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Can-Fite Reports Third Quarter 2022 Financial Results & Provides Clinical Update

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PETACH TIKVA, Israel, November 25, 2022–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the quarter ended September 30, 2022.

Corporate and Clinical Development Highlights Include:

Complete Clearance of Cancer in a Patient Treated with Namodenoson was Presented at the AASLD Liver Meeting® – A poster titled “Complete Response Induced by Namodenoson, an A3 Adenosine Receptor Agonist, in a Patient with Advanced Hepatocellular Carcinoma” was presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in November in Washington, D.C. The findings were published in the October 2022 supplement of HEPATOLOGY, a premier peer-reviewed journal in the field of liver disease. The poster detailed the patient, a 61-year-old woman with hepatocellular carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), who participated in Can-Fite’s prior Phase II study. The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for 5 years under an open label extension program until the approval of a compassionate use program in Romania in August.

Namodenoson Approved for Compassionate Use in Romania to Treat Liver Cancer; Phase III Pivotal Global Study Open for Enrolment – Romania became the second country to approve Namodenoson for compassionate use in patients with advanced liver cancer. Can-Fite’s global pivotal Phase III liver cancer study for Namodenoson is open for enrollment of approximately 450 patients diagnosed with HCC and underlying CPB7 who have not responded to other approved therapies.

New Psoriasis Data from Phase III COMFORT™ Trial Show Superior Safety & Improved Efficacy – The latest findings on Piclidenoson, Can-Fite’s lead drug candidate, from its Phase III COMFORT trial were presented in September at the 31st European Academy of Dermatology and Venerology by Dr. Kim A. Papp, MD, a prominent thought leader in the treatment of psoriasis. In addition to the study meeting its primary endpoint of Piclidenoson’s superiority over placebo, the latest data showed that Piclidenoson had a significantly better tolerability profile than Otezla, the leading oral psoriasis treatment on the market today. GI-related adverse events were 1% for Piclidenoson vs. 6% for Otezla, nervous system disorders were 0.7% for Piclidenoson vs. 9.9% for Otezla and 3.3% for the placebo. The discontinuation rate was significantly higher for Otezla than for Piclidenoson. In achieving psoriasis disability index (PDI) response at week 32, Piclidenoson was comparable to Otezla. Patients treated with Piclidenoson showed an improving progressive response over time, a critically important finding given psoriasis is a chronic disease that may require long-term treatment.

Pivotal Phase III Psoriasis Registration Study is Under Preparation for Submission to FDA & EMA – The pivotal Phase III psoriasis study’s protocol is being developed in conjunction with Dr. Kim Papp, a Key Opinion Leader in dermatology and an investigator in the COMFORT study. Marketing registration plans including chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are being prepared for submission to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Piclidenoson in the treatment of moderate to severe psoriasis.

Safety Study of Piclidenoson for Osteoarthritis in Dogs Successfully Concluded, Efficacy Study to Commence – Following a successful safety study in dogs that explored dose-range safety and pharmacokinetics, Piclidenoson is set to enter efficacy studies in the treatment of canine osteoarthritis through a development and commercialization agreement signed with Vetbiolix, a France based veterinary biotech company. Vetbiolix is financially responsible for the clinical studies. The canine osteoarthritis market is projected to reach $3 billion by 2028 and regulatory approval pathways tend to be shorter than those required for humans.

“The latest Phase III findings for Piclidenoson are highly encouraging and inform the potential for a successful psoriasis registration study which will be conducted under both the FDA and EMA. A favorable outcome could mean marketing approval in two of the largest markets in the world,” stated Can-Fite CEO Dr. Pnina Fishman. “While we have distribution agreements in place for Piclidenoson and Namodenoson in the treatment of psoriasis and liver cancer in certain European and Asian markets, we maintain full distribution rights for these late-stage assets in the U.S., the largest market in the world. We are strategically evaluating partnerships in the U.S. as we continue to forge ahead on each of our other indications including Namodenoson in NASH and Piclidenoson for canine osteoarthritis.”

Financial Results

Revenues for the nine months ended September 30, 2022 were $0.61 million, a decrease of $0.04 million, or 6.1%, compared to $0.65 million for the nine months ended September 30, 2021. The decrease is considered to be not material.

Research and development expenses for the nine months ended September 30, 2022 were $5.31 million, a decrease of $1.44 million, or 21.3%, compared to $6.75 million for the nine months ended September 30, 2021. Research and development expenses for the nine months ended September 30, 2022 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to the wrap up of the Phase III study of Piclidenoson for the treatment of psoriasis in 2022.

General and administrative expenses for the nine months ended September 30, 2022 were $2.31 million a decrease of $0.40 million, or 14.7%, compared to $2.71 million for the nine months ended September 30, 2021. The decrease is primarily due to the decrease in professional services and public and investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2022.

Financial expenses, net for the nine months ended September 30, 2022 were $0.14 million compared to finance income, net of $0.31 million for the nine months ended September 30, 2021. The decrease in financial income, net was mainly due to revaluation of the Company’s short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.

Net loss for the nine months ended September 30, 2022 was $7.15 million compared with a net loss of $8.50 million for the nine months ended September 30, 2021. The decrease in net loss for the nine months ended September 30, 2022 was primarily attributable to a decrease in research and development expenses and a decrease in general and administrative expenses.

As of September 30, 2022, Can-Fite had cash and cash equivalents and short term deposits of $10.79 million as compared to $18.90 million at December 31, 2021. The decrease in cash during the nine months ended September 30, 2022 is due to the ongoing operations of the Company.

The Company’s consolidated financial results for the nine months ended September 30, 2022 are presented in accordance with US GAAP Reporting Standards.

CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

September
30,

December
31,

2022

2021

Unaudited

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

$

3,727

$

4,390

Short term deposit

7,071

14,512

Prepaid expenses and other current assets

1,752

929

Short-term investment

15

237

Total current assets

12,565

20,068

NON-CURRENT ASSETS:

Operating lease right of use assets

98

138

Property, plant and equipment, net

43

47

Total non-current assets

141

185

Total assets

$

12,706

$

20,253

CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

September
30,

December
31,

2022

2021

Unaudited

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES:

Trade payables

$

1,472

$

954

Current maturity of operating lease liability

48

53

Deferred revenues

818

818

Other accounts payable

458

905

Total current liabilities

2,796

2,730

NON-CURRENT LIABILITIES:

Long – term operating lease liability

26

71

Deferred revenues

2,456

3,070

Total non-current liabilities

2,482

3,141

CONTIGENT LIABILITIES AND COMMITMENTS

SHAREHOLDERS’ EQUITY:

Ordinary shares of NIS 0.25 par value – Authorized: 5,000,000,000 shares at September

30, 2022 and December 31, 2021; Issued and outstanding: 815,746,293 shares as of

September 30, 2022 and December 31, 2021

60,654

60,654

Additional paid-in capital

93,475

93,275

Accumulated other comprehensive income

1,127

1,127

Accumulated deficit

(147,828

)

(140,674

)

Total shareholders’ equity

7,428

14,382

Total liabilities and shareholders’ equity

$

12,706

$

20,253

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S dollars in thousands (except for share and per share data)

Nine months ended

September 30,

2022

2021

Revenues

$

613

$

649

Research and development expenses

(5,309

)

(6,749

)

General and administrative expenses

(2,317

)

(2,714

)

Operating loss

(7,013

)

(8,814

)

Total financial income (expense), net

(141

)

317

Net loss

$

(7,154

)

$

(8,497

)

Basic and diluted net loss per share

$

(0.01

)

$

(0.02

)

Weighted average number of ordinary shares used in computing basic and

diluted net loss per share

815,746,293

515,918,123

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business,…



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