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Can-Fite Reports Third Quarter 2019 Financial Results & Provides Clinical Update

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  • Reached agreement with U.S. FDA on Phase III liver cancer study design & initiated compassionate use program in Israel
  • Signed new distribution deal for Piclidenoson in South Korea
  • Entered into strategic agreement to develop cannabinoid-based pharmaceuticals and assays

 

Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced financial results for the nine months ended September 30, 2019.

Clinical and corporate developments during Q3 2019 and shortly after the end of the quarter include:

  • Reached Agreement with U.S. FDA on Phase III Study Design for Namodenoson in Liver Cancer – Can-Fite concluded a successful End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA) regarding its recently completed Phase II study of Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer. The FDA agreed with Can-Fite's proposed pivotal Phase III trial design to support a New Drug Application submission and approval. The Phase III study design is now being finalized based on guidance from the FDA, and Can-Fite expects to initiate the study in the second half of 2020.
  • Treating Liver Cancer Patients Under Compassionate Use – Can-Fite enrolled and started treating HCC patients with Namodenoson under its compassionate use program at the Rabin Medical Center in Israel. The approved compassionate use program gives HCC patients early access to treatment with Namodenoson when patients have exhausted other available treatment options.
  • Completed Patient Enrollment in Phase II NASH Study – Can-Fite completed enrollment of 60 patients with NAFLD (non-alcoholic fatty liver disease) with or without NASH (non-alcoholic steatohepatitis). The Company plans to announce topline results in the first quarter of 2020
  • Signed Distribution Deal for Piclidenoson in South Korea & Received Upfront Payment – Can-Fite entered into an exclusive distribution agreement with Kyongbo Pharm for Piclidenoson in the treatment of psoriasis in South Korea. Can-Fite received an upfront payment of $750,000, and the agreement includes milestone payments of up to $3,250,000 plus transfer pricing on the drug, upon regulatory approval in South Korea.
  • Enrolling Patients in Phase III Studies for Piclidenoson in Rheumatoid Arthritis and Psoriasis -- Can-Fite and Gebro Pharma conducted an International Advisory Board conference for the development and commercialization of Piclidenoson with a panel of Key Opinion Leaders in rheumatoid arthritis from Austria, Switzerland, and Spain, the markets for which Gebro has licensed the distribution rights to Piclidenoson for rheumatoid arthritis and psoriasis. Can-Fite is currently enrolling and treating patients in Phase III global studies for these two indications.
  • Entered Collaboration Agreement to Develop Cannabinoid-Based Pharmaceuticals and Assays – Can-Fite signed an agreement with Univo Pharmaceuticals (TASE:UNVO), a medical cannabis company, to identify and co-develop specific formulations of cannabis components for the treatment of cancer, inflammatory, autoimmune, and metabolic diseases. Can-Fite will contribute its unparalleled expertise in A2AR, which binds with cannabinoids, and is the target of Can-Fite's technology platform. The transaction involves technology exchange, co-development, and revenue share on CBD-based pharmaceuticals and CBD-based A3AR assays.
  • Granted Patents for Sexual Dysfunction Drug, Evaluating Strategic Partnerships - Can-Fite increased its patent portfolio for its drug candidate CF602 in the treatment of sexual dysfunction. Patents were recently granted in Canada, South Korea, and Israel for its patent titled, "A3 adenosine receptor ligands for use in treatment of a sexual dysfunction". CF602 has a unique mechanism of action that makes it suitable to potentially treat sexual dysfunction safely in patients with diabetes mellitus, a clear and unmet need in the market today. Can-Fite is actively looking for and evaluating potential strategic partners that may in-license and develop CF602 in this indication.

"We are very pleased with the outcome of our End-of-Phase II meeting with FDA regarding Namodenoson in the treatment of liver cancer. As we advance towards a pivotal Phase III study in liver cancer, HCC patients in Israel now have access to Namodenoson through our approved compassionate use program. We look forward to several milestones in 2020, including topline results from our Phase II NASH study, initiation of our Phase III liver cancer study, ongoing enrollment in our Phase III studies for Piclidenoson, as well as our development agreement with Univo, to develop cannabis derived pharmaceuticals and screening based assays" stated Can-Fite CEO Pnina Fishman.

Financial Results

Revenues for the nine months ended September 30, 2019 were $1.84 million compared with $3.53 million for the same period of 2018. The decrease in revenues was mainly due to the recognition of $2 million advance payment received in August 2018 under the distribution agreement with CMS Medical.

Research and development expenses for the nine months ended September 30, 2019 were $7.01 million compared with $4.05 million for the same period of 2018. Research and development expenses for the nine months ended 2019 comprised primarily of expenses associated with the Phase II studies for Namodenoson in the treatment of NASH and HCC, as well as expenses for ongoing Phase III studies of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis.

General and administrative expenses were $2.22 million for the nine months ended September 30, 2019 compared to $2.39 million for the same period in 2018. The decrease is primarily due to a decrease in professional services and investor relations an expense which was partly offset by an increase in insurance expenses.

Financial income, net for the nine months ended September 30, 2019 was $0.44 million compared to financial income, net of $0.23 million for the same period in 2018. The increase in financial income, net is mainly due to fair value revaluation of the investment in Wize Pharma's shares which is classified under short term investment.

Can-Fite's net loss for the nine months ended September 30, 2019 was $7.84 million compared with a net loss of $3.14 million for the same period in 2018. As of September 30, 2019, Can-Fite had cash and cash equivalents of $4.68 million as compared to $3.62 million at December 31, 2018. The increase in cash and cash equivalents is due to net cash provided by financing activity of $10.1 million which was offset by net cash used in operating activity of $9.1 million.

The Company's consolidated financial results for the nine months ended September 30, 2019 are presented in accordance with International Financial Reporting Standards.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

In thousands (except for share and per share data)

 

 

September 30,

 

December 31,

 

 

2019

 

2018

 

 

Unaudited

 

Audited

 

 

USD

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

4,682

 

3,615

Other receivable and prepaid expenses

 

5,160

 

4,015

Short-term investment

 

111

 

273

 

 

 

 

 

Total current assets

 

9,953

 

7,903

 

 

 

 

 

NON-CURRENT ASSETS:

 

 

 

 

 

 

 

 

Other receivables

 

1,750

 

-

Lease deposits

 

11

 

2

Property, plant and equipment, net

 

37

 

47

 

 

 

 

Total long-term assets

 

1,798

 

49

 

 

 

 

Total assets

 

11,751

 

7,952

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

In thousands (except for share and per share data)

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