Anchiano Therapeutics Reports Year-End 2019 Financial Results

CAMBRIDGE, Mass., March 18, 2020 (GLOBE NEWSWIRE) -- 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 the year ended December 31, 2019.

Key Developments

• Entered into an exclusive worldwide collaboration and option to license agreement on September 20, 2019 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 more than 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. On February 26, 2020, the Company’s board of directors determined to advance the preclinical development of our pan-RAS inhibitor program while seeking to identify financing and strategic opportunities for the company.
  
   
• Announced the discontinuation of Anchiano’s 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 was 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 indicated a low probability of achieving an efficacy profile that in Anchiano’s estimation would be necessary to support regulatory approval. At the time the study was discontinued, 16 patients had been evaluable after the first disease assessment on treatment; of these, three (3/16, 19%) experienced a complete response. The safety data on the investigational product were consistent with those observed in prior trials. Anchiano is in the process of closing the study.
  
   
• Anchiano’s Board of Directors approved its management’s recommendation to close Anchiano’s office and laboratory located in Israel. The decision to close the office and laboratory in Israel was made primarily due to the discontinuation of Anchiano’s Phase 2 Codex study and is consistent with the intention of focusing resources on the pan-RAS and PDE10/ß-catenin programs. Following the closure of the Israeli facilities, planned for the second quarter of 2020, Anchiano’s sole office will be located in Cambridge, Massachusetts.

Year Ended December 31, 2019 Financial Results:

On December 31, 2019, Anchiano had total cash and cash equivalents of approximately $17.6 million. Financial resources are expected to suffice through the end of 2020.

Research and development expenses for the year ended December 31, 2019 were approximately $13.3 million, compared to approximately $7.5 million for the same period in 2018. This increase was mainly due to an increase in clinical trial expenses, manufacturing expenses and manpower expenses, as well as additional startup and initial ongoing expenses in connection with the Collaboration Agreement with ADT.

General and administrative expenses for the year ended December 31, 2019 were approximately $6.2 million, compared to expenses of approximately $5.5 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 year ended December 31, 2019 were approximately $4.2 million, compared to approximately $457 thousand for the same period in 2018. This change was mainly due to a revaluation of investor warrants at fair value during a period where these could not be classified within shareholders’ equity.

Restructuring expenses in the year ended December 31, 2019 were approximately $3.4 million, and were comprised principally of contract termination costs and employee severance and associated termination costs related to the reduction of workforce resulting from Anchiano’s decision to discontinue its Phase 2 Codex as described above.

Net loss for the year ended December 31, 2019 was approximately $27.1 million compared to approximately $13.8 million 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 its headquarters in Cambridge, MA. Anchiano is developing small-molecule pan-RAS inhibitors and inhibitors of PDE10 and the β-catenin pathway. For more information on Anchiano, please visit .

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 10-K for the year ended December 31, 2019. 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

Investor Contact:

Ashley R. Robinson

Managing Director

LifeSci Advisors, LLC

617-430-7577

RESULTS OF OPERATIONS (unaudited)

U.S. dollars in thousands

STATEMENTS OF FINANCIAL POSITION (unaudited)

U.S. dollars in thousands

CASH FLOWS (unaudited)

U.S. dollars in thousands