20152016
    Net Income (Loss) attributable to shareholders of Cellectis(22 166)(6 255)
    Adjustment:
    Non-cash stock-based compensation expense
    7 17814 383
    Adjusted Income (Loss) attributable to shareholders of Cellectis(14 988)8 128
    Basic Adjusted Income (Loss) attributable to shareholders of
    Cellectis (€/share)
    (0,43)0,23
    Weighted average number of outstanding shares, basic (units)35 043 25135 295 817
    Diluted Adjusted Income (Loss) attributable to shareholders of
    Cellectis (€/share)
    (0,43)0,23
    Weighted average number of outstanding shares, diluted (units)35 211 73735 472 312

    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME – First half-year

    (unaudited)

    (€ in thousands, except per share data)

    For the six-month period
    ended June 30,
    20152016
    Net Income (Loss) attributable to shareholders of Cellectis(16 020)(35 719)
    Adjustment:
    Non-cash stock-based compensation expense
    8 01727 797
    Adjusted Income (Loss) attributable to shareholders of Cellectis(8 003)(7 922)
    Basic Adjusted Income (Loss) attributable to shareholders of
    Cellectis (€/share)
    (0,24)(0,22)
    Weighted average number of outstanding shares, basic (units)33 181 53535 245 549
    Diluted Adjusted Income (Loss) attributable to shareholders of
    Cellectis (€/share)
    (0,24)(0,22)
    Weighted average number of outstanding shares, diluted (units)33 505 00135 622 858

    As a foreign private issuer, we are not required under the Exchange Act
    to file periodic reports and financial statements with the SEC as
    frequently or as promptly as United States companies whose securities
    are registered under the Exchange Act. Notwithstanding the foregoing, we
    currently provide quarterly interim consolidated financial data to the
    SEC, and commencing with our first quarter interim report for the 2017
    fiscal year, we intend to file our periodic reports within the deadlines
    applicable to domestic reporting companies.
    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.

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