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 May 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 May 22, 2019, Anchiano Therapeutics Ltd. announced its first quarter 2019 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 May 22, 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 May 22, 2019

 

 

 

 

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

Anchiano Therapeutics Reports First Quarter 2019 Financial Results

 

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

 

CAMBRIDGE, Mass., May 22, 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 first quarter ended March 31, 2019.

 

Key Developments and Recent Highlights

 

· Closed an initial public offering (“IPO”) of Anchiano's American Depositary Shares (“ADSs”) 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.”

 

· Following the IPO, Anchiano’s financial resources are expected to meet its needs until the second quarter of 2020.

 

· Initiated delisting of its ordinary shares from the Tel Aviv Stock Exchange (TASE). The last day the ordinary shares will trade on the TASE is expected to be June 13, 2019, and the ordinary shares are expected to be delisted from the TASE on June 17, 2019.

 

“We are pleased with the progress we have made this quarter as a company, with the continued development of inodiftagene, our gene therapy for bladder cancer; our U.S. IPO and Nasdaq listing; and the subsequent steps we have taken to delist from the TASE,” stated Frank Haluska, M.D., Ph.D., President and Chief Executive Officer of Anchiano. “We believe we are now well positioned with a U.S.-based clinical development operation, a strong U.S. shareholder base, a strong balance sheet, and an exciting product candidate in its pivotal phase of development. We look forward to announcing several clinical milestones this year as we continue the Codex pivotal clinical trial of inodiftagene for the treatment of early-stage bladder cancer.”

 

First Quarter 2019 Financial Results:

 

On March 31, 2019, Anchiano had total cash and cash equivalents of approximately $32.1 million, compared to approximately $7.5 million on December 31, 2018.

 

Research and development expenses for the first quarter of 2019 were approximately $4.1 million, compared to approximately $2.5 million in the first quarter of 2018. The increase was mainly due to an increase in clinical trial expenses, manufacturing expenses and an increase in clinical manpower.

 

General and administrative expenses for the first quarter of 2019 were approximately $1.3 million, compared to approximately $0.9 million in the first quarter of 2018. The increase was mainly due to an increase in professional and consulting expenses, insurance, rent expenses, and employee options and payroll provisions.

 

Financing expenses, net, in the first quarter of 2019 were approximately $12.9 million compared to approximately $0.08 million in the first quarter of 2018. This change was mainly due to changes in the fair value of derivative financial instruments.

 

 

 

 

Net loss for the f irst quarter of 2019 was approximately $18.4 million, or $0.70 per share, compared to approximately $3.5 million, or $0.37 per share in the first quarter of 2018.

 

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 vixteplasmid, is a gene-therapy product candidate that 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 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 (unaudited)

U.S. dollars in thousands

 

    Fiscal Quarter Ended March 31,  
    2019     2018  
Operating expenses                
Research and development expenses     4,141       2,475  
General and administrative expenses     1,293       926  
Operating loss     5,434       3,401  
Financing expenses, net     12,873       76  
Loss before income tax     18,307       3,477  
Income tax     140       62  
Net loss for the period     18,447       3,539  

 

QUARTERLY STATEMENTS OF FINANCIAL POSITION (unaudited)

U.S. dollars in thousands

 

   

March 31,

2019

    December 31, 2018  
Assets                
Current Assets     33,354       10,920  
Non-Current Assets     3,426       1,654  
Total Assets     36,780       12,574  
Liabilities                
Current Liabilities     4,750       10,036  
Non-Current Liabilities     5,682       3,628  
Total Liabilities     10,432       13,664  
Equity                
Total equity (deficiency)     26,348       (1,090 )
Total Liabilities and Equity     36,780       12,574  

 

CASH FLOWS (unaudited)

U.S. dollars in thousands

 

    Fiscal Quarter Ended March 31,  
    2019     2018  
Net cash used in operating activities     (2,996 )     (2,677 )
Net cash used in investing activities     (75 )     (104 )
Net cash provided by financing activities     27,699       2,000  
Net increase (decrease) in cash and cash equivalents     24,628       (781 )