0001104659-19-064557.txt : 20191115 0001104659-19-064557.hdr.sgml : 20191115 20191115085818 ACCESSION NUMBER: 0001104659-19-064557 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20191115 FILED AS OF DATE: 20191115 DATE AS OF CHANGE: 20191115 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: 191222580 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 tm1922583d2_6k.htm FORM 6-K

 

 

  UNITED STATES  

SECURITIES AND EXCHANGE COMMISSION  

WASHINGTON, D.C. 20549

 

 

FORM 6-K
 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT
TO RULE 13a-16 or 15d-16 UNDER THE 

SECURITIES EXCHANGE ACT OF 1934

 

For the month of November 2019

 

Commission File Number: 001-38807

 

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 office)

 

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): ¨ 

 

 

 

 

 

On November 15, 2019, Anchiano Therapeutics Ltd. (the “Company”) announced the discontinuation of its Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC). After a thorough analysis of the data, the Company determined that there is a low probability of surpassing the pre-defined futility threshold at the planned interim analysis, which required 10 complete responses in 35 patients. The data also indicate a low probability of achieving an efficacy profile that, in the Company’s estimation, would be necessary to support regulatory approval. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

In addition, on November 15, 2019, the Company announced its third quarter 2019 financial results. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated by reference herein.

 

In addition, on November 15, 2019, the Board of Directors of the Company (the “Board”) appointed Dennison Veru, a long-standing Board member, to serve as interim Chairman of the Board, effectively immediately.

 

Exhibit Index

 

No.   Description
99.1   Press Release dated November 15, 2019
     
99.2   Press Release dated November 15, 2019

 

 

 

 

SIGNATURE

 

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.

 

Date: November 15, 2019

 

 

Anchiano Therapeutics Ltd.

   
   
  By: /s/ Dr. Frank G. Haluska
    Name: Dr. Frank G. Haluska
    Title: Chief Executive Officer

 

 

 

 EX-99.1 2 tm1922583d2_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

Anchiano Discontinues Phase 2 Codex Study Evaluating Inodiftagene Vixteplasmid in Patients with Non-Muscle-Invasive Bladder Cancer (NMIBC); Company Focuses on Advancing Pan-RAS Inhibitor Program

  

CAMBRIDGE, Mass., November 15, 2019 – Anchiano Therapeutics Ltd. (Nasdaq: ANCN) (“Anchiano” or the “Company”), a biopharmaceutical company focused on discovery and development of targeted therapies to treat cancer, today announced the discontinuation of its Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC). After a thorough analysis of the data, Anchiano determined that there is a low probability of surpassing the pre-defined futility threshold at the planned interim analysis, which required 10 complete responses in 35 patients. The data also indicate a low probability of achieving an efficacy profile that in the company’s estimation would be necessary to support regulatory approval.

 

As of November 14, 2019, 16 patients were evaluable after the first disease assessment on treatment; of these, three (3/16, 19%) have experienced a complete response. The safety data on the investigational product were consistent with those observed in prior trials. Anchiano has taken steps to notify study investigators that enrollment and further treatment of patients on trial should stop immediately and will work to close the study in the coming weeks.

 

"We are disappointed by the results of the Codex study, as we recognize the urgent need for new effective therapies for patients with non-muscle-invasive bladder cancer. We thank the patients, caregivers and investigators involved in our clinical study,” said Frank Haluska M.D., Ph.D., President and Chief Executive Officer of Anchiano.

 

The Company will devote its full resources to its small-molecule pan-RAS inhibitor and PDE10/β-catenin inhibitor programs. Anchiano recently acquired the option to  exclusively license these programs from ADT Pharmaceuticals. The Company believes that the promise and value of these programs provide the greatest potential benefit for patients, and for shareholders, moving forward. The initial focus will be on accelerating the efforts to move the pan-RAS inhibitors toward the clinic. Oncogenic mutations in the RAS family of genes (KRAS, HRAS, and NRAS) are present in approximately 30% of all cancers. The Company believes that successful development of its pan-RAS-targeted therapy, with activity regardless of RAS isoform or mutation, has the potential for significant clinical impact across a variety of tumor types including lung, colorectal, pancreatic, melanoma and bladder cancer, and represents a substantial commercial opportunity.

 

Dr. Haluska added, “The decision to terminate Codex was made with strategic considerations in mind, and facilitates our efficiently redirecting resources and future investment into our pan-RAS inhibitor program. This is consistent with our commitment to develop targeted oncology therapies addressing significant patient populations.” 

 

On September 30, 2019, the Company had total cash and cash equivalents of approximately $23.2 million, compared to approximately $7.5 million on December 31, 2018. Financial resources are expected to suffice until the fourth quarter of 2020.

 

 

 

 

About Anchiano

 

Anchiano is a biopharmaceutical company dedicated to the discovery, development, and commercialization of novel targeted therapies to treat cancer in areas of significant clinical need, with offices in Cambridge, MA, and Jerusalem, Israel. Anchiano is developing small-molecule pan-RAS inhibitors and inhibitors of PDE10 and the b-catenin pathway. 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

617-430-7757

arr@lifesciadvisors.com

 

 

 EX-99.2 3 tm1922583d2_ex99-2.htm EXHIBIT 99.2

 

Exhibit 99.2

 

 

FOR IMMEDIATE RELEASE

 

Anchiano Therapeutics Reports Third Quarter 2019 Financial Results and Provides Corporate Update

 

CAMBRIDGE, Mass., Nov. 15, 2019 - Anchiano Therapeutics Ltd. (Nasdaq: ANCN) (“Anchiano”), a biopharmaceutical company focused on discovery and development of novel therapies to treat cancer, today reported financial results for its third quarter and nine months ended September 30, 2019.

 

Key Developments and Recent Highlights

·Announced the discontinuation of its Phase 2 Codex study evaluating the gene therapy inodiftagene vixteplasmid in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC). After a thorough analysis of the data, Anchiano determined that there is a low probability of surpassing the pre-defined futility threshold at the planned interim analysis, which required 10 complete responses in 35 patients. The data also indicate a low probability of achieving an efficacy profile that in Anchiano’s estimation would be necessary to support regulatory approval. As of November 14, 2019, 16 patients were evaluable after the first disease assessment on treatment; of these, three (3/16, 19%) have experienced a complete response. The safety data on the investigational product were consistent with those observed in prior trials. Anchiano has taken steps to notify study investigators that enrollment and further treatment of patients on trial should stop immediately and will work to close the study in the coming weeks.

 

·Entered into an exclusive worldwide collaboration and option to license agreement with ADT Pharmaceuticals, LLC (“ADT”) to develop novel small-molecule pan-RAS inhibitors and PDE10/β-catenin inhibitors aimed at difficult-to-treat, genetically-defined cancers, underscoring Anchiano’s focus on developing therapies with targeted approaches. Oncogenic mutations in the RAS family of genes (KRAS, HRAS, and NRAS) are present in approximately 30% of all cancers. Anchiano believes that successful development of its pan-RAS-targeted therapy, with activity regardless of RAS isoform or mutation, has the potential for significant clinical impact across a variety of tumor types including lung, colorectal, pancreatic, melanoma and bladder cancer, and represents a substantial commercial opportunity. The agreement grants Anchiano an exclusive option to license the RAS and PDE10/β-catenin inhibitors in exchange for a $3 million upfront payment to ADT and funding of certain research activities. At any time through obtaining an Investigational New Drug (IND) designation, Anchiano has the option to exclusively license the compounds worldwide and will be responsible for all aspects of pre-clinical and clinical development and global commercialization. If Anchiano exercises its option, it will be responsible for development and commercialization and will incur additional payment obligations, including milestone and royalty payments to ADT.

 

Third Quarter 2019 Financial Results:

 

On September 30, 2019, Anchiano had total cash and cash equivalents of approximately $23.2 million, compared to approximately $7.5 million on December 31, 2018. Financial resources are expected to suffice until the fourth quarter of 2020.

 

 

 

 

Research and development expenses for the third quarter of 2019 were approximately $2.2 million, compared to approximately $ 1.4 million for the third quarter of 2018. This increase was mainly due to an increase in clinical trial expenses and an increase in manpower expenses.

 

General and administrative expenses for the third quarter of 2019 were approximately $1.7 million, compared to approximately $1.1 million for the third quarter of 2018. This increase was mainly due to increases in professional, consulting, rental, insurance and manpower expenses.

 

Financing expenses, net, for the third quarter of 2019 were approximately $12.5 million, compared to approximately $0.1 million for the third quarter of 2018. This change was mainly due to changes in the fair value of derivative financial instruments.

 

Net loss for the third quarter of 2019 was approximately $15.9 million, or $0.43 per share, compared to approximately $2.6 million, or $0.17 per share in the third quarter of 2018.

 

Nine Months Ended September 30, 2019 Financial Results:

 

Research and development expenses for the nine months ended September 30, 2019 were approximately $9 million, compared to approximately $5.7 million for the same period in 2018. This increase was mainly due to an increase in clinical trial expenses, manufacturing expenses and an increase in manpower expenses.

 

General and administrative expenses for the nine months ended September 30, 2019 were approximately $4.8 million, compared to expenses of approximately $4.3 million for the same period in 2018. The increase was mainly due to increases in professional fees, insurance and manpower expenses, offset by a decrease in share-based payment.

 

Financing expenses, net, in the nine months ended September 30, 2019 were approximately $22.6 million, compared to approximately $0.9 million for the same period in 2018. This change was mainly due to changes in the fair value of derivative financial instruments.

 

Net loss for the nine months ended September 30, 2019 was approximately $36.2 million, or $1.08 per share, compared to approximately $11.5 million, or $0.98 per share for the same period in 2018.

 

About Anchiano

 

Anchiano is a biopharmaceutical company dedicated to the discovery, development, and commercialization of novel targeted therapies to treat cancer in areas of significant clinical need, with offices in Cambridge, MA, and Jerusalem, Israel. Anchiano is developing small-molecule pan-RAS inhibitors and inhibitors of PDE10 and the b-catenin pathway. 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

617-430-7577

arr@lifesciadvisors.com

 

 

 

 

RESULTS OF OPERATIONS (unaudited)

U.S. dollars in thousands

 

  

Nine Months Ended

September 30,

   Three Months Ended
September 30,		 
   2019   2018   2019   2018 
Operating expenses                    
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 expenses, net   22,555    941    12,454    60 
Loss before income tax    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 

 

STATEMENTS OF FINANCIAL POSITION (unaudited)

U.S. dollars in thousands

 

  

September 30, 2019

   December 31, 2018 
Assets          
Current Assets    24,478    10,920 
Non-Current Assets    6,379    1,654 
Total Assets   30,857    12,574 
Liabilities           
Current Liabilities    15,313    10,036 
Non-Current Liabilities   6,258    3,628 
Total Liabilities   21,571    13,664 
Equity           
Total equity (deficiency)    9,286    (1,090)
Total Liabilities and Equity    30,857    12,574 

 

CASH FLOWS (unaudited)

U.S. dollars in thousands

 

   Nine Months Ended September 30, 
   2019   2018 
Net cash used in operating activities   (10,196)   (11,223)
Net cash used in investing activities   (346)   (312)
Net cash provided by financing activities   26,254    21,162 
Effect of exchange rate differences on cash and cash equivalents   13    (169)
Net increase in cash and cash equivalents    15,725    9,458 

 

 

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