Cellect Biotechnology Ltd Provides Corporate Update and Reports Third Quarter 2017 Financial Results

Cellect Biotech today provided a corporate update and announced financial results for the third quarter ended September 30, 2017.

 
[22-November-2017]
 
 

TEL AVIV, Israel, Nov. 22, 2017 /PRNewswire/ -- Cellect Biotechnology (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of stem cells, today provided a corporate update and announced financial results for the third quarter ended September 30, 2017.

"We are very pleased with our accomplishments in the third quarter of 2017" said Dr. Shai Yarkoni, Chief Executive Officer; "As planned, the third quarter continues to show progress in Cellect's path to global leadership in the regenerative medicine arena. We were granted an important FDA Orphan Drug Designation Status for Cellect's ApoGraft™ for the prevention of acute and chronic GvHD which we believe will allow us to efficiently speed up the commercialization process of ApoGraft™ and with the view to the future, we have successfully completed a voluntary de-listing from the Tel-Aviv stock exchange and migrated to trade exclusively on the NASDAQ to maximize shareholders' value from our future endeavors. In this respect we have also successfully raised $4.3M gross during the third quarter of 2017, to finance our strategic business development activities. We remain confident of our progress and leadership position in the stem cell market."

Recent Corporate Highlights:

  • We reported positive results from a 20 patients trial at Tel-Aviv Ichilov Medical Center in which ApoGraft™ significantly improved stem cells derived from fat tissues. The significance of the findings opens ApoGraft™ up to be used by a much wider array of companies and medical centers worldwide developing stem cell based products and treatments. Of special importance are the aesthetic and orthopedic indications where fat-derived stem cells are the main raw material;
  • We nominated Dr. Ronit Bakimer-Kleiner as Chief Development Officer replacing Dr. Yaron Pereg;
  • Company's CEO, Dr. Shai Yarkoni, was chosen to present Cellect technology and recent advancements at the Bio-Europe 2017 conference in Berlin (https://ebdgroup.knect365.com/bioeurope/about-bio-europe) alongside other selected industry leaders including Andrew Yost, VP, Corporate Development, REGENXBIO Inc., Gabriele Proetzel, Director, Regenerative Medicine, Takeda and Sharon Brownlow, Head of Collaborations - Manufacturing Centre, The Cell and Gene Therapy Catapult. The panel was moderated by the Founder of Alliance of Regenerative Medicine (ARM);
  • Company's CEO, Dr. Shai Yarkoni, was selected to provide the keynote (Plenary) presentation at the 11th world congress of Regenerative Medicine and Stem Cell technologies in Singapore (http://www.bitcongress.com/rmsc2017/default.asp).

Third Quarter 2017 Financial Results:

  • Research and development (R&D) expenses for the third quarter of 2017 were $0.81 million, compared to $0.69 million in the second quarter of 2017 and $0.58 million in the third quarter of 2016. The increase in the third quarter of 2017 as compared to the second quarter of 2017 mainly derived due to a grant received from the BIRD foundation in the amount of $0.12 million in the second quarter of 2017 which was not received in the third quarter of 2017.
  • General and administrative (G&A) expenses for the third quarter of 2017 were $0.99 million, compared to $1.0 million in the second quarter of 2017 and $0.77 million in the third quarter of 2016. The change in the third quarter of 2017 as compared to the second quarter of 2017 mainly derived from an increase in expenses related to business development and professional fees in the third quarter of 2017, offset by a decrease in costs of delisting from the second quarter of 2017.
  • Finance expenses for the third quarter of 2017 were $0.41 million, compared to finance income of $0.37 million in the second quarter of 2017. The change was primarily due to changes related to fair value of the tradable and non-tradable warrants issued in prior financings.
  • Net loss for the third quarter of 2017 was $2.2 million, or $0.02 per share and $0.4 per ADS, compared to $1.3 million, or $0.012 per share and $0.24 per ADS, in the second quarter of 2017 and $1.5 million, or $0.016 per share and $0.3 per ADS, in the third quarter of 2016.

Balance Sheet Highlights:

  • Cash and cash equivalents, marketable securities and short-term deposits totaled $9.2 million as of September 30, 2017, compared to $6.3 million on June 30, 2017, and $8.8 million on December 31, 2016. The increase from June 30, 2017, was primarily due to proceeds of $4.2 million (after deducting placement agents' fees) raised through a registered direct offering and concurrent private placement completed in September 2017, offset by cash used in operations during the period.
  • Tradable and non-tradable warrants exercisable into ADSs totaled $3.1 million as of September 30, 2017, and represented, according to the international financial reporting standards (IFRS), the fair value of tradable and non-tradable warrants issued in prior financings.
  • Shareholders' equity totaled $5.9 million as of September 30, 2017, compared to $4.3 million on June 30, 2017, and $8.1 million on December 31, 2016.

* For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on September 30, 2017 (U.S. $1 = NIS 3.529).

The Company's unaudited consolidated financial results for the three and nine months ended September 30, 2017 are presented in accordance with International Financial Reporting Standards.

About Cellect Biotechnology Ltd.

Cellect Biotechnology (NASDAQ: "APOP", "APOPW") has developed a breakthrough technology for the selection of stem cells from any given tissue that aims to improve a variety of stem cell applications.

The Company's technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells in quantity and quality that will allow stem cell related treatments and procedures. Cellect's technology is applicable to a wide variety of stem cell related treatments in regenerative medicine and that current clinical trials are aimed at the cancer treatment of bone marrow transplantations.

Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss our anticipated performance in 2017 and the potential of our technology and its proposed uses. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov and in the Company's periodic filings with the SEC and the Tel-Aviv Stock Exchange.

 

 

                                                                                    Cellect Biotechnology Ltd.

                                                                               Consolidated Statement of Operation


                               Convenience

                               translation

                               Nine months

                                  ended                                      Nine months ended                     Three months ended

                              September 30,                                    September 30,                         September 30,
                              -------------                                    -------------                         -------------

                                                    2017                                           2017                                  2016        2017       2016
                                                    ----                                           ----                                  ----        ----       ----

                                Unaudited                                            Unaudited
                                ---------                                            ---------

                              U.S. dollars                                              NIS
                              ------------                                              ---

                                         (In thousands, except share and per

                                                     share data)


    Research and
     development expenses                          2,295                                          8,099                                 5,738       2,872      2,059


    General and
     administrative
     expenses                                      2,699                                          9,524                                 6,247       3,478      2,700


    Other income                                       -                                             -                                (280)          -         -
                                                     ---                                           ---                                 ----         ---       ---


    Operating loss                                 4,994                                         17,623                                11,705       6,350      4,759


    Financial expenses due
     to warrants                                   1,933                                          6,821                                   532       1,509        532
       exercisable into ADS


    Other financial
     expenses (income), net                          116                                            411                                   198        (57)       175
                                                     ---                                            ---                                   ---         ---        ---


    Total comprehensive
     loss                                          7,043                                         24,855                                12,435       7,802      5,466
                                                   =====                                         ======                                ======       =====      =====


    Loss per share and ADS:


    Basic and diluted loss
     per share                                     0.065                                          0.228                                 0.145       0.070      0.055
                                                   =====                                          =====                                 =====       =====      =====


    Basic and diluted loss
     per ADS                                       1.292                                           4.56                                  2.90        1.40       1.10
                                                                                                                                       ====        ====       ====


    Weighted average number
     of shares                               109,188,626                                    109,188,626                            85,583,252 111,476,292 98,494,725
       outstanding used to
        compute basic and
       diluted loss per share

 

 

                                                                              Cellect Biotechnology Ltd.

                                                                            Consolidated Balance Sheet Data

                                                                                        ASSETS


                                                                                                                 Convenience

                                                                                                                 translation

                                                                                                                September 30,               September 30,           December 31,
                                                                                                                -------------               -------------           ------------

                                                                                                                                      2017                     2017            2016
                                                                                                                                      ----                     ----            ----

                                                                                                                  Unaudited                   Unaudited               Audited
                                                                                                                  ---------                   ---------               -------

                                                                                                                U.S. dollars                     NIS
                                                                                                                ------------                     ---

                                                                                                        (In thousands, except share and per

                                                                                                                    share data)

    CURRENT ASSETS:

    Cash and cash equivalents                                                                                                        6,396                   22,572           6,279

    Short term deposits, net                                                                                                             -                       -         19,660

    Marketable securities                                                                                                            2,833                    9,996           4,997

    Other accounts receivable                                                                                                          284                    1,004           1,461
                                                                                                                                       ---                    -----           -----


                                                                                                                                     9,513                   33,572          32,397
                                                                                                                                     -----                   ------          ------

    NON-CURRENT ASSETS:

    Restricted cash                                                                                                                     87                      307             140

    Other long-term assets                                                                                                              27                       95               -

    Property, plant and equipment, net                                                                                                 360                    1,270           1,373
                                                                                                                                       ---                    -----           -----


                                                                                                                                       474                    1,672           1,513
                                                                                                                                       ---                    -----           -----


                                                                                                                                     9,987                   35,244          33,910
                                                                                                                                     =====                   ======          ======


                                                                                 LIABILITIES AND

                                                                              SHAREHOLDERS' EQUITY

    CURRENT LIABILITIES:

    Trade payables                                                                                                                     575                    2,027           1,401

    Other accounts payable                                                                                                             368                    1,297           2,084

    Non Traded Warrants to ADS                                                                                                         693                    2,447               -
                                                                                                                                       ---                    -----             ---

                                                                                                                                     1,636                    5,771           3,485
                                                                                                                                     -----                    -----           -----

    NON-CURRENT LIABILITIES:

    Traded Warrants to ADS                                                                                                           2,443                    8,622           1,938
                                                                                                                                     -----                    -----           -----

    EQUITY:

    Ordinary shares of no par value:                                                                                                     -                       -              -
       Authorized: 500,000,000 shares at December 31, 2016
       and September 30 2017; Issued and outstanding:
       107,583,485*) at December 31, 2016;
       119,843,679*) at September 30, 2017.

    Share premium                                                                                                                   22,773                   80,367          67,414

      Capital funds                                                                                                                  2,971                   10,483           6,217

    Treasury shares                                                                                                                (2,671)                 (9,425)        (9,425)

    Accumulated deficit                                                                                                           (17,165)                (60,574)       (35,719)
                                                                                                                                   -------                  -------         -------


                                                                                                                                     5,908                   20,851          28,487
                                                                                                                                     -----                   ------          ------


                                                                                                                                     9,987                   35,244          33,910
                                                                                                                                     =====                   ======          ======

    *) Net of 2,686,693 treasury shares of the Company held by the Company.

 

 

 

                                                         Cellect Biotechnology Ltd.

                                                        Consolidated Cash Flow Data


                                                                                          Convenience

                                                                                          translation

                                                                                          Nine months                     Nine months ended                     Three months ended

                                                                                           ended

                                                                                       September 30,                  September 30,                      September 30,
                                                                                       -------------                  -------------                      -------------

                                                                                       2017          2017                      2016                     2017                      2016
                                                                                       ----          ----                      ----                     ----                      ----

                                                                                         Unaudited                                      Unaudited
                                                                                         ---------                                      ---------

                                                                                        U.S. dollars                                       NIS
                                                                                        ------------                                       ---

                                                                                                       (In thousands)

    Cash flows from operating activities:
    -------------------------------------

    Total comprehensive loss                                                        (7,043)     (24,855)                 (12,435)                 (7,802)                  (5,466)
                                                                                     ------       -------                   -------                   ------                    ------


    Adjustments to reconcile net loss to net
       cash used in operating activities:

    Net financing expenses                                                              143           504                       146                     (29)                      137

    Loss (gain) from revaluation of financial                                            40           140                        21                    (149)                       22
       assets presented at fair value through
       profit and loss

    Depreciation                                                                         79           278                       218                       94                        38

    Capital loss from sell of property, plant and                                         -            -                        9                        -                        -
       equipment

    Changes in fair value of traded and not                                           1,884         6,650                      (77)                   1,337                      (77)
       traded warrants to ADS

    Share-based payment                                                               1,138         4,016                     2,086                    1,572                       576

    Decrease (increase) in other receivables                                            103           362                     (743)                     126                        17

    Increase (decrease) in other payables                                             (179)        (633)                      595                      (4)                    1,090
                                                                                       ----          ----                       ---                      ---                     -----

    Net cash used in operating activities                                           (3,835)     (13,538)                 (10,180)                 (4,855)                  (3,663)
                                                                                     ------       -------                   -------                   ------                    ------


    Cash flows from investing activities:
    -------------------------------------

    Proceeds received from the sale of fixed                                              -            -                       95                        -                        -
       assets

    Short term deposits, net                                                          5,534        19,530                  (19,635)                  18,020                  (19,515)

    Purchase of marketable securities measured                                      (2,834)     (10,000)                        -                (10,000)                        -
       at fair value through profit and loss

    Restricted cash, net                                                               (47)        (167)                        -                     (2)                        -

    Sales of marketable securities measured at                                        1,414         4,991                     1,801                        -                        -
       fair value through profit and loss

    Purchase of property, plant and equipment                                          (50)        (175)                  (1,183)                    (59)                     (59)
                                                                                        ---          ----                    ------                      ---                       ---

    Net cash provided by (used in) investing activities                               4,017        14,179                  (18,922)                   7,959                  (19,574)
                                                                                      -----        ------                   -------                    -----                   -------


    Cash flows from financing activities:
    -------------------------------------

    Exercise of stock options                                                           358         1,263                         7                      197                         -

    Issue of share capital and warrants, net of                                       4,220        14,893                    35,084                   14,893                    27,620
    issue costs


    Net cash provided by financing activities                                         4,578        16,156                    35,091                   15,090                    27,620
                                                                                      -----        ------                    ------                   ------                    ------

    Exchange differences on balances of cash                                          (143)        (504)                    (146)                      29                     (137)
       and cash equivalents

    Increase in cash and cash equivalents                                             4,617        16,293                     5,843                   18,223                     4,246

    Balance of cash and cash equivalents at the                                       1,779         6,279                     3,913                    4,349                     5,510
       beginning of the period


    Balance of cash and cash equivalents at                                           6,396        22,572                     9,756                   22,572                     9,756
       the end of the period

 

 

Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
www.cellect.co
+972-9-974-1444

 

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SOURCE Cellect Biotechnology Ltd.

 
 
Company Codes: NASDAQ-SMALL:APOP, TelAviv:APOP
 
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