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 March 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 whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:

 

Yes ¨ No x

 

 

 

 

 

On March 12, 2019, Anchiano Therapeutics Ltd. announced its fourth quarter and full year 2018 financial results. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Exhibit No. Description of Exhibit
   
99.1 Press Release dated March 12, 2019

 

 

 

 

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 March 12, 2019      

  

 

 

Exhibit 99.1

 

ANCHIANO THERAPEUTICS

 

FOR IMMEDIATE RELEASE

 

Anchiano Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results

 

– Successfully Completed $30.5 million U.S. Initial Public Offering in February 2019 –

 

– Interim Analysis of the Codex Clinical Trial Expected in Fourth Quarter 2019 –

 

 

CAMBRIDGE, Mass., March 12, 2019 - Anchiano Therapeutics Ltd. (Nasdaq and TASE: ANCN) (“Anchiano”), a pivotal-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat cancer, today reported financial results for its fourth quarter and year ended December 31, 2018.

 

Key Developments and Recent Highlights

 

· Closed an initial public offering (“IPO”) on February 14, 2019, resulting in gross proceeds of $30.5 million. The ADSs began trading on the Nasdaq Capital Market (“Nasdaq”) under the symbol “ANCN”. The net proceeds from Anchiano’s IPO are held in cash and cash equivalents and are expected to fund operations until the end of the second quarter of 2020.

 

· Initiated its Codex Clinical Trial in December 2018 for the development of its lead product candidate inodiftagene vixteplasmid (“inodiftagene”), a recombinant DNA construct designed to be administered to patients with early stage bladder cancer. The single-arm, open label study is designed to test the effects of inodiftagene in a setting unresponsive to bacillus Calmette-Guérin (“BCG”). An interim analysis of the Codex Clinical Trial is expected to be completed during the fourth quarter of 2019.

 

Fourth Quarter and Full Year 2018 Financial Results:

 

· On December 31, 2018, Anchiano had total cash and cash equivalents of approximately $7.5 million, compared to approximately $1.5 million on December 31, 2017.

 

· Research and development expenses incurred in the fourth quarter and fiscal year ended December 31, 2018, respectively, were approximately $1.8 million and $7.6 million, compared to approximately $1.0 million and $6.2 million incurred in the fourth quarter and fiscal year ended December 31, 2017, respectively. This increase was mainly due to an increase in clinical trial initiation expenses, manufacturing expenses and an increase in clinical manpower.

 

· General and administrative expenses incurred in the fourth quarter and fiscal year ended December 31, 2018, respectively, were approximately $1.2 million and $5.5 million, compared to approximately $0.9 million and $3.2 million incurred in the fourth quarter and fiscal year ended December 31, 2017, respectively. This increase was mainly due to an option grant to our Chief Executive Officer and increases in payroll provisions, professional and consulting expenses and rent expenses.

 

· Financing (income) expense, net, in the fourth quarter and fiscal year ended December 31, 2018, respectively, was approximately $(1.3) million and $(0.4) million, compared to approximately $(0.05) million and $0.1 million in the fourth quarter and fiscal year ended December 31, 2017, respectively. This change was due to issuance costs related to the derivative financial instruments issued in the second quarter of 2018, changes in the fair value of derivative financial instruments, and exchange rate fluctuations.

 

· In summary, net loss for the fourth quarter and fiscal year ended December 31, 2018, respectively, was approximately $1.8 million and $13.3 million, compared to approximately $1.9 million and $9.8 million in the fourth quarter and fiscal year ended December 31, 2017.

 

 

 

 

About Anchiano

Anchiano is a pivotal-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat cancer, with offices in Cambridge, MA, and Jerusalem, Israel. Anchiano’s most advanced product candidate, inodiftagene, is in development as a treatment for non-muscle-invasive bladder cancer. For more information on Anchiano, please visit www.anchiano.com.

 

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to risks and uncertainties. Words such as “believes,” “intends,” “expects,” “projects,” “anticipates” and “future” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions, many of which are beyond the control of Anchiano, including, without limitation, the risk factors and other matters set forth in its filings with the Securities and Exchange Commission, including, when filed, its Annual Report on Form 20-F for the year ended December 31, 2018. Anchiano undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

 

Company Contact:

Frank Haluska, M.D., Ph.D.

President and Chief Executive Officer

info@anchiano.com

 

Investor Contact:

Ashley R. Robinson

Managing Director

LifeSci Advisors, LLC

617-535-7742

arr@lifesciadvisors.com

 

 

 

 

QUARTERLY RESULTS OF OPERATIONS

U.S. dollars in thousands

    Fiscal Quarter Ended December 31,  
    2018     2017  
Operating expenses:            
Research and development expenses     1,837       1,007  
General and administrative expenses     1,139       875  
Operating loss     2,976       1,882  
Financing income, net     (1,327 )     (47 )
Loss before taxes on income     1,649       1,835  
Income tax     160       113  
Net loss     1,809       1,948  

 

 

CASH FLOWS

U.S. dollars in thousands

    Fiscal Quarter Ended December 31,  
    2018     2017  
Net cash used in operating activities     (3,521 )     (1,889 )
Net cash used in investing activities     (26 )     (8 )
Net cash provided by financing activities     -       7  
Net increase (decrease) in cash and cash equivalents     (3,547 )     (1,890 )

 

 

 

 

CONSOLIDATED FINANCIAL DATA

U.S. dollars in thousands, except for per share data

 

    Fiscal Year Ended December 31,  
    2018     2017  
             
Consolidated Statements of Operations:            
Operating expenses:            
Research and development expenses     7,559       6,229  
General and administrative expenses     5,485       3,163  
Operating loss     13,044       9,392  
Financing expense (income), net     (386 )     91  
Loss before taxes on income     12,658       9,483  
Income tax     621       323  
Net loss     13,279       9,806  
Net loss per ordinary share     1.05       1.09  

 

  Fiscal Year Ended December 31,  
    2018     2017  
Consolidated Statements of Financial Position Data:            
Cash and cash equivalents     7,517       1,454  
Working capital     884       (842 )
Total assets     12,574       2,087  
Total liabilities     13,664       2,696  
Total shareholders’ equity (deficiency)     (1,090 )     (609 )

 

CASH FLOWS

U.S. dollars in thousands

    Fiscal Year Ended December 31,  
    2018     2017  
Net cash used in operating activities     (14,744 )     (8,515 )
Net cash used in by investing activities     (338 )     (34 )
Net cash provided by financing activities     21,162       5,242  
Net increase (decrease) in cash and cash equivalents     6,080       (3,307 )