0001104659-19-066289.txt : 20191121 0001104659-19-066289.hdr.sgml : 20191121 20191121170058 ACCESSION NUMBER: 0001104659-19-066289 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20191121 FILED AS OF DATE: 20191121 DATE AS OF CHANGE: 20191121 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Anchiano Therapeutics Ltd. CENTRAL INDEX KEY: 0001534248 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38807 FILM NUMBER: 191237963 BUSINESS ADDRESS: STREET 1: 1/3 HIGH-TECH VILLAGE STREET 2: GIVAT RAM, P.0. BOX 39264 CITY: JERUSALEM STATE: L3 ZIP: 9139102 BUSINESS PHONE: 972-2-5486555 MAIL ADDRESS: STREET 1: 1/3 HIGH-TECH VILLAGE STREET 2: GIVAT RAM, P.0. BOX 39264 CITY: JERUSALEM STATE: L3 ZIP: 9139102 FORMER COMPANY: FORMER CONFORMED NAME: BioCancell Ltd. DATE OF NAME CHANGE: 20111104 6-K 1 tm1922583-3_6k.htm FORM 6-K

 

 

 

SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of November 2019

 

 

 

Anchiano Therapeutics Ltd.

 

(Translation of registrant’s name into English)

 

 

 

1/3 High-Tech Village, Givat Ram, P.O. Box 39264

Jerusalem, 9139102 Israel

 

(Address of Principal Executive Offices)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F    x Form 40-F    ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

 

 

 

 

 

Anchiano Therapeutics Ltd. (“Anchiano”) is hereby filing its third quarter 2019 financial results (the “Financial Statements”) with the Securities and Exchange Commission in anticipation of a significant shareholder filing its quarterly report with the Israel Securities Authority. Israeli law requires the shareholder to include the Financial Statements due to the significance to that shareholder of its position in Anchiano. The Financial Statements are attached hereto as Exhibit 99.1 and are incorporated herein by reference.

 

Exhibit No.   Description of Exhibit
     
99.1   Financial Statements

 

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Anchiano Therapeutics Ltd.
   
  By:     /s/ Dr. Frank G. Haluska
    Dr. Frank G. Haluska
    Chief Executive Officer

 

Dated November 21, 2019

 

 

 

EX-99.1 2 tm1922583d3_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Anchiano Therapeutics Ltd.

 

Consolidated Interim Financial Statements

September 30, 2019

 

 

 

 

Anchiano Therapeutics Ltd.

 

Condensed Consolidated Interim Financial Statements as of September 30, 2019 (Unaudited) 

 

Contents

 

    Page 
Condensed Consolidated Interim Financial Statements :     
      
Condensed Consolidated Interim Statements of Financial Position   2 
      
Condensed Consolidated Interim Statements of Operations   3 
      
Condensed Consolidated Interim Statements of Operations and Other Comprehensive Loss   4 
      
Condensed Consolidated Interim Statements of Changes in Equity (Deficiency)   5 
      
Condensed Consolidated Interim Statements of Cash Flows   6 
      
Notes to the Condensed Consolidated Interim Financial Statements   7 

 

1

 

 

Condensed Consolidated Interim Statements of Financial Position (Unaudited)

 

$ thousands

 

      September 30,
2019*
   December 31,
2018
 
   Note    (Unaudited)       
              
Assets             
Cash and cash equivalents      23,242    7,517 
Receivables      1,236    3,403 
              
Total current assets      24,478    10,920 
Non-current assets             
Intangible assets  4E   3,346    - 
Long-term prepaid expenses      958    1,115 
Right-of-use assets      1,566    - 
Long-term pledged deposits      129    120 
Asset for employee benefits, net      10    34 
Fixed assets, net      370    385 
              
Total non-current assets      6,379    1,654 
              
Total assets      30,857    12,574 
Liabilities              
Trade payables      924    396 
Other payables      3,751    2,021 
Short-term employee benefits      962    644 
Short-term lease liabilities      505    - 
Derivative instruments  4A   9,171    6,975 
              
Total current liabilities      15,313    10,036 
Non-current liabilities             
Long-term lease liabilities      992    - 
Derivative instruments  4A   5,266    3,628 
Total non-current liabilities      6,258    3,628 
              
Total liabilities      21,571    13,664 
Contingent liabilities and commitments             
Equity             
Share capital      -    - 
Additional paid-in capital      116,125    70,595 
Currency translation differences reserve      872    872 
Capital reserve from share-based payments      4,611    3,566 
Accumulated loss      (112,322)   (76,123)
              
Total equity (deficiency)      9,286    (1,090)
              
Total liabilities and equity      30,857    12,574 

 

Dennison Veru   Dr. Frank Haluska   Jonathan Burgin  
Interim Chairman   Chief Executive Officer   Chief Operating Officer & Chief Financial Officer  

 

*See Note 3 - Initial application of new standards
  
Date of approval of the financial statements: November 14, 2019

 

The accompanying notes are an integral part of the consolidated interim financial statements.

 

2

 

 

Anchiano Therapeutics Ltd.

Condensed Consolidated Interim Statements of Operations (Unaudited)

 

$ thousands (Other than per share amounts)

 

   For the nine-month period
ended
   For the three-month period
ended
 
   September 30,   September 30,   September 30,   September 30, 
   2019*   2018   2019*   2018 
                     
Research and development expenses   8,963    5,722    2,233    1,372 
General and administrative expenses   4,811    4,346    1,664    1,133 
                     
Operating loss   13,774    10,068    3,897    2,505 
                     
Financing income   (331)   (12)   (130)   (12)
Financing expense   22,886    953    12,584    72 
                     
Financing expense, net   22,555    941    12,454    60 
                     
Loss before taxes on income   36,329    11,009    16,351    2,565 
                     
Income tax   (154)   461    (433)   68 
                     
Net loss for the period   36,175    11,470    15,918    2,633 
                     
Loss per share (in $):                    
                     
Basic and diluted loss*   1.08    0.98    0.43    0.17 
                     
Number of shares used to compute basic and diluted loss per share (thousands of shares)   33,551    11,666    37,099    15,574 

 

* See Note 3 - Initial application of new standards

 

The accompanying notes are an integral part of the consolidated interim financial statements.

 

3

 

 

Anchiano Therapeutics Ltd.

 

Condensed Consolidated Interim Statements of Operations and Other Comprehensive Loss (Unaudited)

 

$ thousands

 

   For the nine-month period ended   For the three-month period ended 
   September 30,   September 30,   September 30,   September 30, 
   2019*   2018   2019*   2018 
                     
Net loss for the period   36,175    11,470    15,918    2,633 
                     
Other comprehensive income items that will not be transferred to statement of operations                     
                     
Re-measurement of defined benefit plan Currency translation difference   24    (325)   -    15 
                     
Total comprehensive loss for the period   36,199    11,145    15,918    2,648 

 

* See Note 3 - Initial application of new standards

 

The accompanying notes are an integral part of the consolidated interim financial statements.

 

4

 

 

Condensed Consolidated Interim Statements of Changes in Equity (Deficiency) (Unaudited)

 

$ thousands

 

      Share
capital
      Additional
paid-in
capital
      Currency
translation
differences
reserve
      Capital
reserve from
share-based
payments
      Accumulated
loss
      Total equity
(Deficiency)
 
                                                 
For the nine-month period ended September 30, 2019 *                                                
Balance as at January 1, 2019     -       70,595       872       3,566       (76,123 )     (1,090 )
Issuance of shares, net     -       26,500       -       -       -       26,500  
Price protection rights     -       19,006       -       -       -       19,006  
Expiration of options     -       24       -       (24 )     -       -  
Share-based payment     -       -       -       1,069       -       1,069  
Comprehensive loss for the Period     -       -       -       -       (24 )     (24 )
Net loss for the period     -       -       -       -       (36,175 )     (36,175 )
                                                 
Balance as of September 30, 2019     -       116,125       872       4,611       (112,322 )     9,286  
                                                 
For the nine-month period ended September 30, 2018                                                
Balance as of January 1, 2018     -       60,043       457       1,767       (62,876 )     (609 )
Issuance of shares, net     -       10,419       -       -       -       10,419  
Exercise of options     -       7       -       (1 )     -       6  
Share-based payment     -       -       -       1,562       -       1,562  
Comprehensive income for the Period     -       -       325       -       -       325  
Net loss for the period     -       -       -       -       (11,470 )     (11,470 )
                                                 
Balance as of September 30, 2018     -       70,469       782       3,328       (74,346 )     233  

 

* See Note 3 - Initial application of new standards

 

The accompanying notes are an integral part of the consolidated interim financial statements.

 

5

 

 

 

Condensed Consolidated Interim Statements of Cash Flows (Unaudited)

 

$ thousands

 

   For the nine-month period ended 
   September 30,   September 30, 
   2019*   2018 
           
Cash flows from operating activities          
Loss for the period   (36,175)   (11,470)
Financing expenses, net   22,531    866 
Depreciation   70    46 
Share-based payments   1,069    1,562 
Taxes on income   (154)   461 
Right-of-use depreciation   347    - 
Change in receivables   1,477    (2,414)
Change long-term prepaid expenses   70    (803)
Change in trade payables   913    706 
Change in other payables   (382)   (314)
Change in employee benefits   318    400 
Taxes paid   (605)   (244)
Interest paid   (6)   (23)
Interest received   331    4 
           
Net cash used in operating activities   (10,196)   (11,223)
Cash flows from investing activities          
purchase of Intangible Assets   (250)   - 
Change in long pledged deposits   -    (125)
 Purchase of fixed assets   (96)   (187)
           
Net cash used in investing activities   (346)   (312)
Cash flows from financing activities          
Receipt of loan from bank   -    1,050 
Repayment of loan from bank   -    (1,033)
Receipt of loan from controlling shareholder   -    3,000 
Repayment of loan from controlling shareholder   -    (3,000)
Payment for lease liabilities   (367)   - 
Proceeds from issuance of warrants and derivative instruments   -    11,989 
Proceeds from issuance of shares   30,500    10,911 
Issuance costs   (3,879)   (1,755)
           
Net cash provided by financing activities   26,254    21,162 
           
Increase in cash and cash equivalents   15,712    9,627 
           
Cash and cash equivalents at the beginning of the period   7,517    1,454 
           
Effect of exchange rate differences on cash and cash equivalents   13    (169)
           
Cash and cash equivalents at the end of the period   23,242    10,912 

 

* See Note 3 - Initial application of new standards

 

The accompanying notes are an integral part of the consolidated interim financial statements.

 

6

 

 

Anchiano Therapeutics Ltd.

Notes to the Condensed Consolidated Interim Financial Statements as of September 30, 2019 (Unaudited)

  

Note 1 - General

 

A.Anchiano Therapeutics Ltd. (the “Company”) is incorporated in Israel. The official address of the Company is 1/3 High Tech-Village, Givat Ram, Jerusalem Israel. The Company’s American Depositary Shares (“ADSs”), each representing five of the Company’s ordinary shares with no par value are traded on the Nasdaq Capital Market since Febuary 2019 using the symbol “ANCN”, while its ordinary shares were traded on the Tel Aviv Stock Exchange between August 2006 and June 2019.

 

B.    Definitions

 

In these financial statements -

 

(1)The Company - Anchiano Therapeutics Ltd. (formerly BioCanCell Ltd.).

 

(2)Subsidiaries - The Company’s subsidiary, Anchiano Therapeutics Israel Ltd. (formerly BioCancell Therapeutics Israel Ltd.) and its subsidiary Anchiano Therapeutics, Inc. (formerly BioCancell USA, Inc.), whose financial statements are fully consolidated with those of the Company and which are wholly owned and controlled by the Company.

 

(3)The “Anchiano Group”, the “Group”, or “Anchiano” - The Company and the Subsidiaries.

 

(4)Dollars or “$” - U.S. dollars.

 

C.The reporting entity

 

The condensed consolidated interim financial statements of the Company as of September 30, 2019 include those of the Company and of the Subsidiaries.

 

The Anchiano Group is engaged in research and development of drugs for the treatment of cancer. The Group’s products are in the development stage. Therefore, there is no certainty regarding the Group’s ability to complete development of the products, obtain regulatory permits, and achieve marketing success. The Company has incurred recurring losses from operations. The continuation of the stages of development related to the Company’s planned activities depends on future events, including raising additional capital and achieving operational profitability. The Company is working to raise the capital needed for its continuing operations, although, as of the date of the statement of financial position, there is significant doubt as to the Company’s ability to continue operating as a “going concern”. As of the signing date of the financial statements, and based on the Group’s assessments, its financial resources are expected to suffice until the fourth quarter of 2020.

 

These financial statements do not include any measurement or presentation adjustments for assets and liabilities that would be required if the Group does not continue operating as a going concern.

 

7

 

 

Anchiano Therapeutics Ltd.

Notes to the Condensed Consolidated Interim Financial Statements as of September 30, 2019 (Unaudited)

 

Note 2 - Basis of Financial Statement Presentation

 

A.             Declaration of Compliance with International Financial Reporting Standards

 

The condensed consolidated interim financial statements were prepared by the Group in conformity with IAS 34 Interim Financial Reporting. They do not include all the information required in full annual financial statements and should be read in conjunction with the consolidated financial statements for the year ended December 31, 2018, which were prepared in conformity with IFRS as issued by the International Accounting Standards Board (“IASB”).

 

The condensed consolidated interim financial statements were approved for publication by the Company’s Board of Directors on November 14, 2019.

 

B.            Change in functional currency

 

The Company’s management has determined that as a result of a significant increase in the Group’s activities in the USA, including the initiation of a pivotal clinical trial and an initial public offering on the Nasdaq, the Group’s functional currency, best representing the Group’s economic activity, shall be the U.S. dollar as of January 1, 2019. The change in functional currency is accounted for prospectively from the date of change.

 

C.Use of estimates and judgment

 

The preparation of financial statements in conformity with IFRS requires management to exercise judgment when making assessments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates.

 

Except as described below and that mentioned in Note 3, the significant judgments made by management in applying the Group’s accounting policies and the principal assumptions used in the estimation of uncertainty were the same as those that applied to the annual financial statements

 

The Company uses critical estimates to measure the fair value of derivative instruments.

 

8

 

 

Anchiano Therapeutics Ltd.

Notes to the Condensed Consolidated Interim Financial Statements as of September 30, 2019 (Unaudited)

 

Note 3 - Significant Accounting Policies

 

Except as described below, the accounting policies applied by the Group in these condensed consolidated interim financial statements are the same as those applied by the Group in its annual financial statements.

Presented hereunder is a description of the changes in accounting policies applied in these condensed consolidated interim financial statements and their effect:

 

Initial application of new standards, amendments to standards and interpretations

 

As from January 1, 2019, the Group applies the new standards and amendments to standards described below:

 

IFRS 16, Leases

 

As from January 1, 2019 (hereinafter: “the date of initial application”) the Group applies International Financial Reporting Standard 16, Leases (hereinafter: “IFRS 16” or “the standard”), which replaced International Accounting Standard 17, Leases (hereinafter: "IAS 17" or "the previous standard").

 

The main effect of the standard’s application is reflected in annulment of the existing requirement from lessees to classify leases as operating (off-balance sheet) or finance leases and the presentation of a unified model for lessees to account for all leases similarly to the accounting treatment of finance leases in the previous standard. Until the date of application, the Group classified most of the leases in which it is the lessee as operating leases, since it did not substantially bear all the risks and rewards from the assets. Assets leased under a finance lease included mainly office buildings and office furniture.

 

In accordance with IFRS 16, for agreements in which the Group is the lessee, the Group recognizes a right-of-use asset and a lease liability at the inception of the lease contract for all the leases in which the Group has a right to control identified assets for a specified period of time, other than exceptions specified in the standard. Accordingly, the Group recognizes depreciation and amortization expenses in respect of a right-of-use asset, tests a right-of-use asset for impairment in accordance with IAS 36 and recognizes financing expenses on a lease liability. Therefore, as from the date of initial application, lease payments relating to assets leased under an operating lease, which were presented as part of general and administrative expenses in the income statement, are capitalized to assets and written down as depreciation and amortization expenses. Furthermore, leased assets, which were classified as finance leases at inception of the lease and were recognized in the statement of financial position as fixed assets, were reclassified as right-of-use assets.

 

The Group elected to apply the standard using the modified retrospective approach, with an adjustment to the balance of retained earnings as at January 1, 2019 and without a restatement of comparative data. In respect of all the leases, the Group elected to apply the transitional provisions such that on the date of initial application it recognized a liability at the present value of the balance of future lease payments discounted at its incremental borrowing rate at that date calculated according to the average duration of the remaining lease period as from the date of initial application, and concurrently recognized a right-of-use asset at the same amount of the liability, adjusted for any prepaid or accrued lease payments that were recognized as an asset or liability before the date of initial application. Therefore, application of the standard did not have an effect on the Group’s equity at the date of initial application

 

Impact of the application of IFRS 16 in the reporting period

 

As a result of applying IFRS 16, in relation to the leases that were classified as operating leases according to IAS 17, the Group recognized right-of-use assets (including investment property) and lease liabilities as at September 30, 2019 in the amount of $1,566 thousand and $1,497 thousand, respectively.

 

Furthermore, instead of recognizing lease expenses in relation to those leases, during the nine-month period ended September 30, 2019 the Group recognized additional depreciation expenses in the amount of $347 thousand and additional financing expenses in the amount of $42 thousand.

 

9

 

 

Anchiano Therapeutics Ltd.

Notes to the Condensed Consolidated Interim Financial Statements as of September 30, 2019 (Unaudited)

 

Note 3 - Significant Accounting Policies (cont'd)

 

Initial application of new standards, amendments to standards and interpretations (cont’d)

 

IFRS 16, Leases (cont'd)

 

In measurement of the lease liabilities, the Group discounted lease payments using the nominal incremental borrowing rate at January 1, 2019. The discount rates used to measure the lease liability range between 2.7% and 5.3% . This range is affected by differences in the lease term, differences between asset groups, and so forth.

 

Presented hereunder are the main changes in accounting policies following the application of IFRS 16 as from January 1, 2019:

 

(1)       Determining whether an arrangement contains a lease

 

On the inception date of the lease, the Group determines whether the arrangement is a lease or contains a lease, while examining if it conveys the right to control the use of an identified asset for a period of time in exchange for consideration. In its assessment of whether an arrangement conveys the right to control the use of an identified asset, the Group assesses whether it has the following two rights throughout the lease term:

 

(a)       The right to obtain substantially all the economic benefits from use of the identified asset; and

(b)       The right to direct the identified asset’s use.

 

For lease contracts that contain non-lease components, such as services or maintenance, that are related to a lease component, the Group elected to account for the contract as a single lease component without separating the components.

 

(2)       Leased assets and lease liabilities

 

Contracts that award the Group control over the use of a leased asset for a period of time in exchange for consideration, are accounted for as leases. Upon initial recognition, the Group recognizes a liability at the present value of the balance of future lease payments (these payments do not include certain variable lease payments), and concurrently recognizes a right-of-use asset at the same amount of the lease liability, adjusted for any prepaid or accrued lease payments, plus initial direct costs incurred in respect of the lease.

 

Since the interest rate implicit in the Group's leases is not readily determinable, the incremental borrowing rate of the lessee is used. Subsequent to initial recognition, the right-of-use asset is accounted for using the cost model, and depreciated over the shorter of the lease term or useful life of the asset.

 

The Group has elected to apply the practical expedient by which short-term leases of up to one year and/or leases in which the underlying asset has a low value, are accounted for such that lease payments are recognized in profit or loss on a straight-line basis, over the lease term, without recognizing an asset and/or liability in the statement of financial position.

 

(3)       The lease term

 

The lease term is the non-cancellable period of the lease plus periods covered by an extension or termination option if it is reasonably certain that the lessee will or will not exercise the option, respectively.

 

After lease commencement, a right-of-use asset is measured on a cost basis less accumulated depreciation and accumulated impairment losses and is adjusted for re-measurements of the lease liability. Depreciation is calculated on a straight-line basis over the useful life or contractual lease period, whichever earlier, as follows:

 

Buildings and lab 3-5 years
vehicles 3 years

 

10

 

 

Anchiano Therapeutics Ltd.

Notes to the Condensed Consolidated Interim Financial Statements as of September 30, 2019 (Unaudited)

 

Note 4 - Significant EventS during the Report Period

 

A.On February 14, 2019, the Company closed an initial public offering of 2,652,174 ADSs, each representing five ordinary shares of the Company (in total, 13,260,870 ordinary shares), at $11.50 per ADS, resulting in gross proceeds of $30.5 million. Pursuant to price protection rights granted to private investors in 2018 and activated in the offering, the Company allocated an additional 8,262,800 ordinary shares (equivalent to 1,652,560 ADSs) to rights holders and adjusted their warrants to be exercisable for an additional 6,207,330 ordinary shares (equivalent to 1,241,466 ADSs). As a result of that the company recorded an additional $19M to equity. The fair value as of the transaction date of the Derivative Financial Instrument - price protection mechanism was approximately $19 million and the difference in the fair value of $12 million is recognized in the statement of operations as financing expenses.

 

In addition, as of September 30, 2019, the fair value of the Derivative Financial Instrument relating to the warrants and price protection is $14.4 million. The change in fair value between January 1, 2019 and September 30, 2019 was $22.8 million, which was recognized in the statement of operations as financing expenses. The Company used the Probability-Weighted Expected Return Method. The main assumptions underlying the calculation were a share price of $0.46, expected volatility of 57%, a risk-free interest rate range of 1.56% to 1.75%, and no dividend payments during the valuation period.

 

B.At the Company’s request, the TASE de-listed the Company’s ordinary shares from trade on the TASE on June 17, 2019. The Company’s ADSs, each representing five of its ordinary shares, remain traded on the Nasdaq Capital Market under the symbol “ANCN”, and the Company continues to report in accordance with U.S. securities law and Nasdaq rules.

 

C.In July 2019, a general meeting of the Company’s shareholders ratified a resolution of the Company’s Board of Directors from May 2019, amending the annual salary of the Company’s CEO, Dr. Frank Haluska, to $480,000 commencing May 1, 2019, and an allocation of options to him to purchase 422,090 ordinary shares (equivalent to 84,418 ADSs).

 

D.In July 2019, the Company allocated options exercisable into 1,456,590 ordinary shares of the Company (equivalent to 291,318 ADSs) to employees and directors of the Company and its fully-owned subsidiaries (including as described in Note 4C above), at a total cost of approximately $712 thousand. The options were granted following the approval of a general meeting of the Company’s shareholders to which part of the allocation was subject.

 

E.The Company expects to receive a tax refund, pursuant to its tax return for the 2018 financial year, and has updated its tax provision for 2019 accordingly.

 

F.In September 2019, the Company announced that its fully-owned subsidiary Anchiano Therapeutics, Inc. entered into a collaboration and license agreement with ADT Pharmaceuticals, LLC (“ADT”). Pursuant to the terms and conditions set forth in the agreement, the parties agreed to use commercially reasonable efforts to conduct research and development activities of novel small-molecule inhibitors (RAS and PDE10/β-catenin) under the oversight of a joint steering committee established by the parties. As part of the arrangement, Anchiano will be primarily responsible for the research, development, manufacturing and regulatory activities and ADT will assist with the research activities as necessary in exchange for a quarterly fee from Anchiano. In connection with the agreement, ADT also granted Anchiano exclusive rights to research, develop, manufacture and commercialize the aforementioned compounds relating to patents owned by ADT and any products containing such compounds worldwide. In consideration for the rights granted under the agreement, Anchiano will pay ADT (i) a $3 million upfront fee; (ii) a fee upontransfer of the know-how and intellectual property rights to the Company; and then (iii) additional payments, including milestone and royalty payments. Anchiano may terminate the agreement at any time in its entirety or on a compound-by-compound basis after providing 90 days written notice to ADT. $250 thousand of the upfront fee was paid during the period, with the remainder recorded as a short-term liability. The Company accounted for the upfront fee as an intangible asset, in accordance with IAS 38.

 

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Anchiano Therapeutics Ltd.

Notes to the Condensed Consolidated Interim Financial Statements as of September 30, 2019 (Unaudited)

 

Note 4 - Significant EventS during the Report Period (CONT’D)

 

G.In November 2019, after a thorough evaluation of data, Anchiano determined there was a low probability of surpassing the pre-defined futility threshold at the planned interim analysis of its Phase 2 Codex study, evaluating the gene therapy inodiftagene vixteplasmid in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC), and announced the discontinuation of the study. The Group took steps to notify study investigators that enrollment and further treatment of patients on trial should stop immediately and is working to close the study. The Company will now devote its resources to the small-molecule pan-RAS inhibitor and PDE10/β-catenin inhibitor programs, described in Note 4F above. The Company is in the process of examining the costs involved in shutting down the clinical study and is not yet able to determine the expense that will be recorded in the fourth quarter of 2019 as a result of shutting down the clinical study.

 

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